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

Phase 2

Completed

• Conditions: Dry Eye Disease
• Interventions: Drug: A197 Ophthalmic Solution; Drug: Active Comparator; Drug: A197 Vehicle Control

• Registration Number: NCT05238597
• Lead Sponsor: Aramis Biosciences, Inc.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-01-25
• Study First Submitted: 2022-02-03
• Study First Submitted QC: 2022-02-11
• Study First Posted: 2022-02-14
• Primary Completion: 2023-01-24
• Study Completion: 2023-01-24
• Status Verified: 2023-05
• Last Update Submitted: 2023-05-15
• Last Update Posted: 2023-05-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 207

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
A197 Ophthalmic Solution, High Dose	A197 Ophthalmic Solution	-
Active Comparator	Active Comparator	-
A197 Ophthalmic Solution, Low Dose	A197 Ophthalmic Solution	-
A197 Vehicle Control	A197 Vehicle Control	-

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.
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.

Trial Locations

Locations (24)

Aramis Site 113; 🇺🇸 Birmingham, Alabama, United States

Aramis Site 124; 🇺🇸 Los Angeles, California, United States

Aramis Site 102; 🇺🇸 Newport Beach, California, United States

Aramis Site 101; 🇺🇸 Delray Beach, Florida, United States

Aramis Site 105; 🇺🇸 San Antonio, Texas, United States

Aramis Site 103; 🇺🇸 Memphis, Tennessee, United States

Aramis Site 108; 🇺🇸 Las Vegas, Nevada, United States

Aramis Site 115; 🇺🇸 Goodlettsville, Tennessee, United States

Aramis Site 121; 🇺🇸 Garden Grove, California, United States

Aramis Site 106; 🇺🇸 Long Beach, California, United States

Aramis Site 120; 🇺🇸 Glendale, California, United States

Aramis Site 107; 🇺🇸 Murrieta, California, United States

Aramis Site 116; 🇺🇸 Petaluma, California, United States

Aramis Site 109; 🇺🇸 Rancho Cordova, California, United States

Aramis Site 112; 🇺🇸 Jacksonville, Florida, United States

Aramis Site 114; 🇺🇸 Kansas City, Missouri, United States

Aramis Site 117; 🇺🇸 Largo, Florida, United States

Aramis Site 118; 🇺🇸 Edgewood, Kentucky, United States

Aramis Site 110; 🇺🇸 Garner, North Carolina, United States

Aramis Site 111; 🇺🇸 Saint Louis, Missouri, United States

Aramis Site 122; 🇺🇸 Shelby, North Carolina, United States

Aramis Site 119; 🇺🇸 Mason, Ohio, United States

Aramis Site 123; 🇺🇸 Cranberry Township, Pennsylvania, United States

Aramis Site 104; 🇺🇸 Lakeway, Texas, United States