Clinical trial NCT03937882: Assessment of the Safety and Efficacy of RGN-259 Ophthalmic Solutions for Dry Eye Syndrome: ARISE-3
Official title: A Multi-Center, Randomized, Double Masked, Placebo Controlled Clinical Study to Assess the Safety and Efficacy of RGN-259 Ophthalmic Solutions for the Treatment of Dry Eye (ARISE-3)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Dry Eye Syndromes
Dry Eye
Keywords: Dry Eye
Dry Eye Syndrome
DES
Lead sponsor: ReGenTree, LLC
Sponsor class: INDUSTRY
First posted: 2019-05-06
Enrollment: 700
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Subjects will be randomized in a 1:1 ratio RGN-259 to placebo ophthalmic solution.
Primary purpose: TREATMENT

Brief summary: The objective of this study is to compare the safety and efficacy of RGN-259 Ophthalmic Solution to placebo for the treatment of the signs and symptoms of dry eye.


Eligibility criteria: Inclusion Criteria:

* Be at least 18 years of age;
* Provide written informed consent;
* Have a subject reported history of dry eye for at least 6 months;
* Have a history of use or desire to use eye drops for dry eye symptoms within 6 months

Exclusion Criteria:

* Have any clinically significant slit-lamp findings at Visit 1 that may include active blepharitis, meibomian gland dysfunction (MGD), lid margin inflammation or active ocular allergies that require therapeutic treatment, and/or in the opinion of the investigator may interfere with study parameters;
* Be diagnosed with an ongoing ocular infection (bacterial, viral, or fungal), or active ocular inflammation at Visit 1;
* Have an uncontrolled systemic disease;
* Be a woman who is pregnant, nursing or planning a pregnancy

Primary outcomes:
measure: Corneal staining
timeFrame: 15 days after first dosing
measure: Ocular Discomfort 6-point (0=none, 5=worst) scale
timeFrame: 15 days after first dosing
Secondary outcomes:
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Cornea and Cataract Consultants of Arizona
state: Arizona
city: Newport Beach
country: United States
facility: Eye Research Foundation
state: California
city: Colorado Springs
country: United States
facility: Vision Institute
state: Colorado
city: Chicago
country: United States
facility: Dovilan Wyatt MD, LLC
state: Illinois
city: Indianapolis
country: United States
facility: Whitson Vision
state: Indiana
city: Indianapolis
country: United States
facility: Midwest Cornea Associates, LLC
state: Indiana
city: Louisville
country: United States
facility: The Eye Care Institute
state: Kentucky
city: Andover
country: United States
facility: Andover Eye Associates
state: Massachusetts
city: Raynham
country: United States
facility: Andover Eye Associates
state: Massachusetts
city: Henderson
country: United States
facility: Center For Sight
state: Nevada
city: Raleigh
country: United States
facility: Oculus Research, Inc. at the Eye Care Center
state: North Carolina
city: Shelby
country: United States
facility: Visual Eyes Optometric
state: North Carolina
city: Fargo
country: United States
facility: Bergstrom Eye Research, LLC
state: North Dakota
city: Cranberry Township
country: United States
facility: Scott & Christie and Associates, PC
state: Pennsylvania
city: Warwick
country: United States
facility: Andover Eye Associates
state: Rhode Island
city: Memphis
country: United States
facility: Total Eye Care, P.A.
state: Tennessee
city: Austin
country: United States
facility: Texan Eye/Keystone Research
state: Texas
city: Layton
country: United States
facility: Mountain View Eye Center
state: Utah
city: Ogden
country: United States
facility: Country Hills Eye Center
state: Utah
city: Lynchburg
country: United States
facility: Piedmont Eye Center
state: Virginia
Study officials:
References: