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

• ClinicalTrials.gov Identifier: NCT02974907
• Recruitment Status: Completed
• First Posted: November 29, 2016
• Results First Posted: January 5, 2022
• Last Update Posted: January 5, 2022
• Sponsor: ReGenTree, LLC
• Information provided by (Responsible Party): ReGenTree, LLC

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Dry Eye Syndrome	Drug: RGN-259; Drug: Placebo	Phase 3

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 601 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: 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
• Actual Study Start Date: November 2016
• Actual Primary Completion Date: September 2017
• Actual Study Completion Date: March 2018

Arms and Interventions

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 Name: Vehicle Control

Outcome Measures

Primary Outcome Measures :

1. Ocular Discomfort [ Time Frame: 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)
2. Corneal Fluorescein Staining [ Time Frame: 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)

Secondary Outcome Measures :

1. Corneal Fluorescein Staining [ Time Frame: 8, 15, 29 days after first dosing ]
   Comparing each of active group & Placebo.
2. Unanesthetized Schirmer's Test [ Time Frame: 29 days after first dosing ]
   Comparing each of active group & Placebo.
3. Ocular Surface Disease Index (OSDI)© [ Time Frame: 8, 15, 29 days after first dosing ]
   Comparing each of active group & Placebo.
4. Tear Film Break-Up Time [ Time Frame: 8, 15, 29 days after first dosing ]
   Comparing each of active group & Placebo.

Other Outcome Measures:

1. Visual Acuity [ Time Frame: 1, 8, 15, 29 days ]
   Change or shifts from Baseline
2. Change in Biomicroscopy Using the Slit-lamp [ Time Frame: 1, 8, 15, 29 days ]
   Change or shifts from Baseline
3. Adverse Event Query [ Time Frame: 1, 8, 15, 29 days ]
   Frequencies
4. Change in Biomicroscopy Using the Undilated Fundoscopy [ Time Frame: 1, 29 days ]
   Change or shifts from Baseline

Eligibility Criteria

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

Criteria

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:

Contacts and Locations

Locations

United States, Massachusetts

Andover, MA

Andover, Massachusetts, United States, 01810

Sponsors and Collaborators

ReGenTree, LLC

Investigators

• Principal Investigator: Gail Torkildsen, MD; Ora Clinical Research and Development

  Study Documents (Full-Text)

Documents provided by ReGenTree, LLC:

Study Protocol  [PDF] July 21, 2017

Statistical Analysis Plan  [PDF] August 8, 2017

More Information

• Responsible Party: ReGenTree, LLC
• ClinicalTrials.gov Identifier: NCT02974907
• Other Study ID Numbers: RGN-259/16-110-0008
• First Posted: November 29, 2016
• Results First Posted: January 5, 2022
• Last Update Posted: January 5, 2022
• Last Verified: November 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

Keywords provided by ReGenTree, LLC:

Dry Eye Syndrome; Dry Eye; DES

Additional relevant MeSH terms:

Dry Eye Syndromes; Keratoconjunctivitis Sicca; Syndrome; Disease; Pathologic Processes; Lacrimal Apparatus Diseases; Eye Diseases; Keratoconjunctivitis; Conjunctivitis; Conjunctival Diseases; Keratitis; Corneal Diseases