The INVIGORATE Trial: A Clinical Trial to Assess the Efficacy and Safety of Subjects With Seasonal Allergic Conjunctivitis.

Aldeyra Therapeutics

Status and phase: Completed; Phase 3

Conditions: Allergic Conjunctivitis

Treatments: Drug: Reproxalap Ophthalmic Solution (0.25%); Drug: Vehicle Ophthalmic Solution

Study type: Interventional

Funder types: Industry

Identifiers

NCT04207736

ADX-102-AC-017

Details and patient eligibility

About

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.

Full description

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).

Enrollment: 95 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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95 participants in 2 patient groups, including a placebo group

Reproxalap Ophthalmic Solution (0.25%)

Active Comparator group

Treatment:

Drug: Reproxalap Ophthalmic Solution (0.25%)

Vehicle Ophthalmic Solution

Placebo Comparator group

Treatment:

Drug: Vehicle Ophthalmic Solution