Assessment of the Safety and Efficacy of RGN-259 Ophthalmic Solutions for Dry Eye Syndrome: ARISE-3
- Registration Number
- NCT03937882
- Lead Sponsor
- ReGenTree, LLC
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 700
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo It is composed of the same excipients as RGN-259 but does not contain Thymosin beta 4 RGN-259 RGN-259 RGN-259: It is a preservative-free, sterile eye drop solution containing Thymosin beta 4
- Primary Outcome Measures
Name Time Method Ocular Discomfort 6-point (0=none, 5=worst) scale 15 days after first dosing Mean change from baseline to Day 15 of Ocular Discomfort severity
Corneal staining 15 days after first dosing Mean change from baseline to Day 15 of Inferior Corneal Fluorescein Staining
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (18)
Cornea and Cataract Consultants of Arizona
🇺🇸Phoenix, Arizona, United States
Eye Research Foundation
🇺🇸Newport Beach, California, United States
Vision Institute
🇺🇸Colorado Springs, Colorado, United States
Dovilan Wyatt MD, LLC
🇺🇸Chicago, Illinois, United States
Whitson Vision
🇺🇸Indianapolis, Indiana, United States
Midwest Cornea Associates, LLC
🇺🇸Indianapolis, Indiana, United States
The Eye Care Institute
🇺🇸Louisville, Kentucky, United States
Andover Eye Associates
🇺🇸Warwick, Rhode Island, United States
Center For Sight
🇺🇸Henderson, Nevada, United States
Oculus Research, Inc. at the Eye Care Center
🇺🇸Raleigh, North Carolina, United States
Scroll for more (8 remaining)Cornea and Cataract Consultants of Arizona🇺🇸Phoenix, Arizona, United States