CompletedNCT02578914Updated Dec 5, 2023Results posted

A Safety and Activity Study of NS2 in Subjects With Allergic Conjunctivitis

A Phase 2 interventional study of NS2 Ophthalmic Drops (0.5%) and NS2 Ophthalmic Drops Vehicle (0.0%) in Allergic Conjunctivitis and Seasonal Allergies, sponsored by Aldeyra Therapeutics, Inc.. Completed at 1 site in Canada. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-12-05.

Sponsored by Aldeyra Therapeutics, Inc. · Phase 2, Interventional, and Treatment

Phase: Phase 2
Study type: Interventional
Enrollment: 100
Allocation: Randomized
Ages: 18 Years and older
Sex: All

Study summary

This is a randomized, parallel, single center, double masked, vehicle controlled study. The purpose of this study is to determine the activity and safety of NS2 in patients with grass, tree or ragweed-pollen induced seasonal allergic conjunctivitis . Subjects will be randomized 1:1 to receive multiple doses of NS2 Ophthalmic Drops (0.5%) or NS2 Ophthalmic Drops Vehicle (0.0%).

Free aldehydes are thought to be related to inflammatory conditions such as allergic conjunctivitis. NS2, a small molecule aldehyde trap, is being evaluated to determine whether it may decrease inflammation by lowering aldehyde levels.

Conditions studied

Allergic Conjunctivitis
Seasonal Allergies

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Keywords

allergic conjunctivitis
seasonal allergies
ragweed allergy
grass allergy
tree allergy
NS2
Aldeyra

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 100 is above the median of 87 across 174 interventional studies indexed under Conjunctivitis, Allergic.

Browse Conjunctivitis, Allergic studies →

Lead sponsor

Aldeyra Therapeutics, Inc. is the lead sponsor of 35 studies on the registry; 1 is open to participants now.

Of its 29 completed or terminated interventional studies of FDA-regulated products, 25 (86%) have results posted.

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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

Graded conjunctival redness in at least one region (nasal or temporal) in each eye at any one time point (not necessarily the same time point) post-CAPT (Conjunctival Allergen Provocation Test) of >2
Graded ocular itching at any one time point
Visual acuity of at least 20/50 in each eye
At least 2 year history of moderate to severe allergic conjunctivitis.
Positive skin prick test to ragweed, grass and/or tree pollen within one year of Screening Visit (Visit 1).
Ability to avoid any topical or systemic ocular medications during the entire study period.

Exclusion criteria

Exclusion Criteria:

Subjects must not have an ocular itching score >0 or a conjunctival redness score >1 prior to CAPT in either eye in any region (nasal or temporal) at Visits 2-4. I
History of glaucoma, or Intraocular Pressure (IOP) over 25mmHg at the screening visit, or a history of elevated IOP within the past 1 year.
Ocular surgery, including laser procedures, within the past 12 months of Visit 1.
Use of glaucoma medications, antibiotics, antivirals, or topical cyclosporine within 1 month of the screening visit.
History of dry eye syndrome, blepharitis, herpes simplex keratitis or herpes zoster keratitis.
History of uveitis in the past 3 years.
Presence of any ocular infection or active ocular inflammation (e.g. follicular conjunctivitis, allergic conjunctivitis) within 14 days prior to start of study (Visit 1).
History of moderate to severe asthma or allergy induced asthma to the allergen that will be used in CAPT.
Use of oral within 30 days of screening and throughout the study period; use of intranasal or inhaled corticosteroids within 14 days of screening and throughout the study period.
Use of antihistamines (ocular, nasal, topical or oral) within 7 days prior to screening (Visit 1) and throughout the study period. Non-medicated artificial tears are allowed up to 72 hours before screening (Visit 1) and throughout the study period.

Terms in these criteria, in plain language(1)

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.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

Study design

Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment: 100 participants (actual)

Study arms

Experimental
NS2 Ophthalmic Drops (0.5%)
NS2 Ophthalmic Drops (0.5%)
Drug: NS2 Ophthalmic Drops (0.5%)
Sham comparator
NS2 Ophthalmic Drops Vehicle (0.0%)
NS2 Ophthalmic Drops Vehicle (0.0%) control
Drug: NS2 Ophthalmic Drops Vehicle (0.0%)

Interventions

DrugNS2 Ophthalmic Drops (0.5%)
DrugNS2 Ophthalmic Drops Vehicle (0.0%)

What researchers measure

Primary outcomes

Ocular Itching Score at Day 14, 60 Minutes Into the Allergen Challenge
Mean change from baseline in ocular itching score using a 0 to 4 scale (0 = none, 4 = severe) on Day 14, 60 minutes into the allergen challenge. The least squares mean (standard error) was derived from analysis of covariance (ANCOVA) with baseline as a covariate and treatment group as a factor.
Time frame: The efficacy assessment period was assessed at Day 14; baseline was Day -7.

Results

Posted Dec 5, 2023

Participant flow

Participant flow — Overall Study
Milestone	NS2 Ophthalmic Drops (0.5%)	Vehicle Ophthalmic Drops
Started	50	50
Completed	48	50
Not completed	2	0

Outcome measures

PrimaryOcular Itching Score at Day 14, 60 Minutes Into the Allergen Challenge

Mean change from baseline in ocular itching score using a 0 to 4 scale (0 = none, 4 = severe) on Day 14, 60 minutes into the allergen challenge. The least squares mean (standard error) was derived from analysis of covariance (ANCOVA) with baseline as a covariate and treatment group as a factor.

Time frame:: The efficacy assessment period was assessed at Day 14; baseline was Day -7.
Reported as:: Least squares mean · units on a scale

Ocular Itching Score at Day 14, 60 Minutes Into the Allergen Challenge
units on a scale	NS2 Ophthalmic Drops (0.5%)	Vehicle Ophthalmic Drops
Ocular Itching Score at Day 14, 60 Minutes Into the Allergen Challenge	-1.550 ± 0.168	-1.013 ± 0.163

Adverse events

Collected over The period of time over which adverse events were collected for each subject was approximately 9 weeks.. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
NS2 Ophthalmic Drops (0.5%)	0/50 (0%)	0/50 (0%)	49/50 (98%)
Vehicle Ophthalmic Drops	0/50 (0%)	0/50 (0%)	11/50 (22%)

Most frequent other events

Most frequent other events
Event	NS2 Ophthalmic Drops (0.5%)	Vehicle Ophthalmic Drops
General disorders and administration site conditionsGeneral disorders	49/50	4/50
HeadacheNervous system disorders	6/50	5/50
Lacrimination increasedEye disorders	3/50	0/50
Punctate keratitisEye disorders	3/50	2/50

Baseline characteristics

Age, Continuous
Age, Continuous(years)	NS2 Ophthalmic Drops (0.5%)	Vehicle Ophthalmic Drops	Total
Mean	45.1 ± 12.5	41.9 ± 12.1	43.5 ± 12.4

Sex: Female, Male
Sex: Female, Male(Participants)	NS2 Ophthalmic Drops (0.5%)	Vehicle Ophthalmic Drops	Total
Female	32	24	56
Male	18	26	44

Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)	NS2 Ophthalmic Drops (0.5%)	Vehicle Ophthalmic Drops	Total
Hispanic or Latino	5	5	10
Not Hispanic or Latino	45	45	90
Unknown or Not Reported	0	0	0

Race/Ethnicity, Customized
Race/Ethnicity, Customized(Participants)	NS2 Ophthalmic Drops (0.5%)	Vehicle Ophthalmic Drops	Total
American Indian or Alaska Native	0	0	0
Asian	13	9	22
Black or African American	11	8	19
Native Hawaiian / other Pacific Islander	0	0	0
White	22	30	52
Other	4	3	7

Region of Enrollment
Region of Enrollment(Participants)	NS2 Ophthalmic Drops (0.5%)	Vehicle Ophthalmic Drops	Total
Canada	50	50	100

Study locations

1 site

Inflamax Research Inc.
Mississauga, Ontario L4W 1A4, Canada

Timeline

Tracking since Sep 25, 2026

Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Aug 2015, a primary completion of Dec 2015 and a completion of Dec 2015. It does not say whether these dates are actual or estimated.

Results were first posted in Dec 2023, 8 years after primary completion.

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

Registered: Oct 8, 2015
First posted: Oct 19, 2015
Start: Aug 2015
Primary completionActual: Dec 2015
CompletionActual: Dec 2015
Results first posted: Dec 5, 2023
Last update: Dec 5, 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 Dec 5, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT02578914
Lead sponsor: Aldeyra Therapeutics, Inc.
Responsible party: Sponsor
First posted: Oct 19, 2015
Start date: Aug 2015
Primary completion: Dec 2015
Completion: Dec 2015
Results posted: Dec 5, 2023
Last update: Dec 5, 2023

Study contacts

Peter Couroux

principal investigator · Inflamax Research Incorporated

Oversight

Data monitoring committee: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2016. You cannot join it, but the record below documents what was studied.

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