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

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05238597

Enrollment

207

Registered

2022-02-14

Start date

2022-01-25

Completion date

2023-01-24

Last updated

2023-05-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dry Eye Disease

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.

Interventions

DRUGA197 Ophthalmic Solution

A197 Ophthalmic Solution

DRUGA197 Vehicle Control

A197 Vehicle Control

DRUGActive Comparator

Active Comparator

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
Change from baseline in total corneal fluorescein staining (CFS)	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

Measure	Time frame	Description
Change from baseline in eye dryness via the Visual Analogue Scale (VAS)	12 Weeks	Eye dryness is rated on a visual analogue scale (VAS) ranging from 0-100; 0 corresponds to no symptoms and 100 to severe symptoms.
Change from baseline in lissamine green conjunctival staining (LGCS)	12 Weeks	Lissamine green conjunctival staining (LGCS) is graded based on the NEI Scale. The NEI scale divides the conjunctiva in 6 regions with the score for each region ranging from 0-3; 0 corresponds to no staining, 3 corresponds to maximum staining. The total score is the sum of the 6 regions ranging from 0-18.
Change from baseline in bulbar conjunctival hyperemia (CCLRU)	12 Weeks	Bulbar conjunctival hyperemia is graded based on the Cornea and Contact Lens Research Unit (CCLRU) grading scale where 0 corresponds to none, 4 corresponds to severe.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026