Assessment of the Safety and Efficacy of RGN-259 Ophthalmic Solutions for Dry Eye Syndrome : ARISE-2

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

601 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-11-30

Study Completion Date

2018-03-31

Brief Summary

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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.

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Detailed Description

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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

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Dry Eye Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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RGN-259

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

Interventions

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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

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Tβ4 Thymosin Beta 4 Vehicle Control

Eligibility Criteria

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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 ab uncontrolled systemic disease:

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No