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

NCT ID: NCT06493604

Last Updated: 2025-12-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

116 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-06-24

Study Completion Date

2025-02-27

Brief Summary

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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

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Dry eye chamber challenge trial

Conditions

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Dry Eye Disease

Keywords

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reproxalap

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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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

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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

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Inclusion Criteria

* 18 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

Exclusion Criteria

* 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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Aldeyra Therapeutics, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Andover Eye Associates

Andover, Massachusetts, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

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ADX-102-DED-032

Identifier Type: -

Identifier Source: org_study_id