A Phase 3 Clinical Trial to Assess the Efficacy and Safety of Subjects With Dry Eye Disease

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

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

Study Overview

• Status: Recruiting
• Conditions: Dry Eye Disease
• Intervention / Treatment: Drug: Reproxalap Ophthalmic Solution (0.25%); Drug: Vehicle Ophthalmic Solution

Detailed Description

Dry eye chamber challenge trial.

• Study Type: Interventional
• Enrollment (Estimated): 110
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Bill Cavanagh; Phone Number: (781) 761-4904; Email: bcavanagh@aldeyra.com

Study Locations

• Canada
  • Ontario
    • Mississauga, Ontario, Canada
      • Recruiting
      • Cliantha Research
      • Contact: Patricia Couroux, MD; Phone Number: (888) 989-1808; Email: pcouroux@cliantha.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Reproxalap Ophthalmic Solution (0.25%) administered six times over two consecutive days	Drug: Reproxalap Ophthalmic Solution (0.25%); Reproxalap Ophthalmic Solution (0.25%) administered six times over two consecutive days
Placebo Comparator: Vehicle Ophthalmic Solution administered six times over two consecutive days	Drug: Vehicle Ophthalmic Solution; Vehicle Ophthalmic Solution administered six times over two consecutive days

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Aldeyra Therapeutics, Inc.
• Investigators: Principal Investigator: Patricia Couroux, MD, Cliantha Research

Study record dates

Study Major Dates

• Study Start (Actual): April 9, 2024
• Primary Completion (Estimated): December 31, 2024
• Study Completion (Estimated): December 31, 2024

Study Registration Dates

• First Submitted: April 25, 2024
• First Submitted That Met QC Criteria: April 25, 2024
• First Posted (Actual): April 29, 2024

Study Record Updates

• Last Update Posted (Actual): April 29, 2024
• Last Update Submitted That Met QC Criteria: April 25, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: dry eye; reproxalap
• Additional Relevant MeSH Terms: Lacrimal Apparatus Diseases; Keratoconjunctivitis; Conjunctivitis; Conjunctival Diseases; Keratitis; Corneal Diseases; Eye Diseases; Dry Eye Syndromes; Keratoconjunctivitis Sicca; Ophthalmic Solutions; Pharmaceutical Solutions
• Other Study ID Numbers: ADX-102-DED-030

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No