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

NCT ID: NCT02597803

Last Updated: 2019-10-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 317 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-09-30
• Study Completion Date: 2016-07-31

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.

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.

Conditions

Dry Eye Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

High Dose RGN-259

High dose RGN-259: It is a preservative-free, sterile eye drop solution containing Tβ4

Group Type: EXPERIMENTAL

RGN-259

Intervention Type: DRUG

A preservative-free, sterile eye drop solution containing Tβ4 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 Tβ4

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

It is composed of the same excipients as RGN-259 but does not contain Tβ4

Low Dose RGN-259

Low dose RGN-259: It is a preservative-free, sterile eye drop solution containing Tβ4

Group Type: EXPERIMENTAL

RGN-259

Intervention Type: DRUG

A preservative-free, sterile eye drop solution containing Tβ4 for direct instillation into each eye, four times a day (QID) for 28 days

Interventions

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

Intervention Type: DRUG

Placebo

It is composed of the same excipients as RGN-259 but does not contain Tβ4

Intervention Type: DRUG

Other Intervention Names

Tβ4; Thymosin Beta 4; Vehicle Control

Eligibility 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;

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

ReGenTree, LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Gail Torkildsen, MD

Role: PRINCIPAL_INVESTIGATOR

Ora Clinical Research and Development

Locations

Andover, MA

Andover, Massachusetts, United States

Countries

United States

Other Identifiers

RGN-259

Identifier Type: -

Identifier Source: org_study_id