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A Clinical Trial to Evaluate the Safety and Efficacy of Rreproxalap in Adults With Dry Eye Disease

Primary Purpose

Dry Eye Syndromes

Status

Completed

Phase

Phase 2

Locations

Canada

Study Type

Interventional

Intervention

Reproxalap Ophthalmic Solution (0.25%)

Vehicle Ophthalmic Solution

About this trial

This is an interventional treatment trial for Dry Eye Syndromes focused on measuring dry eye disease, reproxalap, Aldeyra, ADX-102

Eligibility Criteria

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

Inclusion Criteria:

Eighteen (18) to 70 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 screening
Reported history of the use of eye drops for dry eye disease between 2 weeks to 6 months prior to screening

Exclusion Criteria:

Diagnosis of an ongoing ocular infection (bacterial, viral, or fungal), active ocular inflammation, or history of inflammatory disease (that, in the opinion of the Investigator, could interfere with study conduct or assessments) at screening
Contact lens use within 7 days of screening or anticipate using contact lenses during the trial
Systemic corticosteroid or other immunomodulatory therapy (not including inhaled corticosteroids) within 60 days of screening, or any planned immunomodulatory therapy throughout the study period
Women of childbearing potential (WOCBP) who are pregnant and nursing
If participant is of childbearing potential (female or male), unwillingness to use an acceptable means of birth control.
Known allergy and/or sensitivity to reproxalap or the drug product vehicle
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

Sites / Locations

Cliantha Research

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Reproxalap Ophthalmic Solution (0.25%)

Vehicle Ophthalmic Solution

Arm Description

Outcomes

Primary Outcome Measures

Change from baseline in conjunctival redness in a dry eye chamber

Conjunctival redness assessed on a 9 point scale using half unit increments using the modified Validated Bulbar Redness scale (0 None (better) - 4 Extremely Severe (worse))

Schirmer's test mean change from baseline

Assessed using a sterile Schirmer's test strip

Secondary Outcome Measures

Schirmer's test ≥10mm responder analysis of change from baseline

Assessed using a sterile Schirmer's test strip

Full Information

NCT ID

NCT05424549

First Posted

June 15, 2022

Last Updated

October 25, 2022

Sponsor

Aldeyra Therapeutics, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT05424549

Brief Title

A Clinical Trial to Evaluate the Safety and Efficacy of Rreproxalap in Adults With Dry Eye Disease

Official Title

A Randomized, Double-Masked, Vehicle-Controlled Crossover Clinical Trial to Assess Efficacy and Safety of 0.25% Reproxalap Ophthalmic Solution Compared to Vehicle in Subjects With Dry Eye Disease

Study Type

Interventional

2. Study Status

Record Verification Date

June 2022

Overall Recruitment Status

Completed

Study Start Date

March 9, 2022 (Actual)

Primary Completion Date

May 9, 2022 (Actual)

Study Completion Date

May 9, 2022 (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

Data Monitoring Committee

5. Study Description

Brief Summary

A Randomized, Double-Masked, Vehicle-Controlled Crossover Clinical Trial to Assess Efficacy and Safety of 0.25% Reproxalap Ophthalmic Solution Compared to Vehicle in Subjects with Dry Eye Disease

6. Conditions and Keywords

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

Dry Eye Syndromes

Keywords

dry eye disease, reproxalap, Aldeyra, ADX-102

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Crossover Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

63 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Reproxalap Ophthalmic Solution (0.25%)

Arm Type

Experimental

Arm Title

Vehicle Ophthalmic Solution

Arm Type

Placebo Comparator

Intervention Type

Drug

Intervention Name(s)

Reproxalap Ophthalmic Solution (0.25%)

Intervention Description

Reproxalap Ophthalmic Solution (0.25%) dosed six times over two consecutive days

Intervention Type

Drug

Intervention Name(s)

Vehicle Ophthalmic Solution

Intervention Description

Vehicle Ophthalmic Solution dosed six times over two consecutive days

Primary Outcome Measure Information:

Title

Change from baseline in conjunctival redness in a dry eye chamber

Description

Conjunctival redness assessed on a 9 point scale using half unit increments using the modified Validated Bulbar Redness scale (0 None (better) - 4 Extremely Severe (worse))

Time Frame

On the second day of two consecutive dosing days for both crossover periods

Title

Schirmer's test mean change from baseline

Description

Assessed using a sterile Schirmer's test strip

Time Frame

On the first day of two consecutive dosing days for both crossover periods

Secondary Outcome Measure Information:

Title

Schirmer's test ≥10mm responder analysis of change from baseline

Description

Assessed using a sterile Schirmer's test strip

Time Frame

On the first day of two consecutive dosing days for both crossover periods

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Eighteen (18) to 70 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 screening Reported history of the use of eye drops for dry eye disease between 2 weeks to 6 months prior to screening Exclusion Criteria: Diagnosis of an ongoing ocular infection (bacterial, viral, or fungal), active ocular inflammation, or history of inflammatory disease (that, in the opinion of the Investigator, could interfere with study conduct or assessments) at screening Contact lens use within 7 days of screening or anticipate using contact lenses during the trial Systemic corticosteroid or other immunomodulatory therapy (not including inhaled corticosteroids) within 60 days of screening, or any planned immunomodulatory therapy throughout the study period Women of childbearing potential (WOCBP) who are pregnant and nursing If participant is of childbearing potential (female or male), unwillingness to use an acceptable means of birth control. Known allergy and/or sensitivity to reproxalap or the drug product vehicle 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

ZIP/Postal Code

L4W 1A4

Country

Canada

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

A Clinical Trial to Evaluate the Safety and Efficacy of Rreproxalap in Adults With Dry Eye Disease

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