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

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-2

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.

Study Overview

• Status: Completed
• Conditions: Dry Eye Syndrome
• Intervention / Treatment: Drug: RGN-259; Drug: Placebo

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 Type: Interventional
• Enrollment (Actual): 601
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Andover, Massachusetts, United States, 01810
      • Andover, MA

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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:

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: RGN-259; RGN-259: It is a preservative-free, sterile eye drop solution containing Tβ4	Drug: RGN-259; A preservative-free, sterile eye drop solution containing Tβ4 for direct instillation into each eye, four times a day (QID) for 28 days; Other Names: Tβ4; Thymosin Beta 4
Placebo Comparator: Placebo; It is composed of the same excipients as RGN-259 but does not contain Tβ4	Drug: Placebo; It is composed of the same excipients as RGN-259 but does not contain Tβ4; Other Names: Vehicle Control

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Ocular Discomfort	Change from Baseline at Day 29 using the Ora Calibra® Ocular Discomfort Scale (6-point scale where 0 = none and 5 = worst)	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)	29 days after first dosing

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Visual Acuity	Change or shifts from Baseline	1, 8, 15, 29 days
Change in Biomicroscopy Using the Slit-lamp	Change or shifts from Baseline	1, 8, 15, 29 days
Adverse Event Query	Frequencies	1, 8, 15, 29 days
Change in Biomicroscopy Using the Undilated Fundoscopy	Change or shifts from Baseline	1, 29 days

Collaborators and Investigators

• Sponsor: ReGenTree, LLC

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2016
• Primary Completion (Actual): September 1, 2017
• Study Completion (Actual): March 1, 2018

Study Registration Dates

• First Submitted: November 23, 2016
• First Submitted That Met QC Criteria: November 23, 2016
• First Posted (Estimate): November 29, 2016

Study Record Updates

• Last Update Posted (Actual): January 5, 2022
• Last Update Submitted That Met QC Criteria: December 9, 2021
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Keywords: Dry Eye; Dry Eye Syndrome; DES
• Additional Relevant MeSH Terms: Pathologic Processes; Eye Diseases; Disease; Lacrimal Apparatus Diseases; Keratoconjunctivitis; Conjunctivitis; Conjunctival Diseases; Keratitis; Corneal Diseases; Syndrome; Dry Eye Syndromes; Keratoconjunctivitis Sicca
• Other Study ID Numbers: RGN-259/16-110-0008

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No