A Clinical Trial to Assess Subjects With Dry Eye Disease.

  • STATUS
    Recruiting
  • End date
    Dec 31, 2021
  • participants needed
    150
  • sponsor
    Aldeyra Therapeutics, Inc.
Updated on 29 July 2021

Summary

A Multi-Center Randomized, Double-Masked, Parallel Design, Vehicle-Controlled Phase 2 Clinical Trial to Assess the Efficacy and Safety of 0.25% Reproxalap Ophthalmic Solution Compared to Vehicle in Subjects with Dry Eye Disease

Details
Condition Dry eye syndrome, Keratoconjunctivitis Sicca, Dry Eyes, eye dryness, dry eye
Treatment Reproxalap Ophthalmic Solution (0.25%), Vehicle Ophthalmic Solution
Clinical Study IdentifierNCT04971031
SponsorAldeyra Therapeutics, Inc.
Last Modified on29 July 2021

Eligibility

Yes No Not Sure

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
Reported 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 use within 90 days of Visit 1
Be receiving systemic corticosteroid therapy (not including inhaled corticosteroids) within 14 days of Visit 1 or anticipate such therapy throughout the study period
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
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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