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
• Status Verified: 2022-02
• Primary Completion: 2022-10-11
• Study Completion: 2022-10-11
• Disposition First Submitted: 2023-05-31
• Last Update Submitted: 2023-05-31
• Disposition First Posted: 2023-06-02
• Last Update Posted: 2023-06-02

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.

Read More

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.

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Reproxalap Ophthalmic Solution (0.25%) QID for four weeks followed by BID for two weeks.	Reproxalap Ophthalmic Solution (0.25%)	-
Vehicle Ophthalmic Solution QID for four weeks followed by BID for two weeks.	Placebo Comparator	-
Reproxalap Ophthalmic Solution (0.25%) QID for four weeks followed by BID for 11 months.	Reproxalap Ophthalmic Solution (0.25%)	-
Vehicle Ophthalmic Solution QID for four weeks followed by BID for 11 months.	Placebo Comparator	-

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