The INVIGORATE 2 Trial: A Clinical Trial to Assess the Efficacy and Safety of Subjects With Seasonal Allergic Conjunctivitis

NCT ID: NCT05234554

Last Updated: 2024-04-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 131 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-01-21
• Study Completion Date: 2023-04-22

Brief Summary

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).

Conditions

Allergic Conjunctivitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Reproxalap Ophthalmic Solution (0.25%)

Group Type: EXPERIMENTAL

Reproxalap Ophthalmic Solution (0.25%)

Intervention Type: DRUG

Reproxalap Ophthalmic Solution (0.25%) dosed twice.

Vehicle Ophthalmic Solution

Group Type: PLACEBO_COMPARATOR

Vehicle Ophthalmic Solution

Intervention Type: DRUG

Vehicle Ophthalmic Solution dosed twice.

Interventions

Reproxalap Ophthalmic Solution (0.25%)

Reproxalap Ophthalmic Solution (0.25%) dosed twice.

Intervention Type: DRUG

Vehicle Ophthalmic Solution

Vehicle Ophthalmic Solution dosed twice.

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Aldeyra Therapeutics, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Cliantha Research

Mississauga, Ontario, Canada

Countries

Canada

Other Identifiers

ADX-102-AC-026

Identifier Type: -

Identifier Source: org_study_id