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)

ReGenTree, LLC18 sites in 1 country700 target enrollmentMay 24, 2019

ConditionsDry Eye Syndromes Dry Eye

InterventionsRGN-259 Placebo

DrugsRGN-259 Placebo

Overview

Phase: Phase 3
Intervention: RGN-259
Conditions: Dry Eye Syndromes
Sponsor: ReGenTree, LLC
Enrollment: 700
Locations: 18
Primary Endpoint: Corneal staining
Status: Completed
Last Updated: 3 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

May 24, 2019

End Date

October 7, 2021

Last Updated

3 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

ReGenTree, LLC

Responsible Party

Sponsor

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