An Exploratory Crossover Clinical Trial to Compare the Activity of Reproxalap and Lifitegrast in a Dry Eye Disease Chamber

NCT05102409 | Completed Phase 2 Results FDA Drug

• 1 other identifier: ADX-102-DED-025
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

Brief Summary

An Exploratory, Single-Center, Double-Masked, Crossover Clinical Trial to Assess Safety and Tolerability of 0.25% Reproxalap Ophthalmic Solution Compared to Xiidra® in Subjects with Dry Eye Disease in a Dry Eye Chamber

Conditions

Dry Eye

Outcome Measures

Primary Outcomes (2)

• Change From Baseline in Ocular Discomfort

  Ocular discomfort (0 = none, 10 = extremely severe) was reported by patients in a dry eye chamber. Change from baseline was analyzed using a mixed model repeated measures (MMRM) analysis, with baseline as a covariate, and treatment and intra-chamber time point as factors.

  The efficacy assessment period was approximately every 5 minutes during a 45-minute dry eye chamber. Baseline was prior to dosing for each treatment period.

• Change From Baseline in Ocular Itching

  Ocular itching (0 = none, 10 = extremely severe) was reported by patients in a dry eye chamber. Change from baseline was analyzed using a MMRM analysis, with baseline as a covariate, and treatment and intra-chamber time point as factors.

  The efficacy assessment period was approximately every 5 minutes during a 45-minute dry eye chamber. Baseline was prior to dosing for each treatment period.

Study Arms (2)

Reproxalap Ophthalmic Solution (0.25%)

EXPERIMENTAL

Single dose

Drug: Reproxalap Ophthalmic Solution (0.25%)

Xiidra® (5% lifitegrast ophthalmic solution)

ACTIVE COMPARATOR

Single dose

Drug: Xiidra® (5% lifitegrast ophthalmic solution)

Interventions

Reproxalap Ophthalmic Solution (0.25%) DRUG

Reproxalap Ophthalmic Solution (0.25%) dosed once

Reproxalap Ophthalmic Solution (0.25%)

Xiidra® (5% lifitegrast ophthalmic solution) DRUG

Xiidra® (5% lifitegrast ophthalmic solution) dosed once

Xiidra® (5% lifitegrast 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) to70 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 Visit 1.

You may not qualify if:

• 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.
• 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, Canada

Location

MeSH Terms

Conditions

Dry Eye Syndromes

Interventions

lifitegrast

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 2
• Allocation: NON 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: October 18, 2021
• First Posted: November 1, 2021
• Study Start: September 9, 2021
• Primary Completion: October 25, 2021
• Study Completion: October 25, 2021
• Last Updated: February 28, 2025
• Results First Posted: February 28, 2025

Record last verified: 2021-10

Locations

CA (1)