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

Sponsor

Aramis Biosciences, Inc. (Industry)

Overall Status

Recruiting

CT.gov ID

NCT05238597

Collaborator

(none)

200

Enrollment

Locations

Arms

13.1

Anticipated Duration (Months)

8.7

Patients Per Site

0.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Dry Eye Disease	Drug: A197 Ophthalmic Solution Drug: A197 Vehicle Control Drug: Active Comparator	Phase 2

Study Design

Study Type:

Interventional

Anticipated Enrollment :

200 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

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

Actual Study Start Date :

Jan 25, 2022

Anticipated Primary Completion Date :

Mar 1, 2023

Anticipated Study Completion Date :

Mar 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: A197 Ophthalmic Solution, High Dose	Drug: A197 Ophthalmic Solution A197 Ophthalmic Solution
Experimental: A197 Ophthalmic Solution, Low Dose	Drug: A197 Ophthalmic Solution A197 Ophthalmic Solution
Placebo Comparator: A197 Vehicle Control	Drug: A197 Vehicle Control A197 Vehicle Control
Active Comparator: Active Comparator	Drug: Active Comparator Active Comparator

Outcome Measures

Primary Outcome Measures

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

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Aramis Site 113	Birmingham	Alabama	United States	35233
2	Aramis Site 121	Garden Grove	California	United States	92843
3	Aramis Site 120	Glendale	California	United States	95817
4	Aramis Site 106	Long Beach	California	United States	90805
5	Aramis Site 107	Murrieta	California	United States	92562
6	Aramis Site 102	Newport Beach	California	United States	92663
7	Aramis Site 116	Petaluma	California	United States	94954
8	Aramis Site 109	Rancho Cordova	California	United States	95670
9	Aramis Site 101	Delray Beach	Florida	United States	33484
10	Aramis Site 112	Jacksonville	Florida	United States	32204
11	Aramis Site 117	Largo	Florida	United States	33773
12	Aramis Site 118	Edgewood	Kentucky	United States	41017
13	Aramis Site 114	Kansas City	Missouri	United States	64111
14	Aramis Site 111	Saint Louis	Missouri	United States	63128
15	Aramis Site 108	Las Vegas	Nevada	United States	89119
16	Aramis Site 110	Garner	North Carolina	United States	27529
17	Aramis Site 122	Shelby	North Carolina	United States	28150
18	Aramis Site 119	Mason	Ohio	United States	45040
19	Aramis Site 123	Cranberry Township	Pennsylvania	United States	16066
20	Aramis Site 115	Goodlettsville	Tennessee	United States	37072
21	Aramis Site 103	Memphis	Tennessee	United States	38119
22	Aramis Site 104	Lakeway	Texas	United States	78738
23	Aramis Site 105	San Antonio	Texas	United States	78215

Sponsors and Collaborators

Aramis Biosciences, Inc.

Investigators

Study Director: David S Tierney, MD, Aramis Biosciences

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Aramis Biosciences, Inc.

ClinicalTrials.gov Identifier:

NCT05238597

Other Study ID Numbers:

A197-CS-201

First Posted:

Feb 14, 2022

Last Update Posted:

Aug 17, 2022

Last Verified:

Aug 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Dry Eye Syndromes

Keratoconjunctivitis Sicca

Eye Diseases

Ophthalmic Solutions

Study Results

No Results Posted as of Aug 17, 2022