A Study Comparing the Efficacy of Pataday® Once Daily Relief Extra Strength to Claritin® Tablets … (NCT05265910) | Clinical Trial Compass
CompletedPhase 4
A Study Comparing the Efficacy of Pataday® Once Daily Relief Extra Strength to Claritin® Tablets 24-Hour in Subjects With Allergic Conjunctivitis
United States58 participantsStarted 2021-12-14
Plain-language summary
This is a single-center, randomized, double-masked, parallel study. In this clinical study, the efficacy comparison between Pataday® Once Daily Relief Extra Strength and Claritin® Tablets 24-Hour will be made using the Ora-CAC model, a validated clinical model accepted by regulatory agents for assessing the efficacy of products on the signs and symptoms of allergic conjunctivitis.
Who can participate
Age range18 Years
SexALL
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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;
✓. 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;
✕. 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;
What they're measuring
1
Ocular itching 3(±1) minutes post-CAC at Visit 3
Timeframe: 3(±1) minutes post-CAC on Day 1 (Visit 3)
2
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)
3
Ocular itching 5(±1) minutes post-CAC at Visit 3
Timeframe: 5(±1) minutes post-CAC on Day 1 (Visit 3)
4
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)
5
Ocular itching 7(±1) minutes post-CAC at Visit 3
Timeframe: 7(±1) minutes post-CAC on Day 1 (Visit 3)
6
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)
0. 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.