Clinical trial

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

Name

A197-CS-201

Description

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.

Trial arms

Trial start

2022-01-25

Estimated PCD

2023-01-24

Trial end

2023-01-24

Status

Completed

Phase

Early phase I

Treatment

A197 Ophthalmic Solution

Arms:

A197 Ophthalmic Solution, High Dose, A197 Ophthalmic Solution, Low Dose

A197 Vehicle Control

Arms:

A197 Vehicle Control

Active Comparator

Arms:

Active Comparator

Size

207

Primary endpoint

Change from baseline in total corneal fluorescein staining (CFS)

12 Weeks

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

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}}, 'enrollmentInfo': {'count': 207, 'type': 'ACTUAL'}}

Updated at

2023-05-16

1 organization

2 products

1 indication

Organization

Product

Indication

Product