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

Dry Eye Syndrome Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02974907
• Other study ID #: RGN-259/16-110-0008
• Status: Completed
• Phase: Phase 3
• Start date: November 2016
• Est. completion date: March 2018

Study information

• Verified date: November 2021
• Source: ReGenTree, LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 601
• Est. completion date: March 2018
• Est. primary completion date: September 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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:

Related Conditions & MeSH terms

• Dry Eye Syndrome
• Dry Eye Syndromes
• Keratoconjunctivitis Sicca
• Syndrome

Intervention

Drug:
• RGN-259
A preservative-free, sterile eye drop solution containing Tß4 for direct instillation into each eye, four times a day (QID) for 28 days
• Placebo
It is composed of the same excipients as RGN-259 but does not contain Tß4

Locations

Country	Name	City	State
United States	Andover, MA	Andover	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
ReGenTree, LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Visual Acuity	Change or shifts from Baseline	1, 8, 15, 29 days
Other	Change in Biomicroscopy Using the Slit-lamp	Change or shifts from Baseline	1, 8, 15, 29 days
Other	Adverse Event Query	Frequencies	1, 8, 15, 29 days
Other	Change in Biomicroscopy Using the Undilated Fundoscopy	Change or shifts from Baseline	1, 29 days
Primary	Ocular Discomfort	Change from Baseline at Day 29 using the Ora Calibra® Ocular Discomfort Scale (6-point scale where 0 = none and 5 = worst)	29 days after first dosing
Primary	Corneal Fluorescein Staining	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)	29 days after first dosing
Secondary	Corneal Fluorescein Staining	Comparing each of active group & Placebo.	8, 15, 29 days after first dosing
Secondary	Unanesthetized Schirmer's Test	Comparing each of active group & Placebo.	29 days after first dosing
Secondary	Ocular Surface Disease Index (OSDI)©	Comparing each of active group & Placebo.	8, 15, 29 days after first dosing
Secondary	Tear Film Break-Up Time	Comparing each of active group & Placebo.	8, 15, 29 days after first dosing