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OpenTrials
Completed

NCT Number: NCT05102409

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

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

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Key information

Conditions

Dry Eye Dry Eye Syndromes Eye Diseases Lacrimal Apparatus Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Cliantha Research

Mississauga, Ontario, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Reproxalap ophthalmic solution (0.25%)

Drug

Reproxalap Ophthalmic Solution (0.25%) dosed once

Xiidra® (5% lifitegrast ophthalmic solution)

Drug

Xiidra® (5% lifitegrast ophthalmic solution) dosed once

Primary outcomes

  1. Change From Baseline in Ocular Discomfort

    Time frame: 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.

  2. Change From Baseline in Ocular Itching

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Aldeyra Therapeutics, Inc.

Industry

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Nov 1, 2021
Registry last updated
Feb 28, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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