The INVIGORATE 2 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

NCT05234554

ADX-102-AC-026

Details and patient eligibility

About

The INVIGORATE 2 Trial: A single-center, 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: 131 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Be at least 18 years of age at the time of screening of either sex or any race;
• Provide written informed consent;
• Be willing and able to follow instructions, and can attend all required clinical trial visits.
• Have at least a two-year history of moderate-to-severe ragweed-induced allergic conjunctivitis based on investigator's judgement;
• Have a positive skin prick test to ragweed pollen within the past year of the Medical Screening Visit (Visit 1).

Exclusion criteria

• Have a history of blepharitis, dry eye syndrome, herpes simplex keratitis, or herpes zoster keratitis;
• Have systemic signs of infection (e.g., fever, current treatment with antibiotics).
• Have a systemic disease or uncontrolled medical condition, which, in the opinion of the investigator, could interfere with clinical trial measurements or subject compliance. Such diseases or conditions would include, but are not limited to, cancer, alcoholism, drug dependency or abuse, or psychiatric disease;
• Be a WOCBP who is pregnant, nursing, or not using an effective means of contraception;
• Have any known contraindication or hypersensitivities to any components of the Investigational Product (IP) drug formulation.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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131 participants in 2 patient groups, including a placebo group

Reproxalap Ophthalmic Solution (0.25%)

Experimental group

Treatment:

Drug: Reproxalap Ophthalmic Solution (0.25%)

Vehicle Ophthalmic Solution

Placebo Comparator group

Treatment:

Drug: Vehicle Ophthalmic Solution