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

Primary Purpose

Dry Eye

Status
Completed
Phase
Phase 2
Locations
Canada
Study Type
Interventional
Intervention
Reproxalap Ophthalmic Solution (0.25%)
Xiidra® (5% lifitegrast ophthalmic solution)
Sponsored by
Aldeyra Therapeutics, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dry Eye

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Cliantha Research

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Reproxalap Ophthalmic Solution (0.25%)

Xiidra® (5% lifitegrast ophthalmic solution)

Arm Description

Single dose

Single dose

Outcomes

Primary Outcome Measures

Adverse Event (AE) Query
Collection of AEs during the trial

Secondary Outcome Measures

Full Information

First Posted
October 18, 2021
Last Updated
September 26, 2022
Sponsor
Aldeyra Therapeutics, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT05102409
Brief Title
An Exploratory Clinical Trial to Assess Safety and Tolerability in Subjects With Dry Eye Disease
Official 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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2021
Overall Recruitment Status
Completed
Study Start Date
September 9, 2021 (Actual)
Primary Completion Date
October 25, 2021 (Actual)
Study Completion Date
October 25, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Aldeyra Therapeutics, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dry Eye

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Non-Randomized
Enrollment
56 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Reproxalap Ophthalmic Solution (0.25%)
Arm Type
Experimental
Arm Description
Single dose
Arm Title
Xiidra® (5% lifitegrast ophthalmic solution)
Arm Type
Active Comparator
Arm Description
Single dose
Intervention Type
Drug
Intervention Name(s)
Reproxalap Ophthalmic Solution (0.25%)
Intervention Description
Reproxalap Ophthalmic Solution (0.25%) dosed once
Intervention Type
Drug
Intervention Name(s)
Xiidra® (5% lifitegrast ophthalmic solution)
Intervention Description
Xiidra® (5% lifitegrast ophthalmic solution) dosed once
Primary Outcome Measure Information:
Title
Adverse Event (AE) Query
Description
Collection of AEs during the trial
Time Frame
Through trial completion, approximately four weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Cliantha Research
City
Mississauga
State/Province
Ontario
Country
Canada

12. IPD Sharing Statement

Learn more about this trial

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

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