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

Dry Eye Disease Clinical Trial

Official title:

A Multicenter, Phase 3, Randomized, Double-Masked, Parallel-Group, Vehicle-Controlled, Environment Exposure Clinical Trial to Assess the Efficacy and Safety of 0.25% Reproxalap Ophthalmic Solution Compared to Vehicle in Subjects With Dry Eye Disease

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06424444
• Other study ID #: ADX-102-DED-031
• Status: Recruiting
• Phase: Phase 3
• Start date: April 29, 2024
• Est. completion date: December 31, 2024

Study information

• Verified date: May 2024
• Source: Aldeyra Therapeutics, Inc.
• Contact: Bill Cavanagh
• Phone: 781-257-3063
• Email: bcavanagh[@]aldeyra.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

A Multicenter, Phase 3, Randomized, Double-Masked, Parallel-Group, Vehicle-Controlled, Environment Exposure Clinical Trial to Assess the Efficacy and Safety of 0.25% Reproxalap

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 400
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• at least 18 years of age;

• written informed consent and sign the Health Information Portability and Accountability Act (HIPAA) form;

• history of use or desire to use eye drops for dry eye symptoms within 6 months of Visit 1

Exclusion Criteria:

• ongoing ocular infection (bacterial, viral, or fungal) or active ocular inflammation at Visit 1;

• contact lenses within 7 days of Visit 1 or anticipate using contact lenses during the trial;

• eye drops within 2 hours of Visit 1;

• laser-assisted in situ keratomileusis (LASIK) surgery within the last 12 months;

• topical ocular cyclosporine, lifitegrast, corticosteroid, or any other topical ocular prescription medication within 90 days of Visit 1

Related Conditions & MeSH terms

• Dry Eye Disease
• Dry Eye Syndromes
• Eye Diseases
• Keratoconjunctivitis Sicca

Intervention

Drug:
• Reproxalap ophthalmic solution (0.25%)
Reproxalap ophthalmic solution (0.25%) administered QID for four weeks, followed by BID administration for two weeks
• Vehicle ophthalmic solution
Vehicle ophthalmic solution administered QID for four weeks, followed by BID administration for two weeks

Locations

Country	Name	City	State
United States	Core, Inc.	Shelby	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Aldeyra Therapeutics, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Subject-reported ocular discomfort score over Week 1 to Week 6	Measured using a 0 - 100 visual analog scale where 0 is "no discomfort" and 100 is "maximal discomfort"	From Day -14 to Day 43