Assessment of the Safety and Efficacy of RGN-259 Ophthalmic Solutions for Dry Eye Syndrome: ARISE-3

Sponsor

ReGenTree, LLC (Industry)

Overall Status

Completed

CT.gov ID

NCT03937882

Collaborator

(none)

700

Enrollment

Locations

Arms

28.5

Actual Duration (Months)

Patients Per Site

1.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The objective of this study is to compare the safety and efficacy of RGN-259 Ophthalmic Solution to placebo for the treatment of the signs and symptoms of dry eye.

Condition or Disease	Intervention/Treatment	Phase
Dry Eye Syndromes Dry Eye	Drug: RGN-259 Drug: Placebo	Phase 3

Study Design

Study Type:

Interventional

Actual Enrollment :

700 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Subjects will be randomized in a 1:1 ratio RGN-259 to placebo ophthalmic solution.Subjects will be randomized in a 1:1 ratio RGN-259 to placebo ophthalmic solution.

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Masking Description:

All subjects, investigators, and study personnel involved with the conduct of the study will be masked with regard to treatment assignments.

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-3)

Actual Study Start Date :

May 24, 2019

Actual Primary Completion Date :

Nov 8, 2020

Actual Study Completion Date :

Oct 7, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: RGN-259 RGN-259: It is a preservative-free, sterile eye drop solution containing Thymosin beta 4	Drug: RGN-259 A preservative-free, sterile eye drop solution containing Thymosin beta 4 for direct instillation into each eye, four times a day (QID) for 14 days Other Names: Tβ4 Thymosin Beta 4
Placebo Comparator: Placebo It is composed of the same excipients as RGN-259 but does not contain Thymosin beta 4	Drug: Placebo It is composed of the same excipients as RGN-259 but does not contain Thymosin beta 4 Other Names: Vehicle Control

Arm

Intervention/Treatment

Experimental: RGN-259

RGN-259: It is a preservative-free, sterile eye drop solution containing Thymosin beta 4

Drug: RGN-259

A preservative-free, sterile eye drop solution containing Thymosin beta 4 for direct instillation into each eye, four times a day (QID) for 14 days

Other Names:

Tβ4

Thymosin Beta 4

Placebo Comparator: Placebo

It is composed of the same excipients as RGN-259 but does not contain Thymosin beta 4

Drug: Placebo

It is composed of the same excipients as RGN-259 but does not contain Thymosin beta 4

Other Names:

Vehicle Control

Outcome Measures

Primary Outcome Measures

Corneal staining [15 days after first dosing]
Mean change from baseline to Day 15 of Inferior Corneal Fluorescein Staining
Ocular Discomfort 6-point (0=none, 5=worst) scale [15 days after first dosing]
Mean change from baseline to Day 15 of Ocular Discomfort severity

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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 an uncontrolled systemic disease;
Be a woman who is pregnant, nursing or planning a pregnancy

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Cornea and Cataract Consultants of Arizona	Phoenix	Arizona	United States	85032
2	Eye Research Foundation	Newport Beach	California	United States	92663
3	Vision Institute	Colorado Springs	Colorado	United States	80907
4	Dovilan Wyatt MD, LLC	Chicago	Illinois	United States	60619
5	Whitson Vision	Indianapolis	Indiana	United States	46240
6	Midwest Cornea Associates, LLC	Indianapolis	Indiana	United States	46290
7	The Eye Care Institute	Louisville	Kentucky	United States	40206
8	Andover Eye Associates	Andover	Massachusetts	United States	01810
9	Andover Eye Associates	Raynham	Massachusetts	United States	02767
10	Center For Sight	Henderson	Nevada	United States	89052
11	Oculus Research, Inc. at the Eye Care Center	Raleigh	North Carolina	United States	27603
12	Visual Eyes Optometric	Shelby	North Carolina	United States	28150
13	Bergstrom Eye Research, LLC	Fargo	North Dakota	United States	58103
14	Scott & Christie and Associates, PC	Cranberry Township	Pennsylvania	United States	16066
15	Andover Eye Associates	Warwick	Rhode Island	United States	02886
16	Total Eye Care, P.A.	Memphis	Tennessee	United States	38119
17	Texan Eye/Keystone Research	Austin	Texas	United States	78731
18	Mountain View Eye Center	Layton	Utah	United States	84041
19	Country Hills Eye Center	Ogden	Utah	United States	84403
20	Piedmont Eye Center	Lynchburg	Virginia	United States	24502