A Study to Evaluate the Safety, Tolerability, and Efficacy of A197 in Subjects With Dry Eye Disease

Aramis Biosciences

Status and phase: Completed; Phase 2

Conditions: Dry Eye Disease

Treatments: Drug: Active Comparator; Drug: A197 Ophthalmic Solution; Drug: A197 Vehicle Control

Study type: Interventional

Funder types: Industry

Identifiers

NCT05238597

A197-CS-201

Details and patient eligibility

About

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.

Enrollment: 207 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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207 participants in 4 patient groups, including a placebo group

A197 Ophthalmic Solution, High Dose

Experimental group

Treatment:

Drug: A197 Ophthalmic Solution

A197 Ophthalmic Solution, Low Dose

Experimental group

Treatment:

Drug: A197 Ophthalmic Solution

A197 Vehicle Control

Placebo Comparator group

Treatment:

Drug: A197 Vehicle Control

Active Comparator

Active Comparator group

Treatment:

Drug: Active Comparator