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 : Completed
First Posted : December 23, 2019
Last Update Posted : January 5, 2022
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|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)|
|Actual Enrollment :||95 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|
|Actual Primary Completion Date :||February 16, 2021|
|Actual Study Completion Date :||February 16, 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).
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|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- be at least 18 years of age of either gender and any race
- have at least a two-year history of moderate-to-severe ragweed-induced allergic conjunctivitis based on principal investigator's judgement
- have a positive skin prick test to ragweed pollen within the past year of screening
- known contraindication or hypersensitivities to any components of the investigational product medication or components
- history of uveitis, blepharitis, dry eye syndrome, herpes simplex keratitis, or herpes zoster keratitis;
- presence of any ocular infection (bacterial, viral, or fungal) or active ocular inflammation (e.g., follicular conjunctivitis, allergic conjunctivitis) within 14 days prior to screening
- presence of any chronic ocular degenerative condition or ocular inflammation that, in the opinion of the investigator, is likely to worsen over the course of the clinical trial;
- diagnosis of moderate-to-severe pinguecula or pterygium (particularly if it results in chronic erythema), Stevens-Johnson Syndrome, ocular cicatricial pemphigoid, mucous membrane pemphigoid, significant conjunctival scarring, chemical burn, herpetic or neurotrophic keratitis, Cryopyrin Associated Periodic Syndrome (CAPS), or keratoconus
- woman of childbearing potential who is pregnant or nursing
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
|Mississauga, Ontario, Canada|
|Responsible Party:||Aldeyra Therapeutics, Inc.|
|Other Study ID Numbers:||
|First Posted:||December 23, 2019 Key Record Dates|
|Last Update Posted:||January 5, 2022|
|Last Verified:||January 2022|
|Studies a U.S. FDA-regulated Drug Product:||Yes|
|Studies a U.S. FDA-regulated Device Product:||No|
Immune System Diseases