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

Tracking Information

• First Submitted Date: November 23, 2016
• First Posted Date: November 29, 2016
• Results First Submitted Date: November 5, 2021
• Results First Posted Date: January 5, 2022
• Last Update Posted Date: January 5, 2022
• Actual Study Start Date: November 2016
• Actual Primary Completion Date: September 2017 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: December 9, 2021)

• 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)
• 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)

Original Primary Outcome Measures (submitted: November 23, 2016)

• Ocular discomfort [ Time Frame: 29 days after first dosing ]
  Change from Baseline to day 29
• Corneal Fluorescein staining [ Time Frame: 29 days after first dosing ]
  Change from Baseline to day 29

Current Secondary Outcome Measures (submitted: December 9, 2021)

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

Original Secondary Outcome Measures (submitted: November 23, 2016)

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

Current Other Pre-specified Outcome Measures (submitted: December 9, 2021)

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

Original Other Pre-specified Outcome Measures (submitted: November 23, 2016)

• Visual acuity [ Time Frame: 1, 8, 15, 29 days ]
  Change or shifts from Baseline
• Change in biomicroscopy using the slit-lamp [ Time Frame: 1, 8, 15, 29 days ]
  Change or shifts from Baseline
• Adverse event query [ Time Frame: 1, 8, 15, 29 days ]
  Frequencies
• Change in biomicroscopy using the Undilated Fundoscopy [ Time Frame: 1, 29 days ]
  Change or shifts from Baseline

Descriptive Information

• Brief Title: Assessment of the Safety and Efficacy of RGN-259 Ophthalmic Solutions for Dry Eye Syndrome : ARISE-2
• 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
• 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 Type: Interventional
• Study Phase: Phase 3
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment
• Condition: Dry Eye Syndrome

Intervention

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

Study Arms

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

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: April 13, 2018): 601
• Original Estimated Enrollment (submitted: November 23, 2016): 500
• Actual Study Completion Date: March 2018
• Actual Primary Completion Date: September 2017 (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 ab uncontrolled systemic disease:

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: NCT02974907
• Other Study ID Numbers: RGN-259/16-110-0008
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided

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

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

• PRS Account: ReGenTree, LLC
• Verification Date: November 2021