NCT06389214CompletedPhase 3
A Randomized, Double-Masked, Vehicle-Controlled Parallel Group Clinical Trial to Assess Efficacy and Safety of 0.25% Reproxalap Ophthalmic Solution Compared to Vehicle in Subjects With Dry Eye Disease
Aldeyra Therapeutics, Inc.1 site in 1 country132 target enrollmentStarted: April 9, 2024Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Aldeyra Therapeutics, Inc.
- Enrollment
- 132
- Locations
- 1
- Primary Endpoint
- Ocular discomfort symptom score over 100 minutes in the dry eye chamber at Visit 2 and Visit 4
Study Overview
Brief Summary
A Randomized, Double-Masked, Vehicle-Controlled Parallel Group Clinical Trial to Assess Efficacy and Safety of 0.25% Reproxalap Ophthalmic Solution Compared to Vehicle in Subjects with Dry Eye Disease
Detailed Description
Dry eye chamber challenge trial.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Eighteen to 70 years of age at the time of screening (either gender and any race)
- •Ability to provide written informed consent
- •Reported history of ocular discomfort associated with dry eye disease for at least 6 months prior to Visit 1
- •Reported history of the use of eye drops for dry eye disease between 2 weeks to 6 months prior to Visit 1
Exclusion Criteria
- •Clinically significant slit lamp findings, intraocular pressure, and visual acuity findings at Visit 2 that may include active blepharitis, severe meibomian gland dysfunction, lid margin inflammation, glaucoma, ocular allergy, infection or any other disorder that, in the opinion of the Investigator, may interfere with trial conduct or assessments
- •Diagnosis at Visit 1 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 trial conduct or assessments
- •Contact lens use within 7 days of Visit 1 or anticipated use of contact lenses during the trial
- •Laser-assisted in situ keratomileusis (LASIK) surgery within 12 months of Visit 1 and/or planned ocular and/or lid surgeries during the trial or any other ocular surgery within 6 months of Visit 1
- •Systemic corticosteroid or other immunomodulatory therapy (not including inhaled corticosteroids) within 60 days of Visit 1, or any planned immunomodulatory therapy during the trial
- •Eye drop use within 2 weeks of Visit 1 and/or an unwillingness to discontinue any topical ophthalmic prescription or over-the-counter solutions, artificial tears, gels, or scrubs for the duration of the trial (excluding medications allowed for the conduct of the trial)
Arms & Interventions
Reproxalap Ophthalmic Solution (0.25%) administered six times over two consecutive days
Experimental
Intervention: Reproxalap Ophthalmic Solution (0.25%) (Drug)
Vehicle Ophthalmic Solution administered six times over two consecutive days
Placebo Comparator
Intervention: Vehicle Ophthalmic Solution (Drug)
Outcomes
Primary Outcomes
Ocular discomfort symptom score over 100 minutes in the dry eye chamber at Visit 2 and Visit 4
Time Frame: From Day -14 to Day 2
Measured using a 0 - 100 visual analog scale (VAS) where 0 is "no discomfort" and 100 is "maximal discomfort"
Secondary Outcomes
No secondary outcomes reported
Investigators
Study Sites (1)
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