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CompletedNCT05314621Updated Sep 2, 2022

A Study Comparing the Efficacy of Pataday® Once Daily Relief Extra Strength to Flonase® Allergy Relief in Subjects With Allergic Conjunctivitis

A Phase 4 interventional study of olopatadine hydrochloride ophthalmic solution 0.7%) and Fluticasone Propionate in Allergic Conjunctivitis, sponsored by Andover Research Eye Institute. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-09-02.

Sponsored by Andover Research Eye Institute · Phase 4, Interventional, and Treatment

From the registry’s dates

  • Primary completion was Jul 2022, 4 years 3 months ago, and no results have been posted to the registry.
Phase
Phase 4
Study type
Interventional
Enrollment
61
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

This is a single-center, randomized, double-masked, parallel study.

Read the detailed description

At Visit 1, subjects will sign the informed consent and an allergic skin test will be performed, if required. Each qualifying subject will undergo a bilateral conjunctival allergen challenge (Ora-CAC®) titration using an allergen they had a positive reaction to on their skin test. Subjects who elicit a positive reaction post-CAC will undergo the confirmation CAC at Visit 2 using the same allergen they qualified with at Visit 1.

For subjects who continue to qualify following the confirmation CAC, treatment will begin at Visit 3. Subjects will be randomized to receive the following treatment at a 1:1 ratio:

  • Pataday® Once Daily Relief Extra Strength and Saline Nasal Spray (n = 30)
  • Tears Naturale® II and Flonase® Allergy Relief (n = 30)

At Visit 3, subjects will receive in-office administration of the assigned treatment. A trained study technician will observe subjects self-administer one drop of the assigned eyedrop (Pataday® Once Daily Relief Extra Strength or Tears Naturale® II) bilaterally. Within 5 minutes of administration of the eyedrop, a trained study technician will observe the subject self-administer two sprays of the assigned nasal spray (Flonase® Allergy Relief or saline nasal spray) in each nostril. Subjects will then undergo CAC 15 minutes following administration of the assigned nasal spray. Subjects will be dispensed the assigned study treatment to be used once daily beginning the day after Visit 3 up until the day before Visit 4 (Day 2 through Day 14). Subjects will also be dispensed a diary to record their daily dosing.

At Visit 4a, subjects will receive in-office administration of the assigned treatment. A trained study technician will observe subjects self-administer one drop of the assigned eyedrop (Pataday® Once Daily Relief Extra Strength or Tears Naturale® II) bilaterally. Within 5 minutes of administration of the eyedrop, a trained study technician will observe the subject self-administer two sprays of the assigned nasal spray (Flonase® Allergy Relief or saline nasal spray) in each nostril. Subjects will then return the next day for Visit 4b and will undergo CAC 24 hours following administration of the assigned nasal spray at Visit 4a.

02

Conditions studied

  • Allergic Conjunctivitis
03

In context

Conjunctivitis, Allergic

231 studies on the registry are indexed under Conjunctivitis, Allergic; 19 are open to participants now.

This study's enrollment of 61 is below the median of 85 across 192 interventional studies indexed under Conjunctivitis, Allergic.

Browse Conjunctivitis, Allergic studies →

Lead sponsor

Andover Research Eye Institute is the lead sponsor of 3 studies on the registry; 1 is open to participants now.

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

04

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

  1. Be at least 18 years of age at Visit 1 of either gender and any race;
  2. Provide written informed consent and sign the HIPAA form;
  3. Be willing and able to follow all instructions and attend all study visits;
  4. Be able to self-administer eyedrops and nasal spray satisfactorily or have a caregiver at home routinely available for this purpose;
  5. Have a history of ocular allergies and a positive skin test reaction to a seasonal (grass, ragweed, and/or tree pollen) or perennial (cat dander, dog dander, dust mites, cockroach) allergen as confirmed by an allergic skin test conducted at Visit 1 or within the last 24 months;
  6. Be able and willing to avoid all disallowed medications for the appropriate washout period and during the study (see exclusion 6);
  7. Be able and willing to discontinue wearing contact lenses for at least 72 hours prior to Visit 1 and during the study trial period;
  8. (for females capable of becoming pregnant) agree to have urine pregnancy testing performed at screening (must be negative) and exit visit; must not be lactating; and must agree to use a medically acceptable form of birth control throughout the study duration. 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);
  9. Have a calculated best-corrected visual acuity of 0.7 logMAR or better in each eye as measured using an ETDRS chart;
  10. Have a positive bilateral post-CAC reaction (defined as having scores of ≥2 ocular itching and ≥2 conjunctival redness) within 10 (±2) minutes of instillation of the last titration of allergen at Visit 1;
  11. Have a positive bilateral post-CAC reaction (defined as having scores of ≥2 ocular itching and ≥2 conjunctival redness) for at least two out of the first three time points following the challenge at Visit 2.

Exclusion criteria

Exclusion Criteria:

  1. Have known contraindications or sensitivities to the use of the investigational product or any of its components;
  2. 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, clinically significant blepharitis, follicular conjunctivitis, iritis, pterygium, history of corneal transplantation or a diagnosis of dry eye);
  3. Have had ocular surgical intervention within three (3) months prior to Visit 1 or during the study and/or a history of refractive surgery within the past six (6) months;
  4. Have a known history of retinal detachment, diabetic retinopathy, or active retinal disease;
  5. Have the presence of an active ocular infection (bacterial, viral, or fungal) or positive history of an ocular herpetic infection at any visit;
  6. Use any of the following disallowed medications during the period indicated prior to Visit 1 and during the study:

7 Days

  • systemic or ocular H1-antihistamine, H1-antihistamine/mast cell stabilizers, H1-antihistamine-vasoconstrictor drug combinations;
  • decongestants;
  • monoamine oxidase inhibitors
  • all other topical ophthalmic preparations (including artificial tears)
  • lid scrubs;
  • topical prostaglandins or prostaglandin derivatives
  • ocular, topical, or systemic nonsteroidal anti-inflammatory drugs (NSAIDs, including baby aspirin (81 mg)) 14 Days
  • inhaled, ocular, topical, or systemic corticosteroids or mast cell stabilizers
  • ritonavir or other potent cytochrome P450 3A4 inhibitors; 45 Days

  • depo-corticosteroids; Note: Currently marketed over-the-counter anti-allergy eye drops (i.e. anti-histamine/vasoconstrictor combination products such as Visine®-A®) may be administered to subjects by trained study personnel at the end of Visits 1, 2 and 4b after all evaluations are completed.

    7. Have any significant illness (e.g. any autoimmune 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;

    8. Have received allergy immunotherapy within the last 2 years;

    9. Manifest signs or symptoms of clinically active allergic conjunctivitis in either eye at the start of Visits 1, 2, or 3 (defined as the presence of any itching or >1 [greater than 1] redness in any vessel bed);

    10. Have a history of glaucoma;

    11. Have planned surgery (ocular or systemic) during the trial period or within 30 days after;

    12. Have used an investigational drug or medical device within 30 days of the study or be concurrently enrolled in another investigational product trial;

    13. Be a female who is currently pregnant, planning a pregnancy, or lactating.

05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
61 participants (actual)

Study arms

  • Active comparator
    Pataday® Once Daily Relief Extra Strength and Saline Nasal Spray

    Pataday® Once Daily Relief Extra Strength (olopatadine hydrochloride ophthalmic solution 0.7%) will be administered bilaterally and saline nasal spray will be administered nasally (within 5 minutes of eyedrop) at Visits 3 and 4a.

    Drug: olopatadine hydrochloride ophthalmic solution 0.7%) · Drug: Saline nasal spray

  • Active comparator
    Tears Naturale® II and Flonase® Allergy Relief

    Tears Naturale® II will be administered bilaterally and Flonase® Allergy Relief (fluticasone propionate) will be administered nasally (within 5 minutes of eyedrop) at Visits 3 and 4a.

    Drug: Fluticasone Propionate · Drug: Tears Naturale

Interventions

  • Drugolopatadine hydrochloride ophthalmic solution 0.7%)

    Pataday® Once Daily Relief Extra Strength (eyedrop)

    Also known as: Pataday® Once Daily Relief Extra Strength

  • DrugFluticasone Propionate

    Flonase® Allergy Relief (nasal spray)

    Also known as: Flonase® Allergy Relief

  • DrugTears Naturale

    Tears Naturale® II (eye drop)

    Also known as: Tears Naturale® II

  • DrugSaline nasal spray

    Saline nasal spray (nasal spray)

06

What researchers measure

Primary outcomes

  1. Ocular itching 3(±1) minutes post-CAC at Visit 3

    Ocular itching evaluated by the subject at 3(±1) minutes post-CAC (0-4 on the Ocular Itching scale with 4 being the worst, allowing half unit increments) at Visit 3.

    Time frame: 3(±1) minutes post-CAC on Day 1 (Visit 3)

  2. Ocular itching 3(±1) minutes post-CAC at Visit 4b

    Ocular itching evaluated by the subject at 3(±1) minutes post-CAC (0-4 on the Ocular Itching scale with 4 being the worst, allowing half unit increments) at Vi sit 4b.

    Time frame: 3(±1) minutes post-CAC at Visit 4b (24 hours from Visit 4a; Day 15±3)

  3. Ocular itching 5(±1) minutes post-CAC at Visit 3

    Ocular itching evaluated by the subject at 5(±1) minutes post-CAC (0-4 on the Ocular Itching scale with 4 being the worst, allowing half unit increments) at Visit 3.

    Time frame: 5(±1) minutes post-CAC on Day 1 (Visit 3)

  4. Ocular itching 5(±1) minutes post-CAC at Visit 4b

    Ocular itching evaluated by the subject at 5(±1) minutes post-CAC (0-4 on the Ocular Itching scale with 4 being the worst, allowing half unit increments) at Visit 4b.

    Time frame: 5(±1) minutes post-CAC at Visit 4b (24 hours from Visit 4a; Day 15±3)

  5. Ocular itching 7(±1) minutes post-CAC at Visit 3

    Ocular itching evaluated by the subject at 7(±1) minutes post-CAC (0-4 on the Ocular Itching scale with 4 being the worst, allowing half unit increments) at Visit 3.

    Time frame: 7(±1) minutes post-CAC on Day 1 (Visit 3)

  6. Ocular itching 7(±1) minutes post-CAC at Visit 4b

    Ocular itching evaluated by the subject at 7(±1) minutes post-CAC (0-4 on the Ocular Itching scale with 4 being the worst, allowing half unit increments) at Visit 4b.

    Time frame: 7(±1) minutes post-CAC at Visit 4b (24 hours from Visit 4a; Day 15±3)

Secondary outcomes

  1. Secondary Efficacy Measures 7(±1) minutes post-CAC at Visit 3; Conjunctival Redness

    Conjunctival redness evaluated by the investigator (0-4 on the Ocular Redness scale with 4 being the worst, allowing half unit increments) at Visit 3. Conjunctival redness evaluated by the investigator (0-4 on the Ocular Redness scale with 4 being the worst, allowing half unit increments) at Visit 3. Conjunctival redness evaluated by the investigator (0-4 on the Ocular Redness scale with 4 being the worst, allowing half unit increments) at Visit 3.

    Time frame: 7(±1) minutes post-CAC on Day 1 (Visit 3)

  2. Secondary Efficacy Measures 15(±1) minutes post-CAC at Visit 3; Conjunctival Redness

    Conjunctival redness evaluated by the investigator (0-4 on the Ocular Redness scale with 4 being the worst, allowing half unit increments) at Visit 3.

    Time frame: 15(±1) minutes post-CAC on Day 1 (Visit 3)

  3. Secondary Efficacy Measures 20(±1) minutes post-CAC at Visit 3; Conjunctival Redness

    Conjunctival redness evaluated by the investigator (0-4 on the Ocular Redness scale with 4 being the worst, allowing half unit increments) at Visit 3.

    Time frame: 20(±1) minutes post-CAC on Day 1 (Visit 3)

  4. Secondary Efficacy Measures 7(±1) minutes post-CAC at Visit 3; Ciliary Redness

    Ciliary redness evaluated by the investigator (0-4 on the Ocular Redness scale with 4 being the worst, allowing half unit increments) at Visit 3.

    Time frame: 7(±1) minutes post-CAC on Day 1 (Visit 3)

  5. Secondary Efficacy Measures 15(±1) minutes post-CAC at Visit 3; Ciliary Redness

    Ciliary redness evaluated by the investigator (0-4 on the Ocular Redness scale with 4 being the worst, allowing half unit increments) at Visit 3.

    Time frame: 15(±1) minutes post-CAC on Day 1 (Visit 3)

  6. Secondary Efficacy Measures 20(±1) minutes post-CAC at Visit 3; Ciliary Redness

    Ciliary redness evaluated by the investigator (0-4 on the Ocular Redness scale with 4 being the worst, allowing half unit increments) at Visit 3.

    Time frame: 20(±1) minutes post-CAC on Day 1 (Visit 3)

  7. Secondary Efficacy Measures 7(±1) minutes post-CAC at Visit 3; Episcleral Redness

    Episcleral redness evaluated by the investigator (0-4 on the Ocular Redness scale with 4 being the worst, allowing half unit increments) at Visit 3.

    Time frame: 7(±1) minutes post-CAC on Day 1 (Visit 3)

  8. Secondary Efficacy Measures 15(±1) minutes post-CAC at Visit 3; Episcleral Redness

    Episcleral redness evaluated by the investigator (0-4 on the Ocular Redness scale with 4 being the worst, allowing half unit increments) at Visit 3.

    Time frame: 15(±1) minutes post-CAC on Day 1 (Visit 3)

  9. Secondary Efficacy Measures 20(±1) minutes post-CAC at Visit 3; Episcleral Redness

    Episcleral redness evaluated by the investigator (0-4 on the Ocular Redness scale with 4 being the worst, allowing half unit increments) at Visit 3. Episcleral redness evaluated by the investigator (0-4 on the Ocular Redness scale with 4 being the worst, allowing half unit increments) at Visit 3. Episcleral redness evaluated by the investigator (0-4 on the Ocular Redness scale with 4 being the worst, allowing half unit increments) at Visit 3.

    Time frame: 20(±1) minutes post-CAC on Day 1 (Visit 3)

  10. Secondary Efficacy Measures 7(±1) minutes post-CAC at Visit 3; Chemosis

    Chemosis evaluated by the investigator (0-4 on the Ocular Chemosis scale with 4 being the worst, allowing half unit increments) at Visit 3.

    Time frame: 7(±1) minutes post-CAC on Day 1 (Visit 3)

  11. Secondary Efficacy Measures 15(±1) minutes post-CAC at Visit 3; Chemosis

    Chemosis evaluated by the investigator (0-4 on the Ocular Chemosis scale with 4 being the worst, allowing half unit increments) at Visit 3.

    Time frame: 15(±1) minutes post-CAC on Day 1 (Visit 3)

  12. Secondary Efficacy Measures 20(±1) minutes post-CAC at Visit 3; Chemosis

    Chemosis evaluated by the investigator (0-4 on the Ocular Chemosis scale with 4 being the worst, allowing half unit increments) at Visit 3.

    Time frame: 20(±1) minutes post-CAC on Day 1 (Visit 3)

  13. Secondary Efficacy Measures 7(±1) minutes post-CAC at Visit 3; Eyelid Swelling

    Eyelid swelling evaluated by the subject (0-3 on the Eyelid Swelling scale with 3 being the worst, not allowing half unit increments) at Visit 3.

    Time frame: 7(±1) minutes post-CAC on Day 1 (Visit 3)

  14. Secondary Efficacy Measures 15(±1) minutes post-CAC at Visit 3; Eyelid Swelling

    Eyelid swelling evaluated by the subject (0-3 on the Eyelid Swelling scale with 3 being the worst, not allowing half unit increments) at Visit 3.

    Time frame: 15(±1) minutes post-CAC on Day 1 (Visit 3)

  15. Secondary Efficacy Measures 20(±1) minutes post-CAC at Visit 3; Eyelid Swelling

    Eyelid swelling evaluated by the subject (0-3 on the Eyelid Swelling scale with 3 being the worst, not allowing half unit increments) at Visit 3.

    Time frame: 20(±1) minutes post-CAC on Day 1 (Visit 3)

  16. Secondary Efficacy Measures 7(±1) minutes post-CAC at Visit 3; Tearing

    Tearing evaluated by the subject (0-4 on the Tearing scale with 4 being the worst, not allowing half unit increments) at Visit 3.

    Time frame: 7(±1) minutes post-CAC on Day 1 (Visit 3)

  17. Secondary Efficacy Measures 15(±1) minutes post-CAC at Visit 3; Tearing

    Tearing evaluated by the subject (0-4 on the Tearing scale with 4 being the worst, not allowing half unit increments) at Visit 3.

    Time frame: 15(±1) minutes post-CAC on Day 1 (Visit 3)

  18. Secondary Efficacy Measures 20(±1) minutes post-CAC at Visit 3; Tearing

    Tearing evaluated by the subject (0-4 on the Tearing scale with 4 being the worst, not allowing half unit increments) at Visit 3.

    Time frame: 20(±1) minutes post-CAC on Day 1 (Visit 3)

  19. Secondary Efficacy Measures 7(±1) minutes post-CAC at Visit 3; Rhinorrhea

    Rhinorrhea evaluated by the subject (0-4 on the Rhinorrhea scale with 4 being the worst, not allowing half unit increments) at Visit 3.

    Time frame: 7(±1) minutes post-CAC on Day 1 (Visit 3)

  20. Secondary Efficacy Measures 15(±1) minutes post-CAC at Visit 3; Rhinorrhea

    Rhinorrhea evaluated by the subject (0-4 on the Rhinorrhea scale with 4 being the worst, not allowing half unit increments) at Visit 3.

    Time frame: 15(±1) minutes post-CAC on Day 1 (Visit 3)

  21. Secondary Efficacy Measures 20(±1) minutes post-CAC at Visit 3; Rhinorrhea

    Rhinorrhea evaluated by the subject (0-4 on the Rhinorrhea scale with 4 being the worst, not allowing half unit increments) at Visit 3.

    Time frame: 20(±1) minutes post-CAC on Day 1 (Visit 3)

  22. Secondary Efficacy Measures 7(±1) minutes post-CAC at Visit 3; Nasal Pruritis

    Nasal pruritis evaluated by the subject (0-4 on the Nasal Pruritis scale with 4 being the worst, not allowing half unit increments) at Visit 3.

    Time frame: 7(±1) minutes post-CAC on Day 1 (Visit 3)

  23. Secondary Efficacy Measures 15(±1) minutes post-CAC at Visit 3; Nasal Pruritis

    Nasal pruritis evaluated by the subject (0-4 on the Nasal Pruritis scale with 4 being the worst, not allowing half unit increments) at Visit 3.

    Time frame: 15(±1) minutes post-CAC on Day 1 (Visit 3)

  24. Secondary Efficacy Measures 20(±1) minutes post-CAC at Visit 3; Nasal Pruritis

    Nasal pruritis evaluated by the subject (0-4 on the Nasal Pruritis scale with 4 being the worst, not allowing half unit increments) at Visit 3.

    Time frame: 20(±1) minutes post-CAC on Day 1 (Visit 3)

  25. Secondary Efficacy Measures 7(±1) minutes post-CAC at Visit 3; Ear or Palate Pruritis

    Ear or palate pruritis evaluated by the subject (0-4 on the Ear or Palate Pruritis scale with 4 being the worst, not allowing half unit increments) at Visit 3.

    Time frame: 7(±1) minutes post-CAC on Day 1 (Visit 3)

  26. Secondary Efficacy Measures 15(±1) minutes post-CAC at Visit 3; Ear or Palate Pruritis

    Ear or palate pruritis evaluated by the subject (0-4 on the Ear or Palate Pruritis scale with 4 being the worst, not allowing half unit increments) at Visit 3.

    Time frame: 15(±1) minutes post-CAC on Day 1 (Visit 3)

  27. Secondary Efficacy Measures 20(±1) minutes post-CAC at Visit 3; Ear or Palate Pruritis

    Ear or palate pruritis evaluated by the subject (0-4 on the Ear or Palate Pruritis scale with 4 being the worst, not allowing half unit increments) at Visit 3.

    Time frame: 20(±1) minutes post-CAC on Day 1 (Visit 3)

  28. Secondary Efficacy Measures 7(±1) minutes post-CAC at Visit 3; Nasal Congestion

    Nasal congestion evaluated by the subject (0-4 on the Nasal Congestion scale with 4 being the worst, not allowing half unit increments) at Visit 3.

    Time frame: 7(±1) minutes post-CAC on Day 1 (Visit 3)

  29. Secondary Efficacy Measures 15(±1) minutes post-CAC at Visit 3; Nasal Congestion

    Nasal congestion evaluated by the subject (0-4 on the Nasal Congestion scale with 4 being the worst, not allowing half unit increments) at Visit 3.

    Time frame: 15(±1) minutes post-CAC on Day 1 (Visit 3)

  30. Secondary Efficacy Measures 20(±1) minutes post-CAC at Visit 3; Nasal Congestion

    Nasal congestion evaluated by the subject 0-4 on the Nasal Congestion scale with 4 being the worst, not allowing half unit increments) at Visit 3.

    Time frame: 20(±1) minutes post-CAC on Day 1 (Visit 3)

  31. Secondary Efficacy Measures 7(±1) minutes post-CAC at Visit 4b; Conjunctival Redness

    Conjunctival redness evaluated by the investigator (0-4 on the Ocular Redness scale with 4 being the worst, allowing half unit increments) at Visit 4b.

    Time frame: 7(±1) minutes post-CAC at Visit 4b (24 hours from Visit 4a; Day 15±3)

  32. Secondary Efficacy Measures 15(±1) minutes post-CAC at Visit 4b; Conjunctival Redness

    Conjunctival redness evaluated by the investigator (0-4 on the Ocular Redness scale with 4 being the worst, allowing half unit increments) at Visit 4b.

    Time frame: 15(±1) minutes post-CAC at Visit 4b (24 hours from Visit 4a; Day 15±3)

  33. Secondary Efficacy Measures 20(±1) minutes post-CAC at Visit 4b; Conjunctival Redness

    Conjunctival redness evaluated by the investigator (0-4 on the Ocular Redness scale with 4 being the worst, allowing half unit increments) at Visit 4b.

    Time frame: 20(±1) minutes post-CAC at Visit 4b (24 hours from Visit 4a; Day 15±3)

  34. Secondary Efficacy Measures 7(±1) minutes post-CAC at Visit 4b; Ciliary Redness

    Ciliary redness evaluated by the investigator (0-4 on the Ocular Redness scale with 4 being the worst, allowing half unit increments) at Visit 4b.

    Time frame: 7(±1) minutes post-CAC at Visit 4b (24 hours from Visit 4a; Day 15±3)

  35. Secondary Efficacy Measures 15(±1) minutes post-CAC at Visit 4b; Ciliary Redness

    Ciliary redness evaluated by the investigator (0-4 on the Ocular Redness scale with 4 being the worst, allowing half unit increments) at Visit 4b.

    Time frame: 15(±1) minutes post-CAC at Visit 4b (24 hours from Visit 4a; Day 15±3)

  36. Secondary Efficacy Measures 20(±1) minutes post-CAC at Visit 4b; Ciliary Redness

    Ciliary redness evaluated by the investigator (0-4 on the Ocular Redness scale with 4 being the worst, allowing half unit increments) at Visit 4b.

    Time frame: 20(±1) minutes post-CAC at Visit 4b (24 hours from Visit 4a; Day 15±3)

  37. Secondary Efficacy Measures 7(±1) minutes post-CAC at Visit 4b; Episcleral Redness

    Episcleral redness evaluated by the investigator (0-4 on the Ocular Redness scale with 4 being the worst, allowing half unit increments) at Visit 4b.

    Time frame: 7(±1) minutes post-CAC at Visit 4b (24 hours from Visit 4a; Day 15±3)

  38. Secondary Efficacy Measures 15(±1) minutes post-CAC at Visit 4b; Episcleral Redness

    Episcleral redness evaluated by the investigator (0-4 on the Ocular Redness scale with 4 being the worst, allowing half unit increments) at Visit 4b.

    Time frame: 15(±1) minutes post-CAC at Visit 4b (24 hours from Visit 4a; Day 15±3)

  39. Secondary Efficacy Measures 20(±1) minutes post-CAC at Visit 4b; Episcleral Redness

    Episcleral redness evaluated by the investigator (0-4 on the Ocular Redness scale with 4 being the worst, allowing half unit increments) at Visit 4b.

    Time frame: 20(±1) minutes post-CAC at Visit 4b (24 hours from Visit 4a; Day 15±3)

  40. Secondary Efficacy Measures 7(±1) minutes post-CAC at Visit 4b; Chemosis

    Chemosis evaluated by the investigator (0-4 on the Ocular Chemosis scale with 4 being the worst, allowing half unit increments) at Visit 4b.

    Time frame: 7(±1) minutes post-CAC at Visit 4b (24 hours from Visit 4a; Day 15±3)

  41. Secondary Efficacy Measures 15(±1) minutes post-CAC at Visit 4b; Chemosis

    Chemosis evaluated by the investigator (0-4 on the Ocular Chemosis scale with 4 being the worst, allowing half unit increments) at Visit 4b.

    Time frame: 15(±1) minutes post-CAC at Visit 4b (24 hours from Visit 4a; Day 15±3)

  42. Secondary Efficacy Measures 20(±1) minutes post-CAC at Visit 4b; Chemosis

    Chemosis evaluated by the investigator (0-4 on the Ocular Chemosis scale with 4 being the worst, allowing half unit increments) at Visit 4b.

    Time frame: 20(±1) minutes post-CAC at Visit 4b (24 hours from Visit 4a; Day 15±3)

  43. Secondary Efficacy Measures 7(±1) minutes post-CAC at Visit 4b; Eyelid Swelling

    Eyelid swelling evaluated by the subject (0-3 on the Eyelid Swelling scale with 3 being the worst, not allowing half unit increments) at Visit 4b.

    Time frame: 7(±1) minutes post-CAC at Visit 4b (24 hours from Visit 4a; Day 15±3)

  44. Secondary Efficacy Measures 15(±1) minutes post-CAC at Visit 4b; Eyelid Swelling

    Eyelid swelling evaluated by the subject (0-3 on the Eyelid Swelling scale with 3 being the worst, not allowing half unit increments) at Visit 4b.

    Time frame: 15(±1) minutes post-CAC at Visit 4b (24 hours from Visit 4a; Day 15±3)

  45. Secondary Efficacy Measures 20(±1) minutes post-CAC at Visit 4b; Eyelid Swelling

    Eyelid swelling evaluated by the subject (0-3 on the Eyelid Swelling scale with 3 being the worst, not allowing half unit increments) at Visit 4b.

    Time frame: 20(±1) minutes post-CAC at Visit 4b (24 hours from Visit 4a; Day 15±3)

  46. Secondary Efficacy Measures 7(±1) minutes post-CAC at Visit 4b; Tearing

    Tearing evaluated by the subject (0-4 on the Tearing scale with 4 being the worst, not allowing half unit increments) at Visit 4b.

    Time frame: 7(±1) minutes post-CAC at Visit 4b (24 hours from Visit 4a; Day 15±3)

  47. Secondary Efficacy Measures 15(±1) minutes post-CAC at Visit 4b; Tearing

    Tearing evaluated by the subject (0-4 on the Tearing scale with 4 being the worst, not allowing half unit increments) at Visit 4b.

    Time frame: 15(±1) minutes post-CAC at Visit 4b (24 hours from Visit 4a; Day 15±3)

  48. Secondary Efficacy Measures 20(±1) minutes post-CAC at Visit 4b; Tearing

    Tearing evaluated by the subject (0-4 on the Tearing scale with 4 being the worst, not allowing half unit increments) at Visit 4b.

    Time frame: 20(±1) minutes post-CAC at Visit 4b (24 hours from Visit 4a; Day 15±3)

  49. Secondary Efficacy Measures 7(±1) minutes post-CAC at Visit 4b; Rhinorrhea

    Rhinorrhea evaluated by the subject (0-4 on the Rhinorrhea scale with 4 being the worst, not allowing half unit increments) at Visit 4b.

    Time frame: 7(±1) minutes post-CAC at Visit 4b (24 hours from Visit 4a; Day 15±3)

  50. Secondary Efficacy Measures 15(±1) minutes post-CAC at Visit 4b; Rhinorrhea

    Rhinorrhea evaluated by the subject (0-4 on the Rhinorrhea scale with 4 being the worst, not allowing half unit increments) at Visit 4b.

    Time frame: 15(±1) minutes post-CAC at Visit 4b (24 hours from Visit 4a; Day 15±3)

  51. Secondary Efficacy Measures 20(±1) minutes post-CAC at Visit 4b; Rhinorrhea

    Rhinorrhea evaluated by the subject (0-4 on the Rhinorrhea scale with 4 being the worst, not allowing half unit increments) at Visit 4b.

    Time frame: 20(±1) minutes post-CAC at Visit 4b (24 hours from Visit 4a; Day 15±3)

  52. Secondary Efficacy Measures 7(±1) minutes post-CAC at Visit 4b; Nasal Pruriti

    Nasal pruritis evaluated by the subject (0-4 on the Nasal Pruritis scale with 4 being the worst, not allowing half unit increments) at Visit 4b.

    Time frame: 7(±1) minutes post-CAC at Visit 4b (24 hours from Visit 4a; Day 15±3)

  53. Secondary Efficacy Measures 15(±1) minutes post-CAC at Visit 4b; Nasal Pruritis

    Nasal pruritis evaluated by the subject (0-4 on the Nasal Pruritis scale with 4 being the worst, not allowing half unit increments) at Visit 4b.

    Time frame: 15(±1) minutes post-CAC at Visit 4b (24 hours from Visit 4a; Day 15±3)

  54. Secondary Efficacy Measures 20(±1) minutes post-CAC at Visit 4b; Nasal Pruritis

    Nasal pruritis evaluated by the subject (0-4 on the Nasal Pruritis scale with 4 being the worst, not allowing half unit increments) at Visit 4b.

    Time frame: 20(±1) minutes post-CAC at Visit 4b (24 hours from Visit 4a; Day 15±3)

  55. Secondary Efficacy Measures 7(±1) minutes post-CAC at Visit 4b; Ear or Palate Pruritis

    Ear or palate pruritis evaluated by the subject (0-4 on the Ear or Palate Pruritis scale with 4 being the worst, not allowing half unit increments) at Visit 4b.

    Time frame: 7(±1) minutes post-CAC at Visit 4b (24 hours from Visit 4a; Day 15±3)

  56. Secondary Efficacy Measures 15(±1) minutes post-CAC at Visit 4b; Ear or Palate Pruritis

    Ear or palate pruritis evaluated by the subject (0-4 on the Ear or Palate Pruritis scale with 4 being the worst, not allowing half unit increments) at Visit 4b.

    Time frame: 15(±1) minutes post-CAC at Visit 4b (24 hours from Visit 4a; Day 15±3)

  57. Secondary Efficacy Measures 20(±1) minutes post-CAC at Visit 4b; Ear or Palate Pruritis

    Ear or palate pruritis evaluated by the subject (0-4 on the Ear or Palate Pruritis scale with 4 being the worst, not allowing half unit increments) at Visit 4b.

    Time frame: 20(±1) minutes post-CAC at Visit 4b (24 hours from Visit 4a; Day 15±3)

  58. Secondary Efficacy Measures 7(±1) minutes post-CAC at Visit 4b; Nasal Congestion

    Nasal congestion pruritis evaluated by the subject (0-4 on the Nasal Congestion scale with 4 being the worst, not allowing half unit increments) at Visit 4b.

    Time frame: 7(±1) minutes post-CAC at Visit 4b (24 hours from Visit 4a; Day 15±3

  59. Secondary Efficacy Measures 15(±1) minutes post-CAC at Visit 4b; Nasal Congestion

    Nasal congestion pruritis evaluated by the subject (0-4 on the Nasal Congestion scale with 4 being the worst, not allowing half unit increments) at Visit 4b.

    Time frame: 15(±1) minutes post-CAC at Visit 4b (24 hours from Visit 4a; Day 15±3)

  60. Secondary Efficacy Measures 20(±1) minutes post-CAC at Visit 4b; Nasal Congestion

    Nasal congestion pruritis evaluated by the subject (0-4 on the Nasal Congestion scale with 4 being the worst, not allowing half unit increments) at Visit 4b.

    Time frame: 20(±1) minutes post-CAC at Visit 4b (24 hours from Visit 4a; Day 15±3)

07

Study locations

1 site
  • Andover Eye Associates
    Andover, Massachusetts 01810, United States
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Dec 2021 to primary completion in Jul 2022, 6 months.

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

Registered
Dec 17, 2021
First posted
Apr 6, 2022
StartActual
Dec 31, 2021
Primary completionActual
Jul 24, 2022
CompletionActual
Jul 24, 2022
Last update
Sep 2, 2022
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 Sep 2, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05314621
Lead sponsor
Andover Research Eye Institute
Responsible party
Sponsor
First posted
Apr 6, 2022
Start date
Dec 31, 2021
Primary completion
Jul 24, 2022
Completion
Jul 24, 2022
Last update
Sep 2, 2022

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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Studies of the drugs tested here: Olopatadine · Fluticasone

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Andover Research Eye Institute

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