Allergic Conjunctivitis Clinical Trial
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)
Verified date | January 2022 |
Source | Aldeyra Therapeutics, Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The INVIGORATE Trial: A Randomized, Double-masked, Crossover Design, Phase 3 Clinical Trial to Assess the Efficacy and Safety of Subjects With Seasonal Allergic Conjunctivitis.
Status | Completed |
Enrollment | 95 |
Est. completion date | February 16, 2021 |
Est. primary completion date | February 16, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - 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 Exclusion Criteria: - 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 |
Country | Name | City | State |
---|---|---|---|
Canada | Cliantha Research | Mississauga | Ontario |
Lead Sponsor | Collaborator |
---|---|
Aldeyra Therapeutics, Inc. |
Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Ocular itching evaluated by the Subject. | The method of assessment for the primary outcome is a 9-point ocular itch scale (0 none - 4 severe). | During EEC allergen exposure. | |
Secondary | Conjunctival Redness evaluated by the Subject. | The method of assessment for the key secondary outcome is a 9-point ocular redness scale (0 none -4 extremely sever). | During EEC allergen exposure. |
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