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

Study Overview
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Brief Summary
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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.

Official Title
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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)

Conditions
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Dry Eye Syndromes, Dry Eye

Intervention / Treatment
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* Drug: RGN-259
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Subjects will be randomized in a 1:1 ratio RGN-259 to placebo ophthalmic solution.
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: RGN-259<br>RGN-259: It is a preservative-free, sterile eye drop solution containing Thymosin beta 4 | Drug: RGN-259<br>* 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<br>* Other names: Thymosin Beta 4;|
| Placebo Comparator: Placebo<br>It is composed of the same excipients as RGN-259 but does not contain Thymosin beta 4 | Drug: Placebo<br>* It is composed of the same excipients as RGN-259 but does not contain Thymosin beta 4<br>* Other names: Vehicle Control;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Corneal staining | Mean change from baseline to Day 15 of Inferior Corneal Fluorescein Staining | 15 days after first dosing | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Dry Eye, Dry Eye Syndrome, DES