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

NCT04735393 | Completed Phase 3 Results FDA Drug

• 1 other identifier: ADX-102-DED-021
• Study Type: interventional
• Target: 757
• Locations: 1 country
• Sites: 1

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

Conditions

Dry Eye Disease

Outcome Measures

Primary Outcomes (8)

• 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)

Study Arms (4)

Reproxalap (0.25%) for six weeks

EXPERIMENTAL

Reproxalap four times daily (QID) for four weeks followed by two times daily (BID) for two weeks

Drug: Reproxalap Ophthalmic Solution (0.25%)

Vehicle for six weeks

PLACEBO COMPARATOR

Vehicle QID for four weeks followed by BID for two weeks

Drug: Placebo Comparator

Reproxalap (0.25%) for 12 months

EXPERIMENTAL

Reproxalap (0.25%) QID for four weeks followed by BID for 11 months

Drug: Reproxalap Ophthalmic Solution (0.25%)

Vehicle for 12 months

PLACEBO COMPARATOR

Vehicle QID for four weeks followed by BID for 11 months

Drug: Placebo Comparator

Interventions

Reproxalap Ophthalmic Solution (0.25%) DRUG

Reproxalap Ophthalmic Solution (0.25%) administered for six weeks (QID for four weeks then BID for two weeks).

Reproxalap (0.25%) for six weeks

Placebo Comparator DRUG

Vehicle Ophthalmic Solution administered for six weeks (QID for four weeks then BID for two weeks).

Vehicle for six weeks

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Aldeyra Therapeutics, Inc.: lead

Study Sites (1)

Andover Eye Associates

Andover, Massachusetts, 01810, United States

Location

MeSH Terms

Conditions

Dry Eye Syndromes

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases

Results Point of Contact

• Title: Director of Clinical Trials
• Organization: Aldeyra Therapeutics, Inc.

bcavanagh@aldeyra.com

781-257-3063

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 25, 2021
• First Posted: February 3, 2021
• Study Start: January 26, 2021
• Primary Completion: October 11, 2022
• Study Completion: October 11, 2022
• Last Updated: November 26, 2025
• Results First Posted: November 26, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)