Assessment of the Safety and Efficacy of RGN-259 Ophthalmic Solutions for Dry Eye Syndrome: ARISE-3

Dry Eye Clinical Trial

— 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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03937882
• Other study ID #: RGN-259/19-110-0002
• Status: Completed
• Phase: Phase 3
• Start date: May 24, 2019
• Est. completion date: October 7, 2021

Study information

• Verified date: November 2021
• Source: ReGenTree, LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 700
• Est. completion date: October 7, 2021
• Est. primary completion date: November 8, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Dry Eye
• Dry Eye Syndromes
• Keratoconjunctivitis Sicca
• Syndrome

Intervention

Drug:
• RGN-259
A preservative-free, sterile eye drop solution containing Thymosin beta 4 for direct instillation into each eye, four times a day (QID) for 14 days
• Placebo
It is composed of the same excipients as RGN-259 but does not contain Thymosin beta 4

Locations

Country	Name	City	State
United States	Andover Eye Associates	Andover	Massachusetts
United States	Texan Eye/Keystone Research	Austin	Texas
United States	Dovilan Wyatt MD, LLC	Chicago	Illinois
United States	Vision Institute	Colorado Springs	Colorado
United States	Scott & Christie and Associates, PC	Cranberry Township	Pennsylvania
United States	Bergstrom Eye Research, LLC	Fargo	North Dakota
United States	Center For Sight	Henderson	Nevada
United States	Midwest Cornea Associates, LLC	Indianapolis	Indiana
United States	Whitson Vision	Indianapolis	Indiana
United States	Mountain View Eye Center	Layton	Utah
United States	The Eye Care Institute	Louisville	Kentucky
United States	Piedmont Eye Center	Lynchburg	Virginia
United States	Total Eye Care, P.A.	Memphis	Tennessee
United States	Eye Research Foundation	Newport Beach	California
United States	Country Hills Eye Center	Ogden	Utah
United States	Cornea and Cataract Consultants of Arizona	Phoenix	Arizona
United States	Oculus Research, Inc. at the Eye Care Center	Raleigh	North Carolina
United States	Andover Eye Associates	Raynham	Massachusetts
United States	Visual Eyes Optometric	Shelby	North Carolina
United States	Andover Eye Associates	Warwick	Rhode Island

Sponsors (1)

Lead Sponsor	Collaborator
ReGenTree, LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Corneal staining	Mean change from baseline to Day 15 of Inferior Corneal Fluorescein Staining	15 days after first dosing
Primary	Ocular Discomfort 6-point (0=none, 5=worst) scale	Mean change from baseline to Day 15 of Ocular Discomfort severity	15 days after first dosing