A Multi-Center, Randomized, Double Masked, Parallel-Group, Vehicle-Controlled, Clinical Study to Assess the Safety and Efficacy of Reproxalap Ophthalmic Solution in Subjects With Dry Eye Disease

Completed · Phase 2

Conditions studied: Dry Eye Syndrome

In brief

A Multi-Center, Phase 2b, Randomized, Double Masked, Parallel-Group, Vehicle-Controlled, Clinical Study to Assess the Safety and Efficacy of Reproxalap Ophthalmic Solution (0.25% and 0.1%) Compared to Vehicle in Subjects with Dry Eye Disease

Key facts

Study ID

NCT03404115

Run by

Aldeyra Therapeutics, Inc.

People needed

300

Starts

2018-01-02

Expected to finish

2018-07-11

Last updated by the study team

2025-02-06

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Be at least 18 years of age of either gender and any race;
• Have a reported history of dry eye for at least 6 months prior to Visit 1;
• Have a history of use or desire to use eye drops for dry eye symptoms within 6 months of Visit 1;

You may not qualify if…

• Have any 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;
• Be diagnosed with an ongoing ocular infection (bacterial, viral, or fungal), or active ocular inflammation at Visit 1;
• Have worn contact lenses within 7 days of Visit 1 or anticipate using contact lenses during the study;
• Have used any eye drops within 2 hours of Visit 1;
• Have previously had laser-assisted in situ keratomileusis (LASIK) surgery within the last 12 months;
• Have used cyclosporine 0.05% or lifitigrast 5.0% ophthalmic solution within 90 days of Visit 1;
• Have any planned ocular and/or lid surgeries over the study period or any ocular surgery within 6 months of Visit 1;
• Be using or anticipate using temporary punctal plugs during the study that have not been stable within 30 days of Visit 1;

Where it is running

• The Eye Care Group — Waterbury, Connecticut, United States
• Midwest Cornea Associates — Indianapolis, Indiana, United States
• Central Maine Eye Care — Lewiston, Maine, United States
• Andover Eye Associates — Andover, Massachusetts, United States
• Andover Eye Associates — Raynham, Massachusetts, United States
• Total Eye Care — Memphis, Tennessee, United States

Full record on ClinicalTrials.gov

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