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

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

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

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 Summary: 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.
Sponsor: ReGenTree, LLC

Current Primary Outcome:

• 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

Original Primary Outcome: Same as current

Current Secondary Outcome:

• 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: Same as current

Information By: ReGenTree, LLC

Dates:
Date Received: November 23, 2016
Date Started: November 2016
Date Completion: November 2017
Last Updated: November 23, 2016
Last Verified: November 2016