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

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

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

Study Overview

• Status: Completed
• Conditions: Dry Eye Disease
• Intervention / Treatment: Drug: Reproxalap Ophthalmic Solution (0.25%); Drug: Reproxalap Ophthalmic Solution (0.25%); Drug: Placebo Comparator; Drug: Placebo Comparator

• Study Type: Interventional
• Enrollment (Actual): 757
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Andover, Massachusetts, United States, 01810
      • Andover Eye Associates

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Reproxalap (0.25%) for six weeks; Reproxalap four times daily (QID) for four weeks followed by two times daily (BID) for two weeks	Drug: Reproxalap Ophthalmic Solution (0.25%); Reproxalap Ophthalmic Solution (0.25%) administered for six weeks (QID for four weeks then BID for two weeks).; Drug: Reproxalap Ophthalmic Solution (0.25%); Reproxalap Ophthalmic Solution (0.25%) administered for one year (QID for four weeks then BID for 11 months).
Placebo Comparator: Vehicle for six weeks; Vehicle QID for four weeks followed by BID for two weeks	Drug: Placebo Comparator; Vehicle Ophthalmic Solution administered for six weeks (QID for four weeks then BID for two weeks).; Drug: Placebo Comparator; Vehicle Ophthalmic Solution administered for one year (QID for four weeks then BID for 11 months).
Experimental: Reproxalap (0.25%) for 12 months; Reproxalap (0.25%) QID for four weeks followed by BID for 11 months	Drug: Reproxalap Ophthalmic Solution (0.25%); Reproxalap Ophthalmic Solution (0.25%) administered for six weeks (QID for four weeks then BID for two weeks).; Drug: Reproxalap Ophthalmic Solution (0.25%); Reproxalap Ophthalmic Solution (0.25%) administered for one year (QID for four weeks then BID for 11 months).
Placebo Comparator: Vehicle for 12 months; Vehicle QID for four weeks followed by BID for 11 months	Drug: Placebo Comparator; Vehicle Ophthalmic Solution administered for six weeks (QID for four weeks then BID for two weeks).; Drug: Placebo Comparator; Vehicle Ophthalmic Solution administered for one year (QID for four weeks then BID for 11 months).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Treatment-Emergent Serious Adverse Events (TE-SAEs) of Visual Acuity Decrease	The proportion of 6-week safety population subjects that experience at least one visual acuity TE-SAE decrease (defined as an increase of 0.22 or greater in logMAR score) categorized as probably or definitely related to test article.	Safety assessment period (six weeks)
TE-SAEs of Increase in Intraocular Pressure	The proportion of 6-week safety population subjects that experience at least one intraocular pressure TE-SAE (increase from baseline of greater than or equal to 10 mmHg and intraocular pressure of greater than 25 mmHg) categorized as probably or definitely related to test article.	Safety assessment period (six weeks)
TE-SAEs of the Cornea	The proportion of 6-week safety population subjects that experience at least one cornea-related TE-SAE (detected via slit-lamp examination) categorized as probably or definitely related to test article.	Safety assessment period (six weeks)
TE-SAEs of the Retina	The proportion 6-week safety population subjects that experience at least one retinal TE-SAE (detected via fundoscopy) categorized as probably or definitely related to test article.	Safety assessment period (six weeks)
TE-SAEs of Visual Acuity Decrease	The proportion of 12-month safety population subjects that experience at least one visual acuity TE-SAE (defined as an increase of 0.22 or greater in logMAR score) categorized as probably or definitely related to test article.	Safety assessment period (12 months)
TE-SAEs of Increase in Intraocular Pressure	The proportion of 12-month safety population subjects that experience at least one intraocular pressure TE-SAE (increase from baseline of greater than or equal to 10 mmHg and intraocular pressure of greater than 25 mmHg) categorized as probably or definitely related to test article.	Safety assessment period (12 months)
TE-SAEs of the Cornea	The proportion of 12-month safety population subjects that experience at least one cornea-related TE-SAE (detected via slit-lamp examination) categorized as probably or definitely related to test article.	Safety assessment period (12 months)
TE-SAEs of the Retina	The proportion 12-month safety population subjects that experience at least one retinal TE-SAE(detected via fundoscopy) categorized as probably or definitely related to test article.	Safety assessment period (12-months)

Collaborators and Investigators

• Sponsor: Aldeyra Therapeutics, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): January 26, 2021
• Primary Completion (Actual): October 11, 2022
• Study Completion (Actual): October 11, 2022

Study Registration Dates

• First Submitted: January 25, 2021
• First Submitted That Met QC Criteria: February 1, 2021
• First Posted (Actual): February 3, 2021

Study Record Updates

• Last Update Posted (Actual): November 26, 2025
• Last Update Submitted That Met QC Criteria: November 14, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Lacrimal Apparatus Diseases; Dry Eye Syndromes; Pharmaceutical Solutions; Ophthalmic Solutions
• Other Study ID Numbers: ADX-102-DED-021

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No