A Clinical Trial to Evaluate the Safety and Efficacy of Rreproxalap in Adults With Dry Eye Disease

NCT05424549 | Completed Phase 2 Results FDA Drug

• 1 other identifier: ADX-102-DED-027
• Study Type: interventional
• Target: 63
• Locations: 1 country
• Sites: 1

Brief Summary

A Randomized, Double-Masked, Vehicle-Controlled Crossover Clinical Trial to Assess Efficacy and Safety of 0.25% Reproxalap Ophthalmic Solution Compared to Vehicle in Subjects with Dry Eye Disease

Conditions

Dry Eye Syndromes

Keywords

dry eye disease; reproxalap; Aldeyra; ADX-102

Outcome Measures

Primary Outcomes (2)

• Conjunctival Redness Assessed Via Digital Photography Over 90 Minutes in the Dry Eye Chamber

  Change from baseline comparison of reproxalap to vehicle for conjunctival redness assessed on a 0 to 4 scale (0 = none, 4 = extremely severe). The least squares mean (95% confidence interval) was derived from mixed model repeated measure for change from baseline included baseline as a covariate, and treatment, period, sequence, and time point as factors.

  The efficacy assessment period was during a 90-minute dry eye chamber; baseline was pre-dose #1 for each treatment period.

• Schirmer Test Mean Change From Baseline

  Change from baseline comparison of reproxalap to vehicle for schirmer test on a millimeter line (0 = none, 35 = maximum). The least squares mean (95% confidence interval) was derived from mixed model repeated measure for change from baseline included baseline as a covariate, and treatment, period, sequence, and time point as factors.

  The efficacy assessment period was assessed on the first day of two consecutive dosing days for both crossover periods; baseline was pre-dose #1 for each treatment period.

Study Arms (2)

Reproxalap Ophthalmic Solution (0.25%)

EXPERIMENTAL

Drug: Reproxalap Ophthalmic Solution (0.25%)

Vehicle Ophthalmic Solution

PLACEBO COMPARATOR

Drug: Vehicle Ophthalmic Solution

Interventions

Reproxalap Ophthalmic Solution (0.25%) DRUG

Reproxalap Ophthalmic Solution (0.25%) dosed six times over two consecutive days

Reproxalap Ophthalmic Solution (0.25%)

Vehicle Ophthalmic Solution DRUG

Vehicle Ophthalmic Solution dosed six times over two consecutive days

Vehicle Ophthalmic Solution

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Eighteen (18) to 70 years of age at the time of screening (either gender and any race)
• Ability to provide written informed consent
• Reported history of dry eye for at least 6 months prior to screening
• Reported history of the use of eye drops for dry eye disease between 2 weeks to 6 months prior to screening

You may not qualify if:

• Diagnosis of an ongoing ocular infection (bacterial, viral, or fungal), active ocular inflammation, or history of inflammatory disease (that, in the opinion of the Investigator, could interfere with study conduct or assessments) at screening
• Contact lens use within 7 days of screening or anticipate using contact lenses during the trial
• Systemic corticosteroid or other immunomodulatory therapy (not including inhaled corticosteroids) within 60 days of screening, or any planned immunomodulatory therapy throughout the study period
• Women of childbearing potential (WOCBP) who are pregnant and nursing
• If participant is of childbearing potential (female or male), unwillingness to use an acceptable means of birth control.
• Known allergy and/or sensitivity to reproxalap or the drug product vehicle
• A condition that the investigator feels may put the subject at significant risk, may confound the study results, or may interfere significantly with the subject's participation in the trial
• Inability or unwillingness to follow instructions, including participation in all study assessments/procedures and visits

Sponsors & Collaborators

• Aldeyra Therapeutics, Inc.: lead

Study Sites (1)

Cliantha Research

Mississauga, Ontario, L4W 1A4, Canada

Location

Related Publications (1)

• Mangwani-Mordani S, Goodman CF, Galor A. Novel Treatments for Chronic Ocular Surface Pain. Cornea. 2023 Mar 1;42(3):261-271. doi: 10.1097/ICO.0000000000003193. Epub 2022 Dec 19.

  PMID: 36729473 DERIVED

MeSH Terms

Conditions

Dry Eye Syndromes

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases

Results Point of Contact

• Title: Bill Cavanagh
• 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 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 15, 2022
• First Posted: June 21, 2022
• Study Start: March 9, 2022
• Primary Completion: May 9, 2022
• Study Completion: May 9, 2022
• Last Updated: January 15, 2025
• Results First Posted: January 15, 2025

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)