A Phase 2, Multicenter, Double-Masked, Randomized, Vehicle-Controlled Clinical Trial Evaluating the Safety, Tolerability, and Efficacy of A197 in Subjects With Dry Eye Disease
Overview
- Phase
- Phase 2
- Intervention
- A197 Ophthalmic Solution
- Conditions
- Dry Eye Disease
- Sponsor
- Aramis Biosciences, Inc.
- Enrollment
- 207
- Locations
- 24
- Primary Endpoint
- Change from baseline in total corneal fluorescein staining (CFS)
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
The objectives of this trial are to assess the safety, tolerability and efficacy of A197 ophthalmic solution in comparison to a vehicle control in the treatment of subjects with Dry Eye Disease.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Written informed consent must be obtained prior to any study-related assessments
- •Have a history of Dry Eye Disease in both eyes for at least 12 months prior to Visit 1
- •Willing and able to follow instructions and can be present for required study visits
Exclusion Criteria
- •Women who are pregnant or breastfeeding
- •Use of topical ophthalmic medications, artificial tears, eye drops and gels in either eye
- •Use of contact lenses within 90 days prior to Visit 1 and throughout the study
- •Have had an ocular infection in either eye within 90 days prior to Visit 1
Arms & Interventions
A197 Ophthalmic Solution, Low Dose
Intervention: A197 Ophthalmic Solution
A197 Ophthalmic Solution, High Dose
Intervention: A197 Ophthalmic Solution
A197 Vehicle Control
Intervention: A197 Vehicle Control
Active Comparator
Intervention: Active Comparator
Outcomes
Primary Outcomes
Change from baseline in total corneal fluorescein staining (CFS)
Time Frame: 12 Weeks
Corneal Fluorescein Staining (tCFS) is graded based on a modified National Eye Institute (NEI) scale. The NEI scale divides the cornea in 5 regions: central, inferior, superior, nasal, temporal. The score for each region ranges from 0-4 using 0.5 unit increments; 0 corresponds to no staining, 4 corresponds to maximum staining. The total score is the sum of the 5 regions ranging from 0-20.
Secondary Outcomes
- Change from baseline in bulbar conjunctival hyperemia (CCLRU)(12 Weeks)
- Change from baseline in eye dryness via the Visual Analogue Scale (VAS)(12 Weeks)
- Change from baseline in lissamine green conjunctival staining (LGCS)(12 Weeks)