An Exploratory Clinical Trial to Assess Safety and Tolerability in Subjects With Dry Eye Disease

Sponsor

Aldeyra Therapeutics, Inc. (Industry)

Overall Status

Completed

CT.gov ID

NCT05102409

Collaborator

(none)

Enrollment

Location

Arms

1.5

Actual Duration (Months)

37.1

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Dry Eye	Drug: Reproxalap Ophthalmic Solution (0.25%) Drug: Xiidra® (5% lifitegrast ophthalmic solution)	Phase 2

Study Design

Study Type:

Interventional

Actual Enrollment :

56 participants

Allocation:

Non-Randomized

Intervention Model:

Crossover Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

Actual Study Start Date :

Sep 9, 2021

Actual Primary Completion Date :

Oct 25, 2021

Actual Study Completion Date :

Oct 25, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Reproxalap Ophthalmic Solution (0.25%) Single dose	Drug: Reproxalap Ophthalmic Solution (0.25%) Reproxalap Ophthalmic Solution (0.25%) dosed once
Active Comparator: Xiidra® (5% lifitegrast ophthalmic solution) Single dose	Drug: Xiidra® (5% lifitegrast ophthalmic solution) Xiidra® (5% lifitegrast ophthalmic solution) dosed once

Arm

Intervention/Treatment

Experimental: Reproxalap Ophthalmic Solution (0.25%)

Single dose

Drug: Reproxalap Ophthalmic Solution (0.25%)

Reproxalap Ophthalmic Solution (0.25%) dosed once

Active Comparator: Xiidra® (5% lifitegrast ophthalmic solution)

Single dose

Drug: Xiidra® (5% lifitegrast ophthalmic solution)

Xiidra® (5% lifitegrast ophthalmic solution) dosed once

Outcome Measures

Primary Outcome Measures

Adverse Event (AE) Query [Through trial completion, approximately four weeks]
Collection of AEs during the trial

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.