Clinical Trial: Assessment of the Safety and Efficacy of RGN-259 Ophthalmic Solutions for Dry Eye Syndrome: ARISE-1
Study Status: Completed
Recruit Status: Completed
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:
- Total corneal fluorescein staining score at day29 [ Time Frame: 29 days after first dosing ]
- Total ocular discomfort score at day29 [ Time Frame: 29 days after first dosing ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Tear film break-up time at day 8, 15, 29 [ Time Frame: 8, 15, 29 days after first dosing ]
- Unanesthetized Schirmer's Test at day 8, 15, 29 [ Time Frame: 8, 15, 29 days after first dosing ]
- Ocular Surface Disease Index (OSDI)© at day 8, 15, 29 [ Time Frame: 8, 15, 29 days after first dosing ]
Original Secondary Outcome: Same as current
Information By: ReGenTree, LLC
Dates:
Date Received: October 26, 2015
Date Started: September 2015
Date Completion:
Last Updated: November 23, 2016
Last Verified: November 2016
