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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

Sponsor
Aldeyra Therapeutics, Inc. (Industry)
Overall Status
Recruiting
CT.gov ID
NCT04735393
Collaborator
(none)
525
Enrollment
1
Location
4
Arms
17.1
Anticipated Duration (Months)
30.7
Patients Per Site Per Month

Study Details

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

Condition or Disease Intervention/Treatment Phase
  • Drug: Reproxalap Ophthalmic Solution (0.25%)
  • Drug: Placebo Comparator
  • Drug: Reproxalap Ophthalmic Solution (0.25%)
  • Drug: Placebo Comparator
 Phase 3

Study Design

Study Type:
Interventional
Anticipated Enrollment :
525 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
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
Actual Study Start Date :
Jan 26, 2021
Anticipated Primary Completion Date :
Jun 30, 2022
Anticipated Study Completion Date :
Jun 30, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: Reproxalap Ophthalmic Solution (0.25%) QID for four weeks followed by BID for two weeks.

Drug: Reproxalap Ophthalmic Solution (0.25%)
Reproxalap Ophthalmic Solution (0.25%) administered for six weeks (QID for four weeks then BID for two weeks).
Placebo Comparator: Vehicle Ophthalmic Solution QID for four weeks followed by BID for two weeks.

Drug: Placebo Comparator
Vehicle Ophthalmic Solution administered for six weeks (QID for four weeks then BID for two weeks).
Experimental: Reproxalap Ophthalmic Solution (0.25%) QID for four weeks followed by BID for 11 months.

Drug: Reproxalap Ophthalmic Solution (0.25%)
Reproxalap Ophthalmic Solution (0.25%) administered for one year (QID for four weeks then BID for 11 months).
Placebo Comparator: Vehicle Ophthalmic Solution QID for four weeks followed by BID for 11 months.

Drug: Placebo Comparator
Vehicle Ophthalmic Solution administered for one year (QID for four weeks then BID for 11 months).

Outcome Measures

Primary Outcome Measures

  1. Ocular treatment emergent adverse events (TEAEs) [Safety assessment period (Day 1 through Day 28 or Day 1 through Day 360)]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Andover Eye Associates Andover Massachusetts United States 01810

Sponsors and Collaborators

  • Aldeyra Therapeutics, Inc.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Aldeyra Therapeutics, Inc.
ClinicalTrials.gov Identifier:
NCT04735393
Other Study ID Numbers:
  • ADX-102-DED-021
First Posted:
Feb 3, 2021
Last Update Posted:
Feb 10, 2022
Last Verified:
Feb 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Dry Eye Syndromes
Keratoconjunctivitis Sicca
Eye Diseases
Pharmaceutical Solutions
Ophthalmic Solutions

Study Results

No Results Posted as of Feb 10, 2022