Assessment of the Safety and Efficacy of RGN-259 Ophthalmic Solutions for Dry Eye Syndrome: ARISE-1

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-1

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02597803
• Other study ID #: RGN-259
• Status: Completed
• Phase: Phase 2/Phase 3
• Start date: September 2015
• Est. completion date: July 2016

Study information

• Verified date: October 2019
• 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: 317
• Est. completion date: July 2016
• Est. primary completion date: June 2016
• 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

• Have a Schirmer's Test score of =10mm and =1mm

• Have a Tear Film Break-Up Time (TFBUT) =10 seconds

• Have a corneal fluorescein staining score of =2 in at least one region of the cornea

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 worn contact lenses within 7 days of Visit 1 or anticipate using contact lenses during the study;

• Have previously had laser-assisted in situ keratomileusis (LASIK) surgery within the last 6 months;

• Have an IOP > 25 mmHg at Visit 1;

• Have any planned ocular and/or lid surgeries over the study period;

• Be using or anticipate using temporary punctal plugs during the study that have not been stable within 30 days of Visit 1;

• Be currently taking any topical ophthalmic prescription (including medications for glaucoma) or over-the-counter (OTC) solutions, artificial tears, gels or scrubs, and cannot discontinue these medications for the duration of the trial (excluding medications allowed for the conduct of the study);

• Have corrected visual acuity greater than or equal to logMAR +0.7 as assessed by Early Treatment of Diabetic Retinopathy Study (ETDRS) scale in both eyes at Visit 1;

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 ( ETDRS, Early Treatment Diabetic Retinopathy Study scale) at 1, 8, 15, 29 days after first dosing		1, 8, 15, 29 days after first dosing
Other	Change in biomicroscopy using slit-lamp at 8, 15, 29 days after first dosing		1, 8, 15, 29 days after first dosing
Other	Corneal Sensitivity (aesthesiometer (Cochet-Bonnet at 1, 8, 15, 29 days after first dosing		1, 8, 15, 29 days after first dosing
Other	Adverse event query at Visits 1,2,3, 4 and 5		1, 8, 15, 29 days after first dosing
Other	Change in biomicroscopy using Undilated Fundoscopy at 1, 29 days after first dosing		1, 29 days after first dosing
Other	Intraocular Pressure at Visits 1, 29 days after first dosing		1, 29 days after first dosing
Primary	Total corneal fluorescein staining score at day29		29 days after first dosing
Primary	Total ocular discomfort score at day29		29 days after first dosing
Secondary	Tear film break-up time at day 8, 15, 29		8, 15, 29 days after first dosing
Secondary	Unanesthetized Schirmer's Test at day 8, 15, 29		8, 15, 29 days after first dosing
Secondary	Ocular Surface Disease Index (OSDI)© at day 8, 15, 29		8, 15, 29 days after first dosing