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

Purpose

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.

Condition	Intervention	Phase
Dry Eye Syndrome	Drug: RGN-259 Drug: Placebo	Phase 2 Phase 3


Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) Primary Purpose: Treatment
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

Further study details as provided by ReGenTree, LLC:

Primary Outcome Measures:

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 ]

Secondary Outcome Measures:

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 ]

Other Outcome Measures:

Visual acuity ( ETDRS, Early Treatment Diabetic Retinopathy Study scale) at 1, 8, 15, 29 days after first dosing [ Time Frame: 1, 8, 15, 29 days after first dosing ]
Change in biomicroscopy using slit-lamp at 8, 15, 29 days after first dosing [ Time Frame: 1, 8, 15, 29 days after first dosing ]
Corneal Sensitivity (aesthesiometer (Cochet-Bonnet at 1, 8, 15, 29 days after first dosing [ Time Frame: 1, 8, 15, 29 days after first dosing ]
Adverse event query at Visits 1,2,3, 4 and 5 [ Time Frame: 1, 8, 15, 29 days after first dosing ]
Change in biomicroscopy using Undilated Fundoscopy at 1, 29 days after first dosing [ Time Frame: 1, 29 days after first dosing ]
Intraocular Pressure at Visits 1, 29 days after first dosing [ Time Frame: 1, 29 days after first dosing ]


Enrollment:	317
Study Start Date:	September 2015
Study Completion Date:	July 2016
Primary Completion Date:	June 2016 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: High Dose RGN-259 High dose RGN-259: It is a preservative-free, sterile eye drop solution containing Tβ4	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
Placebo Comparator: Placebo It is composed of the same excipients as RGN-259 but does not contain Tβ4	Drug: Placebo It is composed of the same excipients as RGN-259 but does not contain Tβ4 Other Name: Vehicle Control
Experimental: Low Dose RGN-259 Low dose RGN-259: It is a preservative-free, sterile eye drop solution containing Tβ4	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

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.

Eligibility


Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

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
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;

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02597803

Locations


United States, Massachusetts
Andover, MA
Andover, Massachusetts, United States, 01810

Sponsors and Collaborators

ReGenTree, LLC

Investigators


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

More Information


Responsible Party:	ReGenTree, LLC
ClinicalTrials.gov Identifier:	NCT02597803 History of Changes
Other Study ID Numbers:	RGN-259
Study First Received:	October 26, 2015
Last Updated:	November 23, 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:	No

Keywords provided by ReGenTree, LLC:


Dry Eye Syndrome Dry Eye DES

Additional relevant MeSH terms:


Syndrome Keratoconjunctivitis Sicca Dry Eye Syndromes Disease Pathologic Processes Keratoconjunctivitis Conjunctivitis	Conjunctival Diseases Eye Diseases Keratitis Corneal Diseases Lacrimal Apparatus Diseases Pharmaceutical Solutions Ophthalmic Solutions

ClinicalTrials.gov processed this record on September 19, 2017