Clinical trial NCT05238597: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Dry Eye Disease
Lead sponsor: Aramis Biosciences, Inc.
Sponsor class: INDUSTRY
First posted: 2022-02-14
Enrollment: 207
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Change from baseline in total corneal fluorescein staining (CFS)
timeFrame: 12 Weeks
Secondary outcomes:
measure: Change from baseline in eye dryness via the Visual Analogue Scale (VAS)
timeFrame: 12 Weeks
measure: Change from baseline in lissamine green conjunctival staining (LGCS)
timeFrame: 12 Weeks
measure: Change from baseline in bulbar conjunctival hyperemia (CCLRU)
timeFrame: 12 Weeks
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Aramis Site 113
state: Alabama
city: Garden Grove
country: United States
facility: Aramis Site 121
state: California
city: Glendale
country: United States
facility: Aramis Site 120
state: California
city: Long Beach
country: United States
facility: Aramis Site 106
state: California
city: Los Angeles
country: United States
facility: Aramis Site 124
state: California
city: Murrieta
country: United States
facility: Aramis Site 107
state: California
city: Newport Beach
country: United States
facility: Aramis Site 102
state: California
city: Petaluma
country: United States
facility: Aramis Site 116
state: California
city: Rancho Cordova
country: United States
facility: Aramis Site 109
state: California
city: Delray Beach
country: United States
facility: Aramis Site 101
state: Florida
city: Jacksonville
country: United States
facility: Aramis Site 112
state: Florida
city: Largo
country: United States
facility: Aramis Site 117
state: Florida
city: Edgewood
country: United States
facility: Aramis Site 118
state: Kentucky
city: Kansas City
country: United States
facility: Aramis Site 114
state: Missouri
city: Saint Louis
country: United States
facility: Aramis Site 111
state: Missouri
city: Las Vegas
country: United States
facility: Aramis Site 108
state: Nevada
city: Garner
country: United States
facility: Aramis Site 110
state: North Carolina
city: Shelby
country: United States
facility: Aramis Site 122
state: North Carolina
city: Mason
country: United States
facility: Aramis Site 119
state: Ohio
city: Cranberry Township
country: United States
facility: Aramis Site 123
state: Pennsylvania
city: Goodlettsville
country: United States
facility: Aramis Site 115
state: Tennessee
city: Memphis
country: United States
facility: Aramis Site 103
state: Tennessee
city: Lakeway
country: United States
facility: Aramis Site 104
state: Texas
city: San Antonio
country: United States
facility: Aramis Site 105
state: Texas
Study officials:
affiliation: Aramis Biosciences
name: David S Tierney, MD
role: STUDY_DIRECTOR
References: