CompletedPhase 4

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

United States61 participantsStarted 2021-12-31

Plain-language summary

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

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Be at least 18 years of age at Visit 1 of either gender and any race;
✓. Provide written informed consent and sign the HIPAA form;
✓. Be willing and able to follow all instructions and attend all study visits;
✓. Be able to self-administer eyedrops and nasal spray satisfactorily or have a caregiver at home routinely available for this purpose;
✓. 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;

Exclusion criteria

✕. Be able and willing to discontinue wearing contact lenses for at least 72 hours prior to Visit 1 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 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);
✕. Have a calculated best-corrected visual acuity of 0.7 logMAR or better in each eye as measured using an ETDRS chart;
✕0. 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;
✕1. 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.
✕. Have known contraindications or sensitivities to the use of the investigational 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, clinically significant blepharitis, follicular conjunctivitis, iritis, pterygium, history of corneal transplantation or a diagnosis of dry eye);
✕. 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;

What they're measuring

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

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

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

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

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

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

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

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

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

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

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

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

Trial details

NCT IDNCT05314621

SponsorAndover Research Eye Institute

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2022-07-24

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