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A Multi-Center, Double-Masked, Randomized, Vehicle-Controlled, Parallel-Group Clinical Trial Evaluating the Safety of Reproxalap Ophthalmic Solution in Subjects With Dry Eye Disease

Primary Purpose

Dry Eye Disease

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Reproxalap Ophthalmic Solution (0.25%)
Placebo Comparator
Reproxalap Ophthalmic Solution (0.25%)
Placebo Comparator
Sponsored by
Aldeyra Therapeutics, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dry Eye Disease

Eligibility Criteria

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

Inclusion Criteria:

  • 18 years of age (either gender and any race);
  • Reported history of dry eye for at least 6 months prior to Visit 1;
  • History of use or desire to use eye drops for dry eye symptoms within 6 months of Visit 1.

Exclusion Criteria:

  • Clinically significant slit lamp findings at Visit 1 that may include active blepharitis, meibomian gland dysfunction (MGD), lid margin inflammation, or active ocular allergies that require therapeutic treatment, and/or in the opinion of the investigator may interfere with study parameters;
  • 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;
  • Eye drop use within 2 hours of Visit 1;
  • Previous laser-assisted in situ keratomileusis (LASIK) surgery within the last 12 months;
  • Cyclosporine 0.05% or 0.09% or lifitegrast 5.0% ophthalmic solution within 90 days of Visit 1;
  • Planned ocular and/or lid surgeries over the study period or any ocular surgery within 6 months of Visit 1;
  • Temporary punctal plugs during the study that have not been stable within 30 days of Visit 1.

Sites / Locations

  • Andover Eye Associates

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Placebo Comparator

Experimental

Placebo Comparator

Arm Label

Reproxalap Ophthalmic Solution (0.25%) QID for four weeks followed by BID for two weeks.

Vehicle Ophthalmic Solution QID for four weeks followed by BID for two weeks.

Reproxalap Ophthalmic Solution (0.25%) QID for four weeks followed by BID for 11 months.

Vehicle Ophthalmic Solution QID for four weeks followed by BID for 11 months.

Arm Description

Outcomes

Primary Outcome Measures

Ocular treatment emergent adverse events (TEAEs)
Percentages of subjects with ocular treatment-emergent adverse events (TEAEs).

Secondary Outcome Measures

Full Information

First Posted
January 25, 2021
Last Updated
May 31, 2023
Sponsor
Aldeyra Therapeutics, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT04735393
Brief Title
A Multi-Center, Double-Masked, Randomized, Vehicle-Controlled, Parallel-Group Clinical Trial Evaluating the Safety of Reproxalap Ophthalmic Solution in Subjects With Dry Eye Disease
Official Title
A Multi-Center, Double-Masked, Randomized, Vehicle-Controlled, Parallel-Group Clinical Trial Evaluating the Safety of 0.25% Reproxalap Ophthalmic Solution in Subjects With Dry Eye Disease
Study Type
Interventional

2. Study Status

Record Verification Date
February 2022
Overall Recruitment Status
Completed
Study Start Date
January 26, 2021 (Actual)
Primary Completion Date
October 11, 2022 (Actual)
Study Completion Date
October 11, 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
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
A Multi-Center, Double-Masked, Randomized, Vehicle-Controlled, Parallel-Group Clinical Trial Evaluating the Safety of 0.25% Reproxalap Ophthalmic Solution 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 Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
757 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Reproxalap Ophthalmic Solution (0.25%) QID for four weeks followed by BID for two weeks.
Arm Type
Experimental
Arm Title
Vehicle Ophthalmic Solution QID for four weeks followed by BID for two weeks.
Arm Type
Placebo Comparator
Arm Title
Reproxalap Ophthalmic Solution (0.25%) QID for four weeks followed by BID for 11 months.
Arm Type
Experimental
Arm Title
Vehicle Ophthalmic Solution QID for four weeks followed by BID for 11 months.
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Reproxalap Ophthalmic Solution (0.25%)
Intervention Description
Reproxalap Ophthalmic Solution (0.25%) administered for six weeks (QID for four weeks then BID for two weeks).
Intervention Type
Drug
Intervention Name(s)
Placebo Comparator
Intervention Description
Vehicle Ophthalmic Solution administered for six weeks (QID for four weeks then BID for two weeks).
Intervention Type
Drug
Intervention Name(s)
Reproxalap Ophthalmic Solution (0.25%)
Intervention Description
Reproxalap Ophthalmic Solution (0.25%) administered for one year (QID for four weeks then BID for 11 months).
Intervention Type
Drug
Intervention Name(s)
Placebo Comparator
Intervention Description
Vehicle Ophthalmic Solution administered for one year (QID for four weeks then BID for 11 months).
Primary Outcome Measure Information:
Title
Ocular treatment emergent adverse events (TEAEs)
Description
Percentages of subjects with ocular treatment-emergent adverse events (TEAEs).
Time Frame
Safety assessment period (Day 1 through Day 28 or Day 1 through Day 360)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 18 years of age (either gender and any race); Reported history of dry eye for at least 6 months prior to Visit 1; History of use or desire to use eye drops for dry eye symptoms within 6 months of Visit 1. Exclusion Criteria: Clinically significant slit lamp findings at Visit 1 that may include active blepharitis, meibomian gland dysfunction (MGD), lid margin inflammation, or active ocular allergies that require therapeutic treatment, and/or in the opinion of the investigator may interfere with study parameters; 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; Eye drop use within 2 hours of Visit 1; Previous laser-assisted in situ keratomileusis (LASIK) surgery within the last 12 months; Cyclosporine 0.05% or 0.09% or lifitegrast 5.0% ophthalmic solution within 90 days of Visit 1; Planned ocular and/or lid surgeries over the study period or any ocular surgery within 6 months of Visit 1; Temporary punctal plugs during the study that have not been stable within 30 days of Visit 1.
Facility Information:
Facility Name
Andover Eye Associates
City
Andover
State/Province
Massachusetts
ZIP/Postal Code
01810
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

A Multi-Center, Double-Masked, Randomized, Vehicle-Controlled, Parallel-Group Clinical Trial Evaluating the Safety of Reproxalap Ophthalmic Solution in Subjects With Dry Eye Disease

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