The INVIGORATE Trial: A Clinical Trial to Assess the Efficacy and Safety of Subjects With Seasonal Allergic Conjunctivitis.
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|ClinicalTrials.gov Identifier: NCT04207736|
Recruitment Status : Recruiting
First Posted : December 23, 2019
Last Update Posted : February 2, 2021
|Condition or disease||Intervention/treatment||Phase|
|Allergic Conjunctivitis||Drug: Reproxalap Ophthalmic Solution (0.25%) Drug: Vehicle Ophthalmic Solution||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||126 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||The INVIGORATE Trial: A Randomized, Double-masked, Crossover Design, Vehicle-controlled Phase 3 Clinical Trial to Assess the Efficacy and Safety of Reproxalap Ophthalmic Solution (0.25%) Compared to Vehicle in Subjects With Seasonal Allergic Conjunctivitis Using the Environmental Exposure Chamber (EEC)|
|Actual Study Start Date :||December 5, 2019|
|Estimated Primary Completion Date :||June 2021|
|Estimated Study Completion Date :||June 2021|
|Active Comparator: Reproxalap Ophthalmic Solution (0.25%)||
Drug: Reproxalap Ophthalmic Solution (0.25%)
Reproxalap Ophthalmic Solution (0.25%) dosed in the Environmental Exposure Chamber.
|Placebo Comparator: Vehicle Ophthalmic Solution||
Drug: Vehicle Ophthalmic Solution
Vehicle Ophthalmic Solution dosed in the Environmental Exposure Chamber.
- Ocular itching evaluated by the Subject. [ Time Frame: During EEC allergen exposure. ]The method of assessment for the primary outcome is a 9-point ocular itch scale (0 none - 4 severe).
- Conjunctival Redness evaluated by the Subject. [ Time Frame: During EEC allergen exposure. ]The method of assessment for the key secondary outcome is a 9-point ocular redness scale (0 none -4 extremely sever).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04207736
|Contact: Bill Cavanaghemail@example.com|
|Mississauga, Ontario, Canada|
|Contact: Peter Couroux, MD 905-282-1808 firstname.lastname@example.org|