A Multi-Center, Double-Masked, Randomized, Vehicle-Controlled, Parallel-Group Clinical Trial Evaluating the Safety of Reproxalap Ophthalmic Solution in Subjects With Dry Eye Disease

Phase 3

Completed

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

• Registration Number: NCT04735393
• Lead Sponsor: Aldeyra Therapeutics, Inc.

Brief Summary

A Multi-Center, Double-Masked, Randomized, Vehicle-Controlled, Parallel-Group Clinical Trial Evaluating the Safety of 0.25% Reproxalap Ophthalmic Solution in Subjects with Dry Eye Disease

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-01-25
• Study Start: 2021-01-26
• Study First Submitted QC: 2021-02-01
• Study First Posted: 2021-02-03
• Primary Completion: 2022-10-11
• Study Completion: 2022-10-11
• Disposition First Submitted: 2023-05-31
• Disposition First Posted: 2023-06-02
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-14
• Last Update Posted: 2025-01-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 757

Inclusion Criteria

• 18 years of age (either gender and any race);
• Reported history of dry eye for at least 6 months prior to Visit 1;
• 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 (MGD), 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 anticipate using contact lenses during the trial;
• Eye drop use within 2 hours of Visit 1;
• Previous laser-assisted in situ keratomileusis (LASIK) surgery within the last 12 months;
• Cyclosporine 0.05% or 0.09% or lifitegrast 5.0% ophthalmic solution within 90 days of Visit 1;
• Planned ocular and/or lid surgeries over the study period or any ocular surgery within 6 months of Visit 1;
• Temporary punctal plugs during the study that have not been stable within 30 days of Visit 1.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Reproxalap (0.25%) for six weeks	Reproxalap Ophthalmic Solution (0.25%)	Reproxalap four times daily (QID) for four weeks followed by two times daily (BID) for two weeks
Vehicle for six weeks	Placebo Comparator	Vehicle QID for four weeks followed by BID for two weeks
Reproxalap (0.25%) for 12 months	Reproxalap Ophthalmic Solution (0.25%)	Reproxalap (0.25%) QID for four weeks followed by BID for 11 months
Vehicle for 12 months	Placebo Comparator	Vehicle QID for four weeks followed by BID for 11 months

Primary Outcome Measures

Name	Time	Method
Ocular treatment emergent adverse events (TEAEs)	Safety assessment period (Day 1 through Day 28 or Day 1 through Day 360)	Percentages of subjects with ocular treatment-emergent adverse events (TEAEs).

Trial Locations

Locations (1)

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