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

Phase 3

Recruiting

• Conditions: Dry Eye Disease
• Interventions: Drug: Reproxalap Ophthalmic Solution (0.25%); Drug: Vehicle Ophthalmic Solution

• Registration Number: NCT06493604
• Lead Sponsor: Aldeyra Therapeutics, Inc.

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

Study Timeline

• Study Start: 2024-06-24
• Status Verified: 2024-07
• Study First Submitted: 2024-07-02
• Study First Submitted QC: 2024-07-02
• Last Update Submitted: 2024-07-02
• Study First Posted: 2024-07-10
• Last Update Posted: 2024-07-10
• Primary Completion: 2024-12-31
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 110

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

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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)

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Reproxalap Ophthalmic Solution (0.25%) administered six times over two consecutive days	Reproxalap Ophthalmic Solution (0.25%)	-
Vehicle Ophthalmic Solution administered six times over two consecutive days	Vehicle Ophthalmic Solution	-

Primary Outcome Measures

Name	Time	Method
Ocular discomfort symptom score over 100 minutes in the dry eye chamber at Visit 1 and Visit 3	Day -14 to Day 2	Measured using a 0 - 100 visual analog scale (VAS) where 0 is "no discomfort" and 100 is "maximal discomfort"

Trial Locations

Locations (1)

Andover Eye Associates; 🇺🇸 Andover, Massachusetts, United States