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

Primary Purpose

Dry Eye Disease

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
A197 Ophthalmic Solution
A197 Vehicle Control
Active Comparator
Sponsored by
Aramis Biosciences, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dry Eye Disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Aramis Site 113
  • Aramis Site 121
  • Aramis Site 120
  • Aramis Site 106
  • Aramis Site 124
  • Aramis Site 107
  • Aramis Site 102
  • Aramis Site 116
  • Aramis Site 109
  • Aramis Site 101
  • Aramis Site 112
  • Aramis Site 117
  • Aramis Site 118
  • Aramis Site 114
  • Aramis Site 111
  • Aramis Site 108
  • Aramis Site 110
  • Aramis Site 122
  • Aramis Site 119
  • Aramis Site 123
  • Aramis Site 115
  • Aramis Site 103
  • Aramis Site 104
  • Aramis Site 105

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Placebo Comparator

Active Comparator

Arm Label

A197 Ophthalmic Solution, High Dose

A197 Ophthalmic Solution, Low Dose

A197 Vehicle Control

Active Comparator

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.

Full Information

First Posted
February 3, 2022
Last Updated
May 15, 2023
Sponsor
Aramis Biosciences, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT05238597
Brief Title
A Study to Evaluate the Safety, Tolerability, and Efficacy of A197 in Subjects With Dry Eye Disease
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
January 25, 2022 (Actual)
Primary Completion Date
January 24, 2023 (Actual)
Study Completion Date
January 24, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Aramis Biosciences, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dry Eye Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
207 (Actual)

8. Arms, Groups, and Interventions

Arm Title
A197 Ophthalmic Solution, High Dose
Arm Type
Experimental
Arm Title
A197 Ophthalmic Solution, Low Dose
Arm Type
Experimental
Arm Title
A197 Vehicle Control
Arm Type
Placebo Comparator
Arm Title
Active Comparator
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
A197 Ophthalmic Solution
Intervention Description
A197 Ophthalmic Solution
Intervention Type
Drug
Intervention Name(s)
A197 Vehicle Control
Intervention Description
A197 Vehicle Control
Intervention Type
Drug
Intervention Name(s)
Active Comparator
Intervention Description
Active Comparator
Primary Outcome Measure Information:
Title
Change from baseline in total corneal fluorescein staining (CFS)
Description
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.
Time Frame
12 Weeks
Secondary Outcome Measure Information:
Title
Change from baseline in eye dryness via the Visual Analogue Scale (VAS)
Description
Eye dryness is rated on a visual analogue scale (VAS) ranging from 0-100; 0 corresponds to no symptoms and 100 to severe symptoms.
Time Frame
12 Weeks
Title
Change from baseline in lissamine green conjunctival staining (LGCS)
Description
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.
Time Frame
12 Weeks
Title
Change from baseline in bulbar conjunctival hyperemia (CCLRU)
Description
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.
Time Frame
12 Weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David S Tierney, MD
Organizational Affiliation
Aramis Biosciences
Official's Role
Study Director
Facility Information:
Facility Name
Aramis Site 113
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35233
Country
United States
Facility Name
Aramis Site 121
City
Garden Grove
State/Province
California
ZIP/Postal Code
92843
Country
United States
Facility Name
Aramis Site 120
City
Glendale
State/Province
California
ZIP/Postal Code
95817
Country
United States
Facility Name
Aramis Site 106
City
Long Beach
State/Province
California
ZIP/Postal Code
90805
Country
United States
Facility Name
Aramis Site 124
City
Los Angeles
State/Province
California
ZIP/Postal Code
90013
Country
United States
Facility Name
Aramis Site 107
City
Murrieta
State/Province
California
ZIP/Postal Code
92562
Country
United States
Facility Name
Aramis Site 102
City
Newport Beach
State/Province
California
ZIP/Postal Code
92663
Country
United States
Facility Name
Aramis Site 116
City
Petaluma
State/Province
California
ZIP/Postal Code
94954
Country
United States
Facility Name
Aramis Site 109
City
Rancho Cordova
State/Province
California
ZIP/Postal Code
95670
Country
United States
Facility Name
Aramis Site 101
City
Delray Beach
State/Province
Florida
ZIP/Postal Code
33484
Country
United States
Facility Name
Aramis Site 112
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32204
Country
United States
Facility Name
Aramis Site 117
City
Largo
State/Province
Florida
ZIP/Postal Code
33773
Country
United States
Facility Name
Aramis Site 118
City
Edgewood
State/Province
Kentucky
ZIP/Postal Code
41017
Country
United States
Facility Name
Aramis Site 114
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64111
Country
United States
Facility Name
Aramis Site 111
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63128
Country
United States
Facility Name
Aramis Site 108
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89119
Country
United States
Facility Name
Aramis Site 110
City
Garner
State/Province
North Carolina
ZIP/Postal Code
27529
Country
United States
Facility Name
Aramis Site 122
City
Shelby
State/Province
North Carolina
ZIP/Postal Code
28150
Country
United States
Facility Name
Aramis Site 119
City
Mason
State/Province
Ohio
ZIP/Postal Code
45040
Country
United States
Facility Name
Aramis Site 123
City
Cranberry Township
State/Province
Pennsylvania
ZIP/Postal Code
16066
Country
United States
Facility Name
Aramis Site 115
City
Goodlettsville
State/Province
Tennessee
ZIP/Postal Code
37072
Country
United States
Facility Name
Aramis Site 103
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38119
Country
United States
Facility Name
Aramis Site 104
City
Lakeway
State/Province
Texas
ZIP/Postal Code
78738
Country
United States
Facility Name
Aramis Site 105
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78215
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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

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