A Study Comparing the Efficacy of Pataday® Once Daily Relief Extra Strength to Flonase® Allergy R… (NCT05314621) | Clinical Trial Compass
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 range
18 Years
Sex
ALL
See this in plain English?
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);
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
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)
. 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;