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

NCT06493604 | Completed Phase 3 FDA Drug

• 1 other identifier: ADX-102-DED-032
• Study Type: interventional
• Target: 116
• 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

reproxalap

Outcome Measures

Primary Outcomes (1)

• Ocular discomfort symptom score over 100 minutes in the dry eye chamber at Visit 1 and Visit 3

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

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

You may qualify if:

• years of age (either gender and any race)
• Ability to provide written informed consent and sign the Health Information Portability and Accountability Act form
• Reported history of ocular discomfort associated with dry eye disease for at least 6 months prior to Visit 1
• Reported history of use or desire to use eye drops for dry eye symptoms within 6 months of Visit 1

You may not qualify if:

• Clinically significant slit lamp findings at Visit 1 that may include active blepharitis, meibomian gland dysfunction, lid margin inflammation, or active ocular allergies that require therapeutic treatment, and/or in the opinion of the investigator may interfere with study parameters
• Diagnosis of an ongoing ocular infection (bacterial, viral, or fungal), or active ocular inflammation at Visit 1
• Contact lens use within 7 days of Visit 1 or anticipated use of contact lenses during the trial
• Previous laser-assisted in situ keratomileusis surgery within the last 12 months
• Systemic corticosteroid or other immunomodulator therapy (not including inhaled corticosteroids) within 14 days of Visit 1, or any planned immunomodulatory therapy throughout the clinical trial
• Use of and unwillingness to discontinue topical ophthalmic prescriptions (including medications for glaucoma) or over-the-counter solutions (not including 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)

Andover Eye Associates

Andover, Massachusetts, 01810, United States

Location

MeSH Terms

Conditions

Dry Eye Syndromes

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases

Study Design

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

Study Record Dates

• First Submitted: July 2, 2024
• First Posted: July 10, 2024
• Study Start: June 24, 2024
• Primary Completion: February 27, 2025
• Study Completion: February 27, 2025
• Last Updated: December 22, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)