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

Phase 2

Completed

• Conditions: Dry Eye
• Interventions: Drug: Reproxalap Ophthalmic Solution (0.25%); Drug: Xiidra® (5% lifitegrast ophthalmic solution)

• Registration Number: NCT05102409
• Lead Sponsor: Aldeyra Therapeutics, Inc.

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

Detailed Description

Not available

Study Timeline

• Study Start: 2021-09-09
• Status Verified: 2021-10
• Study First Submitted: 2021-10-18
• Primary Completion: 2021-10-25
• Study Completion: 2021-10-25
• Study First Submitted QC: 2021-10-28
• Study First Posted: 2021-11-01
• Disposition First Submitted: 2022-09-26
• Results First Submitted: 2025-02-04
• Results First Submitted QC: 2025-02-24
• Last Update Submitted: 2025-02-24
• Results First Posted: 2025-02-28
• Disposition First Posted: 2025-02-28
• Last Update Posted: 2025-02-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 56

Inclusion Criteria

1. Eighteen (18) to70 years of age at the time of screening (either gender and any race).
2. Ability to provide written informed consent.
3. Reported history of dry eye for at least 6 months prior to Visit 1.

Exclusion Criteria

1. Diagnosis of an ongoing ocular infection (bacterial, viral, or fungal) or active ocular inflammation at Visit 1.
2. Contact lens use within 7 days of Visit 1 or anticipate using contact lenses during the trial.
3. 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.
4. Inability or unwillingness to follow instructions, including participation in all study assessments/procedures and visits.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Reproxalap Ophthalmic Solution (0.25%)	Reproxalap Ophthalmic Solution (0.25%)	Single dose
Xiidra® (5% lifitegrast ophthalmic solution)	Xiidra® (5% lifitegrast ophthalmic solution)	Single dose

Primary Outcome Measures

Name	Time	Method
Change From Baseline in Ocular Discomfort	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.	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.
Change From Baseline in Ocular Itching	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.	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.

Trial Locations

Locations (1)

Cliantha Research; 🇨🇦 Mississauga, Ontario, Canada