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

What Was Tested

The trial (phase 3) is built around Thymosin Beta-4 (full length).

It had two arms (groups): RGN-259 (experimental) and Placebo (placebo comparator).

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

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

The registry classes the interventions as drug.

More on the Plan

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.

Who Took Part

Enrollment: 601 actual participants took part.

It was open to people of any sex aged from 18 years with no upper age limit.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Be at least 18 years of age;. Provide written informed consent;. Have a subject reported history of dry eye prior to Visit 1;. Have a history of use or desire to use eye drops for dry eye symptoms;.

The full record lists 4 inclusion and 3 exclusion criteria; among the exclusions: be diagnosed with an ongoing ocular infection (bacterial, viral, or fungal), or active ocular inflammation at visit 1;; have an uncontrolled systemic disease.

How the Study Was Run

The set-up was randomized, parallel-group and quadruple-blind.

The participants were allocated by chance, so the Thymosin Beta-4 (full length) group and the comparison group should start out alike.

Groups ran in parallel: each of the participants stayed in one arm throughout.

As a double-blind Thymosin Beta-4 (full length) study, the assignments were hidden from both participants and investigators until the end.

Those kept unaware of assignments: participant, care provider, investigator and outcomes assessor.

It started in 2016-11 with completion listed for 2017-09.

It ran at 10 sites in United States (10).

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Change in Ocular Discomfort (time frame: Day 29). Change in Fluorescein Staining (time frame: Day 29).

It also tracked 10 secondary outcomes, for example Fluorescein Staining (Ora Calibra™ Scale) at Visits 3, 4, and 5 (Change From Pre-CAE to Post-CAE, Pre- and Post-CAE), Fluorescein Staining (Ora Calibra™ Scale) at Visits 3, 4, and 5 (Change From Pre-CAE to Post-CAE, Pre- and Post-CAE) in a Subgroup, Lissamine Green Staining (Ora Calibra™ Scale) at Visits 3, 4, and 5 (Pre- and Post-CAE), Tear Film Break-Up Time, Ocular Protection Index (OPI 2.0) at Visit 5 (Pre-CAE) and Unanesthetized Schirmer's Test at Visit 5 (Pre-CAE).

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Thymosin Beta-4 (full length) in 601 people.

With 601 participants it is a large trial for this field.

The trial is marked completed; results are posted on the registry, and this page does not restate them.

More context: the Thymosin Beta-4 (full length) compound page, all human trials.