Assessment of the Safety and Efficacy of RGN-259 Ophthalmic Solutions for Dry Eye Syndrome : ARISE-2

ReGenTree, LLC601 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

601

Conditions

Dry Eye Syndrome

Interventions

RGN-259DRUG

A preservative-free, sterile eye drop solution containing Tβ4 for direct instillation into each eye, four times a day (QID) for 28 days

PlaceboDRUG

It is composed of the same excipients as RGN-259 but does not contain Tβ4

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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:

Locations (1)

Andover, MA

Andover, Massachusetts, United States

Outcomes

Primary Outcomes

Ocular Discomfort

Change from Baseline at Day 29 using the Ora Calibra® Ocular Discomfort Scale (6-point scale where 0 = none and 5 = worst)

Time frame: 29 days after first dosing

Corneal Fluorescein Staining

Change from Baseline at Day 29 using the Ora Calibra® scale (5-point scale with half (0.5) increments where 0 = none and 4 = severe)

Time frame: 29 days after first dosing

Secondary Outcomes

Corneal Fluorescein Staining

Comparing each of active group \& Placebo.

Time frame: 8, 15, 29 days after first dosing

Unanesthetized Schirmer's Test

Comparing each of active group \& Placebo.

Time frame: 29 days after first dosing

Comparing each of active group \& Placebo.

Time frame: 8, 15, 29 days after first dosing

Tear Film Break-Up Time

Comparing each of active group \& Placebo.

Time frame: 8, 15, 29 days after first dosing

Data from ClinicalTrials.gov

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