A Clinical Trial to Assess the Efficacy and Safety of Subjects With Dry Eye Disease

Dry Eye Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06389214
• Other study ID #: ADX-102-DED-030
• Status: Completed
• Phase: Phase 3
• Start date: April 9, 2024
• Est. completion date: June 11, 2024

Study information

• Verified date: June 2024
• Source: Aldeyra Therapeutics, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Description:

Dry eye chamber challenge trial.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 132
• Est. completion date: June 11, 2024
• Est. primary completion date: June 11, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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)

Related Conditions & MeSH terms

• Dry Eye Disease
• Dry Eye Syndromes
• Eye Diseases
• Keratoconjunctivitis Sicca

Intervention

Drug:
• Reproxalap Ophthalmic Solution (0.25%)
Reproxalap Ophthalmic Solution (0.25%) administered six times over two consecutive days
• Vehicle Ophthalmic Solution
Vehicle Ophthalmic Solution administered six times over two consecutive days

Locations

Country	Name	City	State
Canada	Cliantha Research	Mississauga	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Aldeyra Therapeutics, Inc.

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ocular discomfort symptom score over 100 minutes in the dry eye chamber at Visit 2 and Visit 4	Measured using a 0 - 100 visual analog scale (VAS) where 0 is "no discomfort" and 100 is "maximal discomfort"	From Day -14 to Day 2