A Clinical Trial to Assess the Efficacy and Safety of Subjects With Dry Eye Disease

NCT ID: NCT06389214

Last Updated: 2025-06-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 132 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-04-09
• Study Completion Date: 2024-06-11

Brief Summary

A Randomized, Double-Masked, Vehicle-Controlled Parallel Group Clinical Trial to Assess Efficacy and Safety of 0.25% Reproxalap Ophthalmic Solution Compared to Vehicle in Subjects with Dry Eye Disease

Detailed Description

Dry eye chamber challenge trial.

Conditions

Dry Eye Disease

Study Design

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

Study Groups

Reproxalap Ophthalmic Solution (0.25%) administered six times over two consecutive days

Group Type: EXPERIMENTAL

Reproxalap Ophthalmic Solution (0.25%)

Intervention Type: DRUG

Reproxalap Ophthalmic Solution (0.25%) administered six times over two consecutive days

Vehicle Ophthalmic Solution administered six times over two consecutive days

Group Type: PLACEBO_COMPARATOR

Vehicle Ophthalmic Solution

Intervention Type: DRUG

Vehicle Ophthalmic Solution administered six times over two consecutive days

Interventions

Reproxalap Ophthalmic Solution (0.25%)

Reproxalap Ophthalmic Solution (0.25%) administered six times over two consecutive days

Intervention Type: DRUG

Vehicle Ophthalmic Solution

Vehicle Ophthalmic Solution administered six times over two consecutive days

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Eighteen to 70 years of age at the time of screening (either gender and any race)
• Ability to provide written informed consent
• Reported history of ocular discomfort associated with dry eye disease for at least 6 months prior to Visit 1
• Reported history of the use of eye drops for dry eye disease between 2 weeks to 6 months prior to Visit 1

Exclusion Criteria

• Clinically significant slit lamp findings, intraocular pressure, and visual acuity findings at Visit 2 that may include active blepharitis, severe meibomian gland dysfunction, lid margin inflammation, glaucoma, ocular allergy, infection or any other disorder that, in the opinion of the Investigator, may interfere with trial conduct or assessments
• Diagnosis at Visit 1 of an ongoing ocular infection (bacterial, viral, or fungal), active ocular inflammation, or history of inflammatory disease that, in the opinion of the Investigator, could interfere with trial conduct or assessments
• Contact lens use within 7 days of Visit 1 or anticipated use of contact lenses during the trial
• Laser-assisted in situ keratomileusis (LASIK) surgery within 12 months of Visit 1 and/or planned ocular and/or lid surgeries during the trial or any other ocular surgery within 6 months of Visit 1
• Systemic corticosteroid or other immunomodulatory therapy (not including inhaled corticosteroids) within 60 days of Visit 1, or any planned immunomodulatory therapy during the trial
• Eye drop use within 2 weeks of Visit 1 and/or an unwillingness to discontinue any topical ophthalmic prescription or over-the-counter solutions, artificial tears, gels, or scrubs for the duration of the trial (excluding medications allowed for the conduct of the trial)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Aldeyra Therapeutics, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Patricia Couroux, MD

Role: PRINCIPAL_INVESTIGATOR

Cliantha Research

Locations

Cliantha Research

Mississauga, Ontario, Canada

Countries

Canada

Other Identifiers

ADX-102-DED-030

Identifier Type: -

Identifier Source: org_study_id