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

• ClinicalTrials.gov Identifier: NCT03937882
• Recruitment Status: Completed
• First Posted: May 6, 2019
• Last Update Posted: May 9, 2022
• Sponsor: ReGenTree, LLC
• Information provided by (Responsible Party): ReGenTree, LLC

Tracking Information

• First Submitted Date: May 1, 2019
• First Posted Date: May 6, 2019
• Last Update Posted Date: May 9, 2022
• Actual Study Start Date: May 24, 2019
• Actual Primary Completion Date: November 8, 2020 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: May 2, 2019)

• Corneal staining [ Time Frame: 15 days after first dosing ]
  Mean change from baseline to Day 15 of Inferior Corneal Fluorescein Staining
• Ocular Discomfort 6-point (0=none, 5=worst) scale [ Time Frame: 15 days after first dosing ]
  Mean change from baseline to Day 15 of Ocular Discomfort severity

• Original Primary Outcome Measures: Same as current
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Assessment of the Safety and Efficacy of RGN-259 Ophthalmic Solutions for Dry Eye Syndrome: ARISE-3
• 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-3)
• Brief Summary: 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.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 3

Study Design

Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

Subjects will be randomized in a 1:1 ratio RGN-259 to placebo ophthalmic solution.

Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description:

All subjects, investigators, and study personnel involved with the conduct of the study will be masked with regard to treatment assignments.

Primary Purpose: Treatment

Condition

• Dry Eye Syndromes
• Dry Eye

Intervention

• Drug: RGN-259
  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
  Other Names:

  • Tβ4
  • Thymosin Beta 4
• Drug: Placebo
  It is composed of the same excipients as RGN-259 but does not contain Thymosin beta 4
  Other Name: Vehicle Control

Study Arms

• Experimental: RGN-259
  RGN-259: It is a preservative-free, sterile eye drop solution containing Thymosin beta 4
  Intervention: Drug: RGN-259
• Placebo Comparator: Placebo
  It is composed of the same excipients as RGN-259 but does not contain Thymosin beta 4
  Intervention: Drug: Placebo

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: May 2, 2019): 700
• Original Estimated Enrollment: Same as current
• Actual Study Completion Date: October 7, 2021
• Actual Primary Completion Date: November 8, 2020 (Final data collection date for primary outcome measure)

Eligibility 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 an uncontrolled systemic disease;
• Be a woman who is pregnant, nursing or planning a pregnancy

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT03937882
• Other Study ID Numbers: RGN-259/19-110-0002
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: ReGenTree, LLC
• Original Responsible Party: Same as current
• Current Study Sponsor: ReGenTree, LLC
• Original Study Sponsor: Same as current
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: ReGenTree, LLC
• Verification Date: November 2021