Assessment of the Safety and Efficacy of RGN-259 Ophthalmic Solutions for Dry Eye Syndrome: ARISE-3

What Was Tested

This registered phase 3 trial tested 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 Thymosin beta 4.

It is composed of the same excipients as RGN-259 but does not contain Thymosin beta 4.

The registry classes the interventions as drug.

Who Took Part

700 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 21 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 used any eye drops within 2 hours of visit 1;.

How the Study Was Run

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

Because people in this Thymosin Beta-4 (full length) study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

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 2019-05-24 with completion listed for 2020-11-08.

It ran at 20 sites in United States (20).

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Change From Baseline in Ocular Discomfort at Day 15 (Visit 4) Pre-CAE® Using the Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire (time frame: Day 15).

It also tracked 9 secondary outcomes, for example Fluorescein Staining (Ora Calibra® Scale) at Visits 3 and 4 (Change From Pre-CAE® to Post-CAE®, Pre and Post-CAE®), Lissamine Green Staining (Ora Calibra® Scale) at Visits 3 and 4 (Change From Pre-CAE® to Post-CAE®, Pre- and Post-CAE®), Tear Film Break-Up Time (TFBUT©) at Visits 3 and 4 (Pre- and Post-CAE®), Unanesthetized Schirmer's Test at Visit 3, Visit 4 (Pre-CAE®), Drop Comfort Assessment After Randomization at Visit 2 and Ocular Surface Disease Index (OSDI)© at Visits 3 and 4 (Pre-CAE®).

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Thymosin Beta-4 (full length) in 700 people.

With 700 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.