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

What Was Tested

This registered phase 2, phase 3 trial tested Thymosin Beta-4 (full length).

It had three arms (groups): one (experimental), Placebo (placebo comparator) and one (experimental).

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

317 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 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.

The full record lists 7 inclusion and 9 exclusion criteria; among the exclusions: 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;.

How the Study Was Run

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

Random assignment meant chance, not the researchers, decided who got Thymosin Beta-4 (full length) and who got the comparison, which limits bias.

The Thymosin Beta-4 (full length) group and the comparison group ran side by side rather than switching.

Blinding on both sides kept the participants and researchers unaware of who received Thymosin Beta-4 (full length).

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

It started in 2015-09 with completion listed for 2016-06.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Total corneal fluorescein staining score at day29. Total ocular discomfort score at day29.

It also tracked 3 secondary outcomes, for example Tear film break-up time at day 8, 15, 29, Unanesthetized Schirmer's Test at day 8, 15, 29 and Ocular Surface Disease Index (OSDI)© at day 8, 15, 29.

What This Means in Plain Language

Put simply, this is a phase 2, phase 3, randomized trial of Thymosin Beta-4 (full length) in 317 people.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

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