Assessment of the Safety and Efficacy of RGN-259 Ophthalmic Solutions for Dry Eye Syndrome : ARISE-2
Registered Phase 3 interventional trial (completed), with sponsor-posted results. The objective of this study is to compare the safety and efficacy of RGN-259 Ophthalmic Solutions to placebo for the treatment of the signs and symptoms of dry eye.
Registered clinical trial record on ClinicalTrials.gov (NCT02974907). This describes a planned, ongoing, or completed study — it is NOT peer-reviewed results, though the sponsor has posted summary results. Status: completed. Study type: interventional. Phase: Phase 3. Sponsor: ReGenTree, LLC. Conditions: Dry Eye Syndrome. Interventions: RGN-259, Placebo. Summary: The objective of this study is to compare the safety and efficacy of RGN-259 Ophthalmic Solutions to placebo for the treatment of the signs and symptoms of dry eye. Dry eye can be caused by many variable factors. Some examples include hormonal changes due to aging, or living in an environment of low humidity for long periods of time. Dry eye is a complex disease that may result in symptoms like discomfort, visual disturbance, and dryness. Patients with dry eye often have damage on the surface of the eye. In previous studies, RGN-259 has been shown to promote healing of the surface of the eye and decrease inflammation. It suggests that RGN-259 has a significant potential to be an important new safe and effective therapeutic in the treatment of dry eye syndrome. Primary outcome measures: Ocular Discomfort; Corneal Fluorescein Staining. 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 ab uncontrolled systemic disease:
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a registered clinical-trial record from ClinicalTrials.gov — a description of a planned, ongoing, or completed study, not peer-reviewed results.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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