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

Dry Eye Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05238597
• Other study ID #: A197-CS-201
• Status: Completed
• Phase: Phase 2
• Start date: January 25, 2022
• Est. completion date: January 24, 2023

Study information

• Verified date: May 2023
• Source: Aramis Biosciences, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 207
• Est. completion date: January 24, 2023
• Est. primary completion date: January 24, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Dry Eye Disease
• Dry Eye Syndromes
• Eye Diseases
• Keratoconjunctivitis Sicca

Intervention

Drug:
• A197 Ophthalmic Solution
A197 Ophthalmic Solution
• A197 Vehicle Control
A197 Vehicle Control
• Active Comparator
Active Comparator

Locations

Country	Name	City	State
United States	Aramis Site 113	Birmingham	Alabama
United States	Aramis Site 123	Cranberry Township	Pennsylvania
United States	Aramis Site 101	Delray Beach	Florida
United States	Aramis Site 118	Edgewood	Kentucky
United States	Aramis Site 121	Garden Grove	California
United States	Aramis Site 110	Garner	North Carolina
United States	Aramis Site 120	Glendale	California
United States	Aramis Site 115	Goodlettsville	Tennessee
United States	Aramis Site 112	Jacksonville	Florida
United States	Aramis Site 114	Kansas City	Missouri
United States	Aramis Site 104	Lakeway	Texas
United States	Aramis Site 117	Largo	Florida
United States	Aramis Site 108	Las Vegas	Nevada
United States	Aramis Site 106	Long Beach	California
United States	Aramis Site 124	Los Angeles	California
United States	Aramis Site 119	Mason	Ohio
United States	Aramis Site 103	Memphis	Tennessee
United States	Aramis Site 107	Murrieta	California
United States	Aramis Site 102	Newport Beach	California
United States	Aramis Site 116	Petaluma	California
United States	Aramis Site 109	Rancho Cordova	California
United States	Aramis Site 111	Saint Louis	Missouri
United States	Aramis Site 105	San Antonio	Texas
United States	Aramis Site 122	Shelby	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Aramis Biosciences, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in total corneal fluorescein staining (CFS)	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.	12 Weeks
Secondary	Change from baseline in eye dryness via the Visual Analogue Scale (VAS)	Eye dryness is rated on a visual analogue scale (VAS) ranging from 0-100; 0 corresponds to no symptoms and 100 to severe symptoms.	12 Weeks
Secondary	Change from baseline in lissamine green conjunctival staining (LGCS)	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.	12 Weeks
Secondary	Change from baseline in bulbar conjunctival hyperemia (CCLRU)	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.	12 Weeks