Assessment of the Safety and Efficacy of RGN-259 Ophthalmic Solutions for Dry Eye Syndrome: ARISE-3
Registered Phase 3 interventional trial (completed). 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.
Registered clinical trial record on ClinicalTrials.gov (NCT03937882). This describes a planned, ongoing, or completed study — it is NOT peer-reviewed results. Status: completed. Study type: interventional. Phase: Phase 3. Sponsor: ReGenTree, LLC. Conditions: Dry Eye Syndromes, Dry Eye. Interventions: RGN-259, Placebo. 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. Primary outcome measures: Corneal staining; Ocular Discomfort 6-point (0=none, 5=worst) scale. 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
This is a registered clinical-trial record from ClinicalTrials.gov — a description of a planned, ongoing, or completed study, not peer-reviewed results. Listing on ClinicalTrials.gov does not mean the study has been evaluated by the U.S. Federal Government, nor does it imply endorsement or that the intervention is safe or effective.
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