CompletedNCT02978183Updated Apr 10, 2023Results posted

Evaluation of the Effectiveness of ST266 Ophthalmic Drops Compared to Placebo to Treat Allergic Conjunctivitis

A Phase 2 interventional study of ST266 and Saline (0.9% NaCl) in Allergic Conjunctivitis, sponsored by Noveome Biotherapeutics, formerly Stemnion. Completed at 2 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-04-10.

Sponsored by Noveome Biotherapeutics, formerly Stemnion · Phase 2, Interventional, and Treatment

Phase: Phase 2
Study type: Interventional
Enrollment: 70
Allocation: Randomized
Ages: 18 Years and older
Sex: All

Study summary

The purpose of this study is to evaluate the efficacy of ST266 ophthalmic drops compared to placebo for the treatment of the signs and symptoms of allergic conjunctivitis.

Read the detailed description

The study is a multi-center, double-masked, randomized, placebo-controlled, modified conjunctival allergen challenge (CAC) model. The primary endpoints of ocular itching and conjunctival redness will be evaluated at the subject's final visit. Subjects who meet inclusion criteria will be randomized to one of two treatment groups (1:1). Randomization will be stratified by average post-CAC itching scores at baseline.

Subjects will be evaluated at baseline and on Days 6, 7 and 8.

Conditions studied

Allergic Conjunctivitis

Browse trials for

Conjunctivitis, Allergic 210

In context

Conjunctivitis, Allergic

210 studies on the registry are indexed under Conjunctivitis, Allergic; 18 are open to participants now.

This study's enrollment of 70 is below the median of 87 across 174 interventional studies indexed under Conjunctivitis, Allergic.

Browse Conjunctivitis, Allergic studies →

Lead sponsor

Noveome Biotherapeutics, formerly Stemnion is the lead sponsor of 13 studies on the registry; 1 is open to participants now.

Of its 5 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years and older
Sexes eligible: All
Accepts healthy volunteers: No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

be at least 18 years of age of either gender and any race;
provide written and sign the HIPAA form;
be willing and able to follow all instructions and attend all study visits; have a positive history of ocular allergies and a positive skin test reaction to a seasonal AND perennial allergen as confirmed by an allergic skin test;
be able and willing to avoid all disallowed medication for the appropriate and during the study;
be able and willing to discontinue wearing contact lenses for at least 72 hours prior to and during the study trial period;
(for females capable of becoming pregnant) agree to have urine pregnancy testing performed at screening (must be negative) and at the study exit; must not be lactating; and must agree to use a medically acceptable form of throughout the study duration and for at least 14 days prior to instillation of product). Women considered capable of becoming pregnant include all females who have experienced menarche and have not experienced menopause (as defined by amenorrhea for greater than 12 consecutive months) or have not undergone successful surgical sterilization (hysterectomy, bilateral tubal ligation, or bilateral oophorectomy);
have a calculated visual acuity of 0.7 logMAR or better in each eye as measured using an ETDRS chart;
have a positive post-CAC reaction;
have a positive post-CAC reaction in two out of the first three time points;
be able to self-administer eye drops satisfactorily or have a caregiver at home routinely available for this purpose.

Exclusion criteria

Exclusion Criteria:

have known or sensitivities to the use of the product or any of its components;
have any ocular condition that, in the opinion of the investigator, could affect the subject's safety or trial parameters (including but not limited to narrow angle glaucoma, blepharitis, follicular conjunctivitis, iritis, or pterygium);
have had ocular surgical intervention within 3 months prior to initiating the study or during the study and/or a history of refractive surgery within the past 6 months;
have a known history of retinal detachment, diabetic retinopathy, or active retinal disease;
have the presence of an active ocular infection (bacterial, viral or fungal) or positive history of an ocular herpetic infection at any visit;
use any of the disallowed medications during the period indicated prior to and during the study;
have any significant illness (e.g. any disease requiring therapy, severe cardiovascular disease [including arrhythmias]) the investigator feels could be expected to interfere with the subject's health or with the study parameters and/or put the subject at any unnecessary risk (includes but is not limited to: poorly controlled hypertension or poorly controlled diabetes, a history of status asthmaticus, organ transplants, a known history of persistent moderate or severe asthma, or a known history of moderate to severe allergic asthmatic reactions to any of the study allergens);
manifest signs or symptoms of clinically active allergic conjunctivitis in either eye at the screening visit;
have planned surgery (ocular or systemic) during the trial period or within 30 days after;
have used an investigational drug or medical device within 30 days of the study or be concurrently enrolled in another investigational product trial;
be a female who is currently pregnant, planning a pregnancy, or lactating.
have cancer or have a history of cancer within the last 5 years.

Terms in these criteria, in plain language(7)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Washout period

A planned gap after a treatment, so that its effects can lessen before the study treatment or a study assessment. Ask the study team and the doctor who prescribed it before changing any medicine.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

Autoimmune disease

A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.

Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.

Study design

Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Double (Participant, Investigator)
Enrollment: 70 participants (actual)

Study arms

Active comparator
Group 1
1X ST266 dosed 4 times a day for 8 days
Biological: ST266
Placebo comparator
Group 2
Placebo dosed 4 times a day for 8 days
Drug: Saline (0.9% NaCl)

Interventions

BiologicalST266
One (1) drop of 1X ST266 ophthalmic eye drops will be administered to each eye 4 times a day for 8 days.
DrugSaline (0.9% NaCl)
One (1) drop of saline ophthalmic eye drops will be administered to each eye 4 times a day for 8 days.

What researchers measure

Primary outcomes

Ocular Itching
Ocular itching evaluated by the subject. Ocular itching was evaluated on a 0-4 scale (with half unit increments allowed). Lower scores indicated less itching.
Time frame: Day 7 and 8
Conjunctival Redness
Conjunctival redness evaluated by the investigator. Conjunctival redness was evaluated on a 0-4 scale (with half unit increments allowed). Lower scores indicated less redness.
Time frame: Day 7 and 8

Secondary outcomes

Ciliary Redness
Ciliary redness evaluated by the investigator. Ciliary redness was evaluated on a 0-4 scale (with half unit increments allowed). A lower score was indicative of less redness.
Time frame: Day 7 and 8
Episcleral Redness
Episcleral redness evaluated by the investigator. Episcleral redness was evaluated on a 0-4 scale (with half unit increments allowed). A lower score was indicative of less redness.
Time frame: Day 7 and 8
Chemosis
Chemosis evaluated by the investigator. Chemosis was evaluated on a 0-4 scale (with half unit increments allowed). A lower score was indicative of less chemosis.
Time frame: Day 7 and 8
Eyelid Swelling
Eyelid swelling evaluated by the subject. Eyelid swelling was evaluated on a 0-4 scale in which 0.5 unit increments were not allowed. A lower score was indicative of less swelling.
Time frame: Day 7 and 8
Tearing/Watery Eyes
Tearing evaluated by the subject. Tearing was evaluated on a 0-4 scale in which 0.5 unit increments were not allowed. A lower score was indicative of less tearing.
Time frame: Day 7 and 8
Rhinorrhea
Rhinorrhea evaluated by the subject. Rhinorrhea was evaluated on a 0-4 scale in which 0.5 unit increments were not allowed. A lower score was indicative of less severity.
Time frame: Day 7 and 8
Nasal Pruritus
Nasal Pruritus evaluated by the subject. Nasal pruritus was evaluated on a 0-4 scale in which 0.5 unit increments were not allowed. A lower score was indicative of less severity.
Time frame: Day 7 and 8
Ear or Palate Pruritus
Ear or palate pruritus evaluated by the subject. Ear or palate pruritus was evaluated on a 0-4 scale in which 0.5 unit increments were not allowed. A lower score was indicative of less severity.
Time frame: Day 7 and 8
Nasal Congestion
Nasal congestion evaluated by the subject. Nasal congestion was evaluated on a 0-4 scale in which 0.5 unit increments were not allowed. A lower score was indicative of less severity.
Time frame: Day 7 and 8
Nasal Composite Score
A composite score of presence or absence of at least one nasal symptom evaluated by the subject
Time frame: Day 7 and 8

Results

Posted Sep 16, 2021

Participant flow

Participant flow — Overall Study
Milestone	Group 1	Group 2
Started	34	36
Completed	34	36
Not completed	0	0

Outcome measures

PrimaryOcular Itching

Ocular itching evaluated by the subject. Ocular itching was evaluated on a 0-4 scale (with half unit increments allowed). Lower scores indicated less itching.

Time frame:: Day 7 and 8
Reported as:: Mean · score on a scale

Ocular Itching
score on a scale	Group 1	Group 2
Day 7, Pre-Conjunctival Allergen Challenge	0.508 ± 0.8373	0.139 ± 0.3131
Day 7, 5 Minutes Post Conjunctival Allergen Challenge	2.485 ± 0.9533	2.535 ± 1.1070
Day 7, 7 Minutes Post Conjunctival Allergen Challenge	2.559 ± 0.9887	2.576 ± 1.1113
Day 7, 10 Minutes Post Conjunctival Allergen Challenge	2.434 ± 0.9320	2.458 ± 1.1124
Day 7, 15 Minutes Post Conjunctival Allergen Challenge	2.154 ± 0.9415	2.181 ± 1.1520
Day 7, 20 Minutes Post Conjunctival Allergen Challenge	1.838 ± 0.9960	1.910 ± 1.1482
Day 7, 25 Minutes Post Conjunctival Allergen Challenge	1.529 ± 0.9103	1.722 ± 1.1707
Day 7, 30 Minutes Post Conjunctival Allergen Challenge	1.346 ± 0.9435	1.583 ± 1.1164
Day 8, pre-Conjunctival Allergen Challenge	0.449 ± 0.7405	0.167 ± 0.3827
Day 8, 5 Minutes Post Conjunctival Allergen Challenge	2.816 ± 0.8968	2.618 ± 0.9847
Day 8, 7 Minutes Post Conjunctival Allergen Challenge	2.787 ± 0.9316	2.625 ± 0.9865
Day 8, 10 Minutes Post Conjunctival Allergen Challenge	2.588 ± 0.9903	2.604 ± 1.0357
Day 8, 15 Minutes Post Conjunctival Allergen Challenge	2.309 ± 0.9654	2.299 ± 1.0804
Day 8, 20 Minutes Post Conjunctival Allergen Challenge	2.081 ± 0.9389	1.986 ± 1.1354
Day 8, 25 Minutes Post Conjunctival Allergen Challenge	1.765 ± 0.9573	1.819 ± 1.1158
Day 8, 30 Minutes Post Conjunctival Allergen Challenge	1.493 ± 0.9262	1.590 ± 1.1167

Statistical analysis

Group 1 vs Group 2 · ANCOVA · p = 0.0882 (Adjustments for multiplicity were not employed)
Group 1 vs Group 2 · ANCOVA · p = 0.8032 (Adjustments for multiplicity were not employed)
Group 1 vs Group 2 · ANCOVA · p = 0.9003 (Adjustments for multiplicity were not employed)
Group 1 vs Group 2 · ANCOVA · p = 0.9523 (Adjustments for multiplicity were not employed)
Group 1 vs Group 2 · ANCOVA · p = 0.9071 (Adjustments for multiplicity were not employed)
Group 1 vs Group 2 · ANCOVA · p = 0.7509 (Adjustments for multiplicity were not employed)
Group 1 vs Group 2 · ANCOVA · p = 0.2824 (Adjustments for multiplicity were not employed)
Group 1 vs Group 2 · ANCOVA · p = 0.4017 (Adjustments for multiplicity were not employed)
Group 1 vs Group 2 · ANCOVA · p = 0.4497 (Adjustments for multiplicity were not employed)
Group 1 vs Group 2 · ANCOVA · p = 0.1650 (Adjustments for multiplicity were not employed)
Group 1 vs Group 2 · ANCOVA · p = 0.3494 (Adjustments for multiplicity were not employed)
Group 1 vs Group 2 · ANCOVA · p = 0.4781 (Adjustments for multiplicity were not employed)
Group 1 vs Group 2 · ANCOVA · p = 0.9847 (Adjustments for multiplicity were not employed)
Group 1 vs Group 2 · ANCOVA · p = 0.9731 (Adjustments for multiplicity were not employed)
Group 1 vs Group 2 · ANCOVA · p = 0.6984 (Adjustments for multiplicity were not employed)
Group 1 vs Group 2 · ANCOVA · p = 0.6265 (Adjustments for multiplicity were not employed)
Group 1 vs Group 2 · ANCOVA · p = 0.7848 (Adjustments for multiplicity were not employed)
Group 1 vs Group 2 · ANCOVA · p = 0.5789 (Adjustments for multiplicity were not employed)

PrimaryConjunctival Redness

Conjunctival redness evaluated by the investigator. Conjunctival redness was evaluated on a 0-4 scale (with half unit increments allowed). Lower scores indicated less redness.

Time frame:: Day 7 and 8
Reported as:: Mean · score on a scale

Conjunctival Redness
score on a scale	Group 1	Group 2
Day 7, Pre-Conjunctival Allergen Challenge	1.103 ± 0.7541	1.028 ± 0.5818
Day 7, 10 Minutes Post Conjunctival Allergen Challenge	2.125 ± 0.8817	1.958 ± 0.8814
Day 7, 15 Minutes Post Conjunctival Allergen Challenge	1.897 ± 0.9714	1.882 ± 0.9073
Day 7, 20 Minutes Post Conjunctival Allergen Challenge	1.926 ± 1.0308	1.771 ± 0.8481
Day 7, 25 Minutes Post Conjunctival Allergen Challenge	1.875 ± 1.0005	1.743 ± 0.8377
Day 7, 30 Minutes Post Conjunctival Allergen Challenge	1.816 ± 1.0323	1.681 ± 0.8775
Day 8, Pre-Conjunctival Allergen Challenge	0.912 ± 0.6682	0.819 ± 0.4766
Day 8, 10 Minutes Post Conjunctival Allergen Challenge	1.963 ± 0.7909	1.917 ± 0.7319
Day 8, 15 Minutes Post Conjunctival Allergen Challenge	1.963 ± 0.8075	2.111 ± 0.7870
Day 8, 20 Minutes Post Conjunctival Allergen Challenge	1.882 ± 0.8101	1.951 ± 0.8036
Day 8, 25 Minutes Post Conjunctival Allergen Challenge	1.735 ± 0.8549	1.785 ± 0.8241
Day 8, 30 Minutes Post Conjunctival Allergen Challenge	1.596 ± 0.8791	1.625 ± 0.7476

Statistical analysis

Group 1 vs Group 2 · ANCOVA · p = 0.8165 (Adjustments for multiplicity were not employed)
Group 1 vs Group 2 · ANCOVA · p = 0.6590 (Adjustments for multiplicity were not employed)
Group 1 vs Group 2 · ANCOVA · p = 0.7455 (Adjustments for multiplicity were not employed)
Group 1 vs Group 2 · ANCOVA · p = 0.9212 (Adjustments for multiplicity were not employed)
Group 1 vs Group 2 · ANCOVA · p = 0.9509 (Adjustments for multiplicity were not employed)
Group 1 vs Group 2 · ANCOVA · p = 0.7897 (Adjustments for multiplicity were not employed)
Group 1 vs Group 2 · ANCOVA · p = 0.3183 (Adjustments for multiplicity were not employed)
Group 1 vs Group 2 · ANCOVA · p = 0.7604 (Adjustments for multiplicity were not employed)
Group 1 vs Group 2 · ANCOVA · p = 0.7343 (Adjustments for multiplicity were not employed)
Group 1 vs Group 2 · ANCOVA · p = 0.1530 (Adjustments for multiplicity were not employed)
Group 1 vs Group 2 · ANCOVA · p = 0.3307 (Adjustments for multiplicity were not employed)
Group 1 vs Group 2 · ANCOVA · p = 0.3399 (Adjustments for multiplicity were not employed)
Group 1 vs Group 2 · ANCOVA · p = 0.5137 (Adjustments for multiplicity were not employed)
Group 1 vs Group 2 · ANCOVA · p = 0.9962 (Adjustments for multiplicity were not employed)

SecondaryCiliary Redness

Ciliary redness evaluated by the investigator. Ciliary redness was evaluated on a 0-4 scale (with half unit increments allowed). A lower score was indicative of less redness.

Time frame:: Day 7 and 8
Reported as:: Mean · score on a scale

Ciliary Redness
score on a scale	Group 1	Group 2
Day 7, Pre-Conjunctival Allergen Challenge	0.912 ± 0.6243	0.750 ± 0.5445
Day 7, 10 Minutes Post Conjunctival Allergen Challenge	1.838 ± 0.8368	1.799 ± 0.8341
Day 7, 15 Minutes Post Conjunctival Allergen Challenge	1.691 ± 0.9925	1.729 ± 0.8353
Day 7, 20 Minutes Post Conjunctival Allergen Challenge	1.713 ± 0.9417	1.625 ± 0.8420
Day 7, 25 Minutes Post Conjunctival Allergen Challenge	1.654 ± 0.9150	1.583 ± 0.7488
Day 7, 30 Minutes Post Conjunctival Allergen Challenge	1.603 ± 0.9869	1.493 ± 0.8608
Day 8, pre-Conjunctival Allergen Challenge	0.581 ± 0.6053	0.521 ± 0.4487
Day 8, 10 Minutes Post Conjunctival Allergen Challenge	1.691 ± 0.8189	1.743 ± 0.7058
Day 8, 15 Minutes Post Conjunctival Allergen Challenge	1.699 ± 0.7804	1.931 ± 0.7310
Day 8, 20 Minutes Post Conjunctival Allergen Challenge	1.625 ± 0.8556	1.792 ± 0.7688
Day 8, 25 Minutes Post Conjunctival Allergen Challenge	1.463 ± 0.9027	1.569 ± 0.7806
Day 8, 30 Minutes Post Conjunctival Allergen Challenge	1.346 ± 0.8528	1.458 ± 0.8007

Statistical analysis

Group 1 vs Group 2 · ANCOVA · p = 0.3259 (Adjustments for multiplicity were not employed)
Group 1 vs Group 2 · ANCOVA · p = 0.9785 (Adjustments for multiplicity were not employed)
Group 1 vs Group 2 · ANCOVA · p = 0.5112 (Adjustments for multiplicity were not employed)
Group 1 vs Group 2 · ANCOVA · p = 0.7771 (Adjustments for multiplicity were not employed)
Group 1 vs Group 2 · ANCOVA · p = 0.6232 (Adjustments for multiplicity were not employed)
Group 1 vs Group 2 · ANCOVA · p = 0.8895 (Adjustments for multiplicity were not employed)
Group 1 vs Group 2 · ANCOVA · p = 0.8974 (Adjustments for multiplicity were not employed)
Group 1 vs Group 2 · ANCOVA · p = 0.9604 (Adjustments for multiplicity were not employed)
Group 1 vs Group 2 · ANCOVA · p = 0.5301 (Adjustments for multiplicity were not employed)
Group 1 vs Group 2 · ANCOVA · p = 0.0386 (Adjustments for multiplicity were not employed)
Group 1 vs Group 2 · ANCOVA · p = 0.1034 (Adjustments for multiplicity were not employed)
Group 1 vs Group 2 · ANCOVA · p = 0.0985 (Adjustments for multiplicity were not employed)
Group 1 vs Group 2 · ANCOVA · p = 0.2342 (Adjustments for multiplicity were not employed)
Group 1 vs Group 2 · ANCOVA · p = 0.3016 (Adjustments for multiplicity were not employed)

SecondaryEpiscleral Redness

Episcleral redness evaluated by the investigator. Episcleral redness was evaluated on a 0-4 scale (with half unit increments allowed). A lower score was indicative of less redness.

Time frame:: Day 7 and 8
Reported as:: Mean · score on a scale

Episcleral Redness
score on a scale	Group 1	Group 2
Day 7, Pre-Conjunctival Allergen Challenge	1.029 ± 0.6622	0.910 ± 0.5579
Day 7, 10 Minutes Post Conjunctival Allergen Challenge	1.868 ± 0.8217	1.819 ± 0.8401
Day 7, 15 Minutes Post Conjunctival Allergen Challenge	1.757 ± 0.9283	1.778 ± 0.8468
Day 7, 20 Minutes Post Conjunctival Allergen Challenge	1.787 ± 0.9656	1.701 ± 0.8036
Day 7, 25 Minutes Post Conjunctival Allergen Challenge	1.721 ± 0.9939	1.618 ± 0.7500
Day 7, 30 Minutes Post Conjunctival Allergen Challenge	1.669 ± 1.0275	1.583 ± 0.8345
Day 8, pre-Conjunctival Allergen Challenge	0.507 ± 0.5822	0.424 ± 0.4544
Day 8, 10 Minutes Post Conjunctival Allergen Challenge	1.735 ± 0.8210	1.708 ± 0.6827
Day 8, 15 Minutes Post Conjunctival Allergen Challenge	1.706 ± 0.8404	1.896 ± 0.7055
Day 8, 20 Minutes Post Conjunctival Allergen Challenge	1.647 ± 0.8144	1.701 ± 0.7508
Day 8, 25 Minutes Post Conjunctival Allergen Challenge	1.412 ± 0.8680	1.583 ± 0.7488
Day 8, 30 Minutes Post Conjunctival Allergen Challenge	1.353 ± 0.8575	1.347 ± 0.7495

Statistical analysis

Group 1 vs Group 2 · ANCOVA · p = 0.4927 (Adjustments for multiplicity were not employed)
Group 1 vs Group 2 · ANCOVA · p = 0.8686 (Adjustments for multiplicity were not employed)
Group 1 vs Group 2 · ANCOVA · p = 0.5772 (Adjustments for multiplicity were not employed)
Group 1 vs Group 2 · ANCOVA · p = 0.9700 (Adjustments for multiplicity were not employed)
Group 1 vs Group 2 · ANCOVA · p = 0.7516 (Adjustments for multiplicity were not employed)
Group 1 vs Group 2 · ANCOVA · p = 0.9532 (Adjustments for multiplicity were not employed)
Group 1 vs Group 2 · ANCOVA · p = 0.7522 (Adjustments for multiplicity were not employed)
Group 1 vs Group 2 · ANCOVA · p = 0.6804 (Adjustments for multiplicity were not employed)
Group 1 vs Group 2 · ANCOVA · p = 0.6267 (Adjustments for multiplicity were not employed)
Group 1 vs Group 2 · ANCOVA · p = 0.0976 (Adjustments for multiplicity were not employed)
Group 1 vs Group 2 · ANCOVA · p = 0.4687
Group 1 vs Group 2 · ANCOVA · p = 0.0421 (Adjustments for multiplicity were not employed)
Group 1 vs Group 2 · ANCOVA · p = 0.6085 (Adjustments for multiplicity were not employed)
Group 1 vs Group 2 · ANCOVA · p = 0.9634 (Adjustments for multiplicity were not employed)

SecondaryChemosis

Chemosis evaluated by the investigator. Chemosis was evaluated on a 0-4 scale (with half unit increments allowed). A lower score was indicative of less chemosis.

Time frame:: Day 7 and 8
Reported as:: Mean · score on a scale

Chemosis
score on a scale	Group 1	Group 2
Day 7, Pre-Conjunctival Allergen Challenge	0.390 ± 0.3703	0.465 ± 0.3787
Day 7, 10 Minutes Post Conjunctival Allergen Challenge	0.765 ± 0.4306	0.840 ± 0.4711
Day 7, 15 Minutes Post Conjunctival Allergen Challenge	0.669 ± 0.5391	0.708 ± 0.4762
Day 7, 20 Minutes Post Conjunctival Allergen Challenge	0.691 ± 0.5709	0.778 ± 0.4259
Day 7, 25 Minutes Post Conjunctival Allergen Challenge	0.691 ± 0.6001	0.785 ± 0.5146
Day 7, 30 Minutes Post Conjunctival Allergen Challenge	0.676 ± 0.6047	0.757 ± 0.4075
Day 8, pre-Conjunctival Allergen Challenge	0.081 ± 0.2280	0.104 ± 0.1925
Day 8, 10 Minutes Post Conjunctival Allergen Challenge	0.574 ± 0.6262	0.674 ± 0.4994
Day 8, 15 Minutes Post Conjunctival Allergen Challenge	0.632 ± 0.7288	0.764 ± 0.4265
Day 8, 20 Minutes Post Conjunctival Allergen Challenge	0.684 ± 0.7792	0.708 ± 0.4571
Day 8, 25 Minutes Post Conjunctival Allergen Challenge	0.566 ± 0.7444	0.590 ± 0.5674
Day 8, 30 Minutes Post Conjunctival Allergen Challenge	0.551 ± 0.8137	0.493 ± 0.6196

Statistical analysis

Group 1 vs Group 2 · ANCOVA · p = 0.3322 (Adjustments for multiplicity were not employed)
Group 1 vs Group 2 · ANCOVA · p = 0.8026 (Adjustments for multiplicity were not employed)
Group 1 vs Group 2 · ANCOVA · p = 0.9981 (Adjustments for multiplicity were not employed)
Group 1 vs Group 2 · ANCOVA · p = 0.5645 (Adjustments for multiplicity were not employed)
Group 1 vs Group 2 · ANCOVA · p = 0.5455 (Adjustments for multiplicity were not employed)
Group 1 vs Group 2 · ANCOVA · p = 0.6980 (Adjustments for multiplicity were not employed)
Group 1 vs Group 2 · ANCOVA · p = 0.6115 (Adjustments for multiplicity were not employed)
Group 1 vs Group 2 · ANCOVA · p = 0.4528 (Adjustments for multiplicity were not employed)
Group 1 vs Group 2 · ANCOVA · p = 0.7551 (Adjustments for multiplicity were not employed)
Group 1 vs Group 2 · ANCOVA · p = 0.5318 (Adjustments for multiplicity were not employed)
Group 1 vs Group 2 · ANCOVA · p = 0.9748 (Adjustments for multiplicity were not employed)
Group 1 vs Group 2 · ANCOVA · p = 0.7706 (Adjustments for multiplicity were not employed)
Group 1 vs Group 2 · ANCOVA · p = 0.3414 (Adjustments for multiplicity were not employed)
Group 1 vs Group 2 · ANCOVA · p = 0.4361 (Adjustments for multiplicity were not employed)

SecondaryEyelid Swelling

Eyelid swelling evaluated by the subject. Eyelid swelling was evaluated on a 0-4 scale in which 0.5 unit increments were not allowed. A lower score was indicative of less swelling.

Time frame:: Day 7 and 8
Reported as:: Mean · score on a scale

Eyelid Swelling
score on a scale	Group 1	Group 2
Day 7, Pre-Conjunctival Allergen Challenge	0.45 ± 0.711	0.22 ± 0.404
Day 7, 10 Minutes Post Conjunctival Allergen Challenge	1.22 ± 0.889	1.39 ± 0.871
Day 7, 15 Minutes Post Conjunctival Allergen Challenge	1.25 ± 0.915	1.33 ± 0.837
Day 7, 20 Minutes Post Conjunctival Allergen Challenge	1.06 ± 0.776	1.25 ± 0.841
Day 7, 25 Minutes Post Conjunctival Allergen Challenge	0.96 ± 0.711	1.22 ± 0.857
Day 7, 30 Minutes Post Conjunctival Allergen Challenge	0.79 ± 0.780	0.97 ± 0.836
Day 8, pre-Conjunctival Allergen Challenge	0.41 ± 0.621	0.26 ± 0.500
Day 8, 10 Minutes Post Conjunctival Allergen Challenge	1.35 ± 0.744	1.21 ± 0.873
Day 8, 15 Minutes Post Conjunctival Allergen Challenge	1.29 ± 0.740	1.19 ± 0.881
Day 8, 20 Minutes Post Conjunctival Allergen Challenge	1.12 ± 0.817	1.11 ± 0.887
Day 8, 25 Minutes Post Conjunctival Allergen Challenge	0.94 ± 0.766	1.10 ± 0.893
Day 8, 30 Minutes Post Conjunctival Allergen Challenge	0.81 ± 0.728	0.89 ± 0.887

Statistical analysis

Group 1 vs Group 2 · ANCOVA · p = 0.0603 (Adjustments for multiplicity were not employed)
Group 1 vs Group 2 · ANCOVA · p = 0.4857 (Adjustments for multiplicity were not employed)
Group 1 vs Group 2 · ANCOVA · p = 0.9815 (Adjustments for multiplicity were not employed)
Group 1 vs Group 2 · ANCOVA · p = 0.6213 (Adjustments for multiplicity were not employed)
Group 1 vs Group 2 · ANCOVA · p = 0.1831 (Adjustments for multiplicity were not employed)
Group 1 vs Group 2 · ANCOVA · p = 0.6489 (Adjustments for multiplicity were not employed)
Group 1 vs Group 2 · ANCOVA · p = 0.2622 (Adjustments for multiplicity were not employed)
Group 1 vs Group 2 · ANCOVA · p = 0.2397 (Adjustments for multiplicity were not employed)
Group 1 vs Group 2 · ANCOVA · p = 0.3202 (Adjustments for multiplicity were not employed)
Group 1 vs Group 2 · ANCOVA · p = 0.2663 (Adjustments for multiplicity were not employed)
Group 1 vs Group 2 · ANCOVA · p = 0.5672 (Adjustments for multiplicity were not employed)
Group 1 vs Group 2 · ANCOVA · p = 0.5055 (Adjustments for multiplicity were not employed)
Group 1 vs Group 2 · ANCOVA · p = 0.8143 (Adjustments for multiplicity were not employed)
Group 1 vs Group 2 · ANCOVA · p = 0.6901 (Adjustments for multiplicity were not employed)

SecondaryTearing/Watery Eyes

Tearing evaluated by the subject. Tearing was evaluated on a 0-4 scale in which 0.5 unit increments were not allowed. A lower score was indicative of less tearing.

Time frame:: Day 7 and 8
Reported as:: Mean · score on a scale

Tearing/Watery Eyes
score on a scale	Group 1	Group 2
Day 7, Pre-Conjunctival Allergen Challenge	0.38 ± 0.707	0.21 ± 0.437
Day 7, 10 Minutes Post Conjunctival Allergen Challenge	1.15 ± 0.966	1.38 ± 1.024
Day 7, 15 Minutes Post Conjunctival Allergen Challenge	0.88 ± 1.038	1.22 ± 1.003
Day 7, 20 Minutes Post Conjunctival Allergen Challenge	0.72 ± 0.898	1.07 ± 0.965
Day 7, 25 Minutes Post Conjunctival Allergen Challenge	0.71 ± 0.930	0.94 ± 1.034
Day 7, 30 Minutes Post Conjunctival Allergen Challenge	0.65 ± 0.875	0.85 ± 0.909
Day 8, pre-Conjunctival Allergen Challenge	0.37 ± 0.810	0.28 ± 0.553
Day 8, 10 Minutes Post Conjunctival Allergen Challenge	1.07 ± 1.074	1.15 ± 0.970
Day 8, 15 Minutes Post Conjunctival Allergen Challenge	1.04 ± 1.090	1.13 ± 0.929
Day 8, 20 Minutes Post Conjunctival Allergen Challenge	0.87 ± 0.864	1.01 ± 0.906
Day 8, 25 Minutes Post Conjunctival Allergen Challenge	0.76 ± 0.809	1.00 ± 0.956
Day 8, 30 Minutes Post Conjunctival Allergen Challenge	0.65 ± 0.803	0.88 ± 0.952

Statistical analysis

Group 1 vs Group 2 · ANCOVA · p = 0.4032 (Adjustments for multiplicity were not employed)
Group 1 vs Group 2 · ANCOVA · p = 0.2946 (Adjustments for multiplicity were not employed)
Group 1 vs Group 2 · ANCOVA · p = 0.2863 (Adjustments for multiplicity were not employed)
Group 1 vs Group 2 · ANCOVA · p = 0.0891 (Adjustments for multiplicity were not employed)
Group 1 vs Group 2 · ANCOVA · p = 0.5347 (Adjustments for multiplicity were not employed)
Group 1 vs Group 2 · ANCOVA · p = 0.3733 (Adjustments for multiplicity were not employed)
Group 1 vs Group 2 · ANCOVA · p = 0.2506 (Adjustments for multiplicity were not employed)
Group 1 vs Group 2 · ANCOVA · p = 0.8667 (Adjustments for multiplicity were not employed)
Group 1 vs Group 2 · ANCOVA · p = 0.7640 (Adjustments for multiplicity were not employed)
Group 1 vs Group 2 · ANCOVA · p = 0.8008 (Adjustments for multiplicity were not employed)
Group 1 vs Group 2 · ANCOVA · p = 0.4729 (Adjustments for multiplicity were not employed)
Group 1 vs Group 2 · ANCOVA · p = 0.4742 (Adjustments for multiplicity were not employed)
Group 1 vs Group 2 · ANCOVA · p = 0.2922 (Adjustments for multiplicity were not employed)
Group 1 vs Group 2 · ANCOVA · p = 0.3657 (Adjustments for multiplicity were not employed)

SecondaryRhinorrhea

Rhinorrhea evaluated by the subject. Rhinorrhea was evaluated on a 0-4 scale in which 0.5 unit increments were not allowed. A lower score was indicative of less severity.

Time frame:: Day 7 and 8
Reported as:: Mean · score on a scale

Rhinorrhea
score on a scale	Group 1	Group 2
Day 7, Pre-Conjunctival Allergen Challenge	0.33 ± 0.595	0.19 ± 0.525
Day 7, 10 Minutes Post Conjunctival Allergen Challenge	1.35 ± 1.152	1.47 ± 1.134
Day 7, 15 Minutes Post Conjunctival Allergen Challenge	1.18 ± 0.904	1.31 ± 1.142
Day 7, 20 Minutes Post Conjunctival Allergen Challenge	0.97 ± 0.870	0.97 ± 1.082
Day 7, 25 Minutes Post Conjunctival Allergen Challenge	0.85 ± 0.821	0.89 ± 1.090
Day 7, 30 Minutes Post Conjunctival Allergen Challenge	0.85 ± 0.784	0.94 ± 1.068
Day 8, pre-Conjunctival Allergen Challenge	0.29 ± 0.579	0.22 ± 0.591
Day 8, 10 Minutes Post Conjunctival Allergen Challenge	1.29 ± 0.938	1.39 ± 1.225
Day 8, 15 Minutes Post Conjunctival Allergen Challenge	1.26 ± 0.963	1.31 ± 1.283
Day 8, 20 Minutes Post Conjunctival Allergen Challenge	1.09 ± 0.933	1.08 ± 1.156
Day 8, 25 Minutes Post Conjunctival Allergen Challenge	1.00 ± 0.853	0.92 ± 1.180
Day 8, 30 Minutes Post Conjunctival Allergen Challenge	0.94 ± 0.776	0.83 ± 1.108

Statistical analysis

Group 1 vs Group 2 · ANCOVA · p = 0.6600 (Adjustments for multiplicity were not employed)
Group 1 vs Group 2 · ANCOVA · p = 0.6877 (Adjustments for multiplicity were not employed)
Group 1 vs Group 2 · ANCOVA · p = 0.3340 (Adjustments for multiplicity were not employed)
Group 1 vs Group 2 · ANCOVA · p = 0.7874 (Adjustments for multiplicity were not employed)
Group 1 vs Group 2 · ANCOVA · p = 0.3812 (Adjustments for multiplicity were not employed)
Group 1 vs Group 2 · ANCOVA · p = 0.6987
Group 1 vs Group 2 · ANCOVA · p = 0.6832 (Adjustments for multiplicity were not employed)
Group 1 vs Group 2 · ANCOVA · p = 0.8521 (Adjustments for multiplicity were not employed)
Group 1 vs Group 2 · ANCOVA · p = 0.7516 (Adjustments for multiplicity were not employed)
Group 1 vs Group 2 · ANCOVA · p = 0.6252 (Adjustments for multiplicity were not employed)
Group 1 vs Group 2 · ANCOVA · p = 0.8321 (Adjustments for multiplicity were not employed)
Group 1 vs Group 2 · ANCOVA · p = 0.8173 (Adjustments for multiplicity were not employed)
Group 1 vs Group 2 · ANCOVA · p = 0.5445 (Adjustments for multiplicity were not employed)
Group 1 vs Group 2 · ANCOVA · p = 0.6810 (Adjustments for multiplicity were not employed)

SecondaryNasal Pruritus

Nasal Pruritus evaluated by the subject. Nasal pruritus was evaluated on a 0-4 scale in which 0.5 unit increments were not allowed. A lower score was indicative of less severity.

Time frame:: Day 7 and 8
Reported as:: Mean · score on a scale

Nasal Pruritus
score on a scale	Group 1	Group 2
Day 7, Pre-Conjunctival Allergen Challenge	0.30 ± 0.467	0.06 ± 0.232
Day 7, 10 Minutes Post Conjunctival Allergen Challenge	1.03 ± 1.141	1.11 ± 1.116
Day 7, 15 Minutes Post Conjunctival Allergen Challenge	0.91 ± 0.965	1.03 ± 1.082
Day 7, 20 Minutes Post Conjunctival Allergen Challenge	0.76 ± 0.923	0.89 ± 0.950
Day 7, 25 Minutes Post Conjunctival Allergen Challenge	0.76 ± 0.890	0.83 ± 0.971
Day 7, 30 Minutes Post Conjunctival Allergen Challenge	0.65 ± 0.774	0.75 ± 0.967
Day 8, pre-Conjunctival Allergen Challenge	0.24 ± 0.554	0.14 ± 0.487
Day 8, 10 Minutes Post Conjunctival Allergen Challenge	1.03 ± 1.167	0.94 ± 1.145
Day 8, 15 Minutes Post Conjunctival Allergen Challenge	1.03 ± 1.087	0.83 ± 1.082
Day 8, 20 Minutes Post Conjunctival Allergen Challenge	0.91 ± 1.111	0.69 ± 1.009
Day 8, 25 Minutes Post Conjunctival Allergen Challenge	0.68 ± 0.912	0.69 ± 1.009
Day 8, 30 Minutes Post Conjunctival Allergen Challenge	0.59 ± 0.821	0.64 ± 1.018

Statistical analysis

Group 1 vs Group 2 · ANCOVA · p = 0.0111 (Adjustments for multiplicity were not employed)
Group 1 vs Group 2 · ANCOVA · p = 0.3391 (Adjustments for multiplicity were not employed)
Group 1 vs Group 2 · ANCOVA · p = 0.2390 (Adjustments for multiplicity were not employed)
Group 1 vs Group 2 · ANCOVA · p = 0.3068 (Adjustments for multiplicity were not employed)
Group 1 vs Group 2 · ANCOVA · p = 0.4914 (Adjustments for multiplicity were not employed)
Group 1 vs Group 2 · ANCOVA · p = 0.5185 (Adjustments for multiplicity were not employed)
Group 1 vs Group 2 · ANCOVA · p = 0.5262 (Adjustments for multiplicity were not employed)
Group 1 vs Group 2 · ANCOVA · p = 0.6098 (Adjustments for multiplicity were not employed)
Group 1 vs Group 2 · ANCOVA · p = 0.8849 (Adjustments for multiplicity were not employed)
Group 1 vs Group 2 · ANCOVA · p = 0.6941 (Adjustments for multiplicity were not employed)
Group 1 vs Group 2 · ANCOVA · p = 0.5728 (Adjustments for multiplicity were not employed)
Group 1 vs Group 2 · ANCOVA · p = 0.5931 (Adjustments for multiplicity were not employed)
Group 1 vs Group 2 · ANCOVA · p = 0.7513 (Adjustments for multiplicity were not employed)
Group 1 vs Group 2 · ANCOVA · p = 0.7297 (Adjustments for multiplicity were not employed)

SecondaryEar or Palate Pruritus

Ear or palate pruritus evaluated by the subject. Ear or palate pruritus was evaluated on a 0-4 scale in which 0.5 unit increments were not allowed. A lower score was indicative of less severity.

Time frame:: Day 7 and 8
Reported as:: Mean · score on a scale

Ear or Palate Pruritus
score on a scale	Group 1	Group 2
Day 7, Pre-Conjunctival Allergen Challenge	0.33 ± 0.595	0.19 ± 0.401
Day 7, 10 Minutes Post Conjunctival Allergen Challenge	1.26 ± 1.355	1.22 ± 1.245
Day 7, 15 Minutes Post Conjunctival Allergen Challenge	1.18 ± 1.193	1.11 ± 1.214
Day 7, 20 Minutes Post Conjunctival Allergen Challenge	1.00 ± 1.073	1.08 ± 1.105
Day 7, 25 Minutes Post Conjunctival Allergen Challenge	0.91 ± 0.965	0.94 ± 1.094
Day 7, 30 Minutes Post Conjunctival Allergen Challenge	0.88 ± 0.808	0.83 ± 0.971
Day 8, pre-Conjunctival Allergen Challenge	0.06 ± 0.239	0.19 ± 0.401
Day 8, 10 Minutes Post Conjunctival Allergen Challenge	1.18 ± 1.336	1.33 ± 1.352
Day 8, 15 Minutes Post Conjunctival Allergen Challenge	1.15 ± 1.282	1.28 ± 1.344
Day 8, 20 Minutes Post Conjunctival Allergen Challenge	1.12 ± 1.274	1.19 ± 1.283
Day 8, 25 Minutes Post Conjunctival Allergen Challenge	1.00 ± 1.181	1.08 ± 1.204
Day 8, 30 Minutes Post Conjunctival Allergen Challenge	1.00 ± 1.128	0.97 ± 1.253

Statistical analysis

Group 1 vs Group 2 · ANCOVA · p = 0.1259 (Adjustments for multiplicity were not employed)
Group 1 vs Group 2 · ANCOVA · p = 0.9234 (Adjustments for multiplicity were not employed)
Group 1 vs Group 2 · ANCOVA · p = 0.8816 (Adjustments for multiplicity were not employed)
Group 1 vs Group 2 · ANCOVA · p = 0.5703 (Adjustments for multiplicity were not employed)
Group 1 vs Group 2 · ANCOVA · p = 0.5428 (Adjustments for multiplicity were not employed)
Group 1 vs Group 2 · ANCOVA · p = 0.7454 (Adjustments for multiplicity were not employed)
Group 1 vs Group 2 · ANCOVA · p = 0.8195 (Adjustments for multiplicity were not employed)
Group 1 vs Group 2 · ANCOVA · p = 0.0909 (Adjustments for multiplicity were not employed)
Group 1 vs Group 2 · ANCOVA · p = 0.4881 (Adjustments for multiplicity were not employed)
Group 1 vs Group 2 · ANCOVA · p = 0.3391 (Adjustments for multiplicity were not employed)
Group 1 vs Group 2 · ANCOVA · p = 0.6065 (Adjustments for multiplicity were not employed)
Group 1 vs Group 2 · ANCOVA · p = 0.3393 (Adjustments for multiplicity were not employed)
Group 1 vs Group 2 · ANCOVA · p = 0.8364 (Adjustments for multiplicity were not employed)
Group 1 vs Group 2 · ANCOVA · p = 0.8858 (Adjustments for multiplicity were not employed)

SecondaryNasal Congestion

Nasal congestion evaluated by the subject. Nasal congestion was evaluated on a 0-4 scale in which 0.5 unit increments were not allowed. A lower score was indicative of less severity.

Time frame:: Day 7 and 8
Reported as:: Mean · score on a scale

Nasal Congestion
score on a scale	Group 1	Group 2
Day 7, Pre-Conjunctival Allergen Challenge	0.67 ± 0.816	0.42 ± 0.906
Day 7, 10 Minutes Post Conjunctival Allergen Challenge	1.44 ± 1.160	1.47 ± 1.230
Day 7, 15 Minutes Post Conjunctival Allergen Challenge	1.41 ± 1.048	1.36 ± 1.099
Day 7, 20 Minutes Post Conjunctival Allergen Challenge	1.24 ± 0.987	1.22 ± 1.072
Day 7, 25 Minutes Post Conjunctival Allergen Challenge	1.15 ± 0.989	1.22 ± 1.174
Day 7, 30 Minutes Post Conjunctival Allergen Challenge	1.12 ± 1.008	1.17 ± 1.159
Day 8, pre-Conjunctival Allergen Challenge	0.47 ± 0.662	0.33 ± 0.717
Day 8, 10 Minutes Post Conjunctival Allergen Challenge	1.29 ± 1.060	1.36 ± 1.199
Day 8, 15 Minutes Post Conjunctival Allergen Challenge	1.35 ± 1.070	1.39 ± 1.293
Day 8, 20 Minutes Post Conjunctival Allergen Challenge	1.26 ± 1.024	1.28 ± 1.279
Day 8, 25 Minutes Post Conjunctival Allergen Challenge	1.18 ± 0.968	1.28 ± 1.210
Day 8, 30 Minutes Post Conjunctival Allergen Challenge	1.15 ± 1.048	1.22 ± 1.222

Statistical analysis

Group 1 vs Group 2 · ANCOVA · p = 0.8818 (Adjustments for multiplicity were not employed)
Group 1 vs Group 2 · ANCOVA · p = 0.8679 (Adjustments for multiplicity were not employed)
Group 1 vs Group 2 · ANCOVA · p = 0.7856 (Adjustments for multiplicity were not employed)
Group 1 vs Group 2 · ANCOVA · p = 0.7507 (Adjustments for multiplicity were not employed)
Group 1 vs Group 2 · ANCOVA · p = 0.8189 (Adjustments for multiplicity were not employed)
Group 1 vs Group 2 · ANCOVA · p = 0.9206 (Adjustments for multiplicity were not employed)
Group 1 vs Group 2 · ANCOVA · p = 0.9591 (Adjustments for multiplicity were not employed)
Group 1 vs Group 2 · ANCOVA · p = 0.5302 (Adjustments for multiplicity were not employed)
Group 1 vs Group 2 · ANCOVA · p = 0.7591 (Adjustments for multiplicity were not employed)
Group 1 vs Group 2 · ANCOVA · p = 0.8978 (Adjustments for multiplicity were not employed)
Group 1 vs Group 2 · ANCOVA · p = 0.7179 (Adjustments for multiplicity were not employed)
Group 1 vs Group 2 · ANCOVA · p = 0.7262 (Adjustments for multiplicity were not employed)
Group 1 vs Group 2 · ANCOVA · p = 0.8275 (Adjustments for multiplicity were not employed)
Group 1 vs Group 2 · ANCOVA · p = 0.6180 (Adjustments for multiplicity were not employed)

SecondaryNasal Composite Score

A composite score of presence or absence of at least one nasal symptom evaluated by the subject

Time frame:: Day 7 and 8
Reported as:: Count of participants · Participants

Nasal Composite Score
Participants	Group 1	Group 2
Day 7, Pre-Conjunctival Allergen Challenge — Absent	11	23
Day 7, Pre-Conjunctival Allergen Challenge — PResent	22	13
Day 7, 10 Minutes Post Conjunctival Allergen Challenge — Absent	2	2
Day 7, 10 Minutes Post Conjunctival Allergen Challenge — PResent	32	34
Day 7, 15 Minutes Post Conjunctival Allergen Challenge — Absent	2	2
Day 7, 15 Minutes Post Conjunctival Allergen Challenge — PResent	32	34
Day 7, 20 Minutes Post Conjunctival Allergen Challenge — Absent	3	3
Day 7, 20 Minutes Post Conjunctival Allergen Challenge — PResent	31	33
Day 7, 25 Minutes Post Conjunctival Allergen Challenge — Absent	5	4
Day 7, 25 Minutes Post Conjunctival Allergen Challenge — PResent	29	32
Day 7, 30 Minutes Post Conjunctival Allergen Challenge — Absent	4	4
Day 7, 30 Minutes Post Conjunctival Allergen Challenge — PResent	30	32
Day 8, pre-Conjunctival Allergen Challenge — Absent	18	26
Day 8, pre-Conjunctival Allergen Challenge — PResent	16	10
Day 8, 10 Minutes Post Conjunctival Allergen Challenge — Absent	1	2
Day 8, 10 Minutes Post Conjunctival Allergen Challenge — PResent	33	34
Day 8, 15 Minutes Post Conjunctival Allergen Challenge — Absent	2	3
Day 8, 15 Minutes Post Conjunctival Allergen Challenge — PResent	32	33
Day 8, 20 Minutes Post Conjunctival Allergen Challenge — Absent	4	4
Day 8, 20 Minutes Post Conjunctival Allergen Challenge — PResent	30	32
Day 8, 25 Minutes Post Conjunctival Allergen Challenge — Absent	2	5
Day 8, 25 Minutes Post Conjunctival Allergen Challenge — PResent	32	31
Day 8, 30 Minutes Post Conjunctival Allergen Challenge — Absent	3	6
Day 8, 30 Minutes Post Conjunctival Allergen Challenge — PResent	31	30

Statistical analysis

Group 1 vs Group 2 · Fisher Exact · p = >0.9999 (Adjustments for multiplicity were not employed)
Group 1 vs Group 2 · Fisher Exact · p = >0.9999 (Adjustments for multiplicity will not be employed)
Group 1 vs Group 2 · Fisher Exact · p = >0.9999 (Adjustments for multiplicity will not be employed)
Group 1 vs Group 2 · Fisher Exact · p = 0.7312 (Adjustments for multiplicity will not be employed)
Group 1 vs Group 2 · Fisher Exact · p = >0.9999 (Adjustments for multiplicity will not be employed)
Group 1 vs Group 2 · Fisher Exact · p = >0.9999 (Adjustments for multiplicity will not be employed)
Group 1 vs Group 2 · Fisher Exact · p = >0.9999 (Adjustments for multiplicity will not be employed)
Group 1 vs Group 2 · Fisher Exact · p = >0.9999 (Adjustments for multiplicity will not be employed)
Group 1 vs Group 2 · Fisher Exact · p = 0.4297 (Adjustments for multiplicity will not be employed)
Group 1 vs Group 2 · Fisher Exact · p = 0.4791 (Adjustments for multiplicity will not be employed)

Adverse events

Collected over Adverse events were assessed for subjects over a period of 8 days during active treatment. If an AE was unresolved at the final study visit Investigators were instructed to follow-up with subjects until the AE resolved or they were lost to follow-up. If the patient is lost to follow-up, the Investigator should make 3 reasonable attempts to contact the patient via telephone, post, or certified mail.. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Group 1	0/34 (0%)	0/34 (0%)	2/34 (5.9%)
Group 2	0/36 (0%)	0/36 (0%)	3/36 (8.3%)

Most frequent other events

Most frequent other events
Event	Group 1	Group 2
HeadacheNervous system disorders	0/34	3/36
Visual Acuity ReducedEye disorders	1/34	0/36
Infected BiteInfections and infestations	1/34	0/36

Baseline characteristics

Age, Continuous
Age, Continuous(years)	Group 1	Group 2	Total
Mean	43.5 ± 13.44	47 ± 13.98	45.3 ± 13.74

Sex: Female, Male
Sex: Female, Male(Participants)	Group 1	Group 2	Total
Female	19	22	41
Male	15	14	29

Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)	Group 1	Group 2	Total
Hispanic or Latino	4	4	8
Not Hispanic or Latino	30	32	62
Unknown or Not Reported	0	0	0

Race (NIH/OMB)
Race (NIH/OMB)(Participants)	Group 1	Group 2	Total
American Indian or Alaska Native	0	0	0
Asian	0	1	1
Native Hawaiian or Other Pacific Islander	0	1	1
Black or African American	9	10	19
White	25	24	49
More than one race	0	0	0
Unknown or Not Reported	0	0	0

Iris Color
Iris Color(eyes)	Group 1	Group 2	Total
Black	0	0	0
Blue	10	20	30
Brown	42	44	86
Hazel	8	2	10
Green	8	6	14
Other	0	0	0

Allergen Disposition
Allergen Disposition(Participants)	Group 1	Group 2	Total
Dust Mite	18	16	34
Dog Dander	4	5	9
Cockroach	1	4	5
Cat Dander	11	11	22

Study locations

2 sites

Andover, Massachusetts 01810, United States
Memphis, Tennessee 38119, United States

References and documents

Study documents

Study protocol ↗ · Jan 13, 2017
Statistical analysis plan ↗ · Jan 5, 2017

PDFs hosted by the registry, ClinicalTrials.gov.

Individual participant data

Plan to share: Undecided

Timeline

Tracking since Sep 25, 2026

ElapsedEstimatedEstimated, not yet reached

Ran from Dec 2016 to primary completion in Feb 2017, 2 months.

Results were first posted in Sep 2021, 4 years 7 months after primary completion. A results delay was requested in Sep 2018.

How these figures are worked out, and which studies are left out of them.

Registered: Nov 28, 2016
First posted: Nov 30, 2016
StartActual: Dec 2016
Primary completionActual: Feb 2017
CompletionActual: Nov 2017
Results delay requested: Sep 24, 2018
Results first posted: Sep 16, 2021
Last update: Apr 10, 2023

What these dates mean

Start.: When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.: When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.: When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.: Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.

No changes since tracking began. The registry record was last updated on Apr 10, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT02978183
Lead sponsor: Noveome Biotherapeutics, formerly Stemnion
Responsible party: Sponsor
First posted: Nov 30, 2016
Start date: Dec 2016
Primary completion: Feb 2017
Completion: Nov 2017
Results posted: Sep 16, 2021
Last update: Apr 10, 2023

Oversight

Data monitoring committee: No

View the source record on ClinicalTrials.gov ↗

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Studies of the drug tested here: ST266

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Conjunctivitis, Allergic →

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Noveome Biotherapeutics, formerly Stemnion

Start the discussion

Evaluation of the Effectiveness of ST266 Ophthalmic Drops Compared to Placebo to Treat Allergic Conjunctivitis

Study summary

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