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

Phase 3

Completed

• Conditions: Dry Eye Syndrome
• Interventions: Drug: RGN-259; Drug: Placebo

• Registration Number: NCT02974907
• Lead Sponsor: ReGenTree, LLC

Brief 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.

Detailed Description

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 Timeline

• Study Start: 2016-11
• Study First Submitted: 2016-11-23
• Study First Submitted QC: 2016-11-23
• Study First Posted: 2016-11-29
• Primary Completion: 2017-09
• Study Completion: 2018-03
• Disposition First Submitted: 2020-10-22
• Disposition First Submitted QC: 2020-10-22
• Disposition First Posted: 2020-10-28
• Status Verified: 2021-11
• Results First Submitted: 2021-11-05
• Results First Submitted QC: 2021-12-09
• Last Update Submitted: 2021-12-09
• Results First Posted: 2022-01-05
• Last Update Posted: 2022-01-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 601

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

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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:

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
RGN-259	RGN-259	RGN-259: It is a preservative-free, sterile eye drop solution containing Tβ4
Placebo	Placebo	It is composed of the same excipients as RGN-259 but does not contain Tβ4

Primary Outcome Measures

Name	Time	Method
Corneal Fluorescein Staining	29 days after first dosing	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)
Ocular Discomfort	29 days after first dosing	Change from Baseline at Day 29 using the Ora Calibra® Ocular Discomfort Scale (6-point scale where 0 = none and 5 = worst)

Secondary Outcome Measures

Name	Time	Method
Corneal Fluorescein Staining	8, 15, 29 days after first dosing	Comparing each of active group \& Placebo.
Unanesthetized Schirmer's Test	29 days after first dosing	Comparing each of active group \& Placebo.
Ocular Surface Disease Index (OSDI)©	8, 15, 29 days after first dosing	Comparing each of active group \& Placebo.
Tear Film Break-Up Time	8, 15, 29 days after first dosing	Comparing each of active group \& Placebo.

Trial Locations

Locations (1)

Andover, MA; 🇺🇸 Andover, Massachusetts, United States