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

Phase 2

Completed

• Conditions: Dry Eye Syndrome
• Interventions: Drug: Reproxalap Ophthalmic Solution (0.25%); Drug: Vehicle Ophthalmic Solution; Drug: Reproxalap Ophthalmic Solution (0.1%)

• Registration Number: NCT03404115
• Lead Sponsor: Aldeyra Therapeutics, Inc.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2018-01-02
• Study First Submitted: 2018-01-12
• Study First Submitted QC: 2018-01-12
• Study First Posted: 2018-01-19
• Primary Completion: 2018-07-11
• Study Completion: 2018-07-11
• Disposition First Submitted: 2019-07-10
• Status Verified: 2023-01
• Results First Submitted: 2023-01-30
• Results First Submitted QC: 2025-01-14
• Last Update Submitted: 2025-01-14
• Results First Posted: 2025-02-06
• Disposition First Posted: 2025-02-06
• Last Update Posted: 2025-02-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

• 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;

Exclusion Criteria

• 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;

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Reproxalap Ophthalmic Solution (0.25%)	Reproxalap Ophthalmic Solution (0.25%)	-
Vehicle Ophthalmic Solution	Vehicle Ophthalmic Solution	-
Reproxalap Ophthalmic Solution (0.1%)	Reproxalap Ophthalmic Solution (0.1%)	-

Primary Outcome Measures

Name	Time	Method
Efficacy of ADX-102 on the Ora Calibra® Discomfort & 4-Symptom Questionnaire for Dryness.	Efficacy assessment period (Day 1 through Day 85) - assessed on Days 1, 15, 29, 57, and 85.	Change from baseline comparison of ADX-102 to Vehicle on the Ora Calibra® Discomfort \& 4-Symptom Questionnaire (0 = least, 5 = most) for dryness across all time points. The intervention was administered bilaterally. The Least Squares Mean (Standard Error) was derived from Mixed Model Repeated Measure for change from baseline calculated using baseline score, visit, treatment, and visit-by-treatment interaction.

Trial Locations

Locations (5)

Midwest Cornea Associates; 🇺🇸 Indianapolis, Indiana, United States

Total Eye Care; 🇺🇸 Memphis, Tennessee, United States

Central Maine Eye Care; 🇺🇸 Lewiston, Maine, United States

The Eye Care Group; 🇺🇸 Waterbury, Connecticut, United States

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