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

Sponsor

ReGenTree, LLC (Industry)

Overall Status

Completed

CT.gov ID

NCT02597803

Collaborator

(none)

317

Enrollment

Location

Arms

Duration (Months)

31.7

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 Solutions to placebo for the treatment of the signs and symptoms of dry eye.

Condition or Disease	Intervention/Treatment	Phase
Dry Eye Syndrome	Drug: RGN-259 Drug: Placebo	Phase 2/Phase 3

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

317 participants

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

Study Start Date :

Sep 1, 2015

Actual Primary Completion Date :

Jun 1, 2016

Actual Study Completion Date :

Jul 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
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 Names: 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

Arm

Intervention/Treatment

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 Names:

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

Outcome Measures

Primary Outcome Measures

Total corneal fluorescein staining score at day29 [29 days after first dosing]
Total ocular discomfort score at day29 [29 days after first dosing]

Secondary Outcome Measures

Tear film break-up time at day 8, 15, 29 [8, 15, 29 days after first dosing]
Unanesthetized Schirmer's Test at day 8, 15, 29 [8, 15, 29 days after first dosing]
Ocular Surface Disease Index (OSDI)© at day 8, 15, 29 [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 [1, 8, 15, 29 days after first dosing]
Change in biomicroscopy using slit-lamp at 8, 15, 29 days after first dosing [1, 8, 15, 29 days after first dosing]
Corneal Sensitivity (aesthesiometer (Cochet-Bonnet at 1, 8, 15, 29 days after first dosing [1, 8, 15, 29 days after first dosing]
Adverse event query at Visits 1,2,3, 4 and 5 [1, 8, 15, 29 days after first dosing]
Change in biomicroscopy using Undilated Fundoscopy at 1, 29 days after first dosing [1, 29 days after first dosing]
Intraocular Pressure at Visits 1, 29 days after first dosing [1, 29 days after first dosing]

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
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;