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

NCT06389214 | Completed Phase 3 FDA Drug

• 1 other identifier: ADX-102-DED-030
• Study Type: interventional
• Target: 132
• Locations: 1 country
• Sites: 1

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

Conditions

Dry Eye Disease

Keywords

dry eye; reproxalap

Outcome Measures

Primary Outcomes (1)

• Ocular discomfort symptom score over 100 minutes in the dry eye chamber at Visit 2 and Visit 4

  Measured using a 0 - 100 visual analog scale (VAS) where 0 is "no discomfort" and 100 is "maximal discomfort"

  From Day -14 to Day 2

Study Arms (2)

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

EXPERIMENTAL

Drug: Reproxalap Ophthalmic Solution (0.25%)

Vehicle Ophthalmic Solution administered six times over two consecutive days

PLACEBO COMPARATOR

Drug: Vehicle Ophthalmic Solution

Interventions

Reproxalap Ophthalmic Solution (0.25%) DRUG

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

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

Vehicle Ophthalmic Solution DRUG

Vehicle Ophthalmic Solution administered six times over two consecutive days

Vehicle Ophthalmic Solution administered six times over two consecutive days

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Aldeyra Therapeutics, Inc.: lead

Study Sites (1)

Cliantha Research

Mississauga, Ontario, Canada

Location

MeSH Terms

Conditions

Dry Eye Syndromes

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases

Study Officials

• Patricia Couroux, MD

  Cliantha Research

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 25, 2024
• First Posted: April 29, 2024
• Study Start: April 9, 2024
• Primary Completion: June 11, 2024
• Study Completion: June 11, 2024
• Last Updated: June 5, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)