Assessment of the Safety and Efficacy Study of RGN-259 Ophthalmic Solutions for Neurotrophic Keratopathy : SEER-1

What Was Tested

In this phase 3 trial, researchers set out to test Thymosin Beta-4 (full length).

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

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

Neurotrophic keratopathy (NK) is a degenerative corneal disease that occurs as a result of partial or total impairment of trigeminal innervation.

Who Took Part

18 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 male or female of any race, at least 18 years of age. Have provided verbal and written informed consent. Be able and willing to follow instructions, including participation in all study assessments and visits;.

The full record lists 4 inclusion and 8 exclusion criteria; among the exclusions: have a lid function abnormality (ex. lagophthalmos) which, in the opinion of the investigator, is the primary cause of the persistent epithelial defect;; be diagnosed with ongoing ocular infection (bacterial, viral or fungal) or active inflammation (e.g. follicular conjunctivitis) not related to nk; anticipate the use of fluoroquinolone-containing antibiotic eye drops during the study;.

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 2015-09-17 with completion listed for 2019-11-20.

It ran at 11 sites in United States (11).

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Percentage of Subjects Achieving Complete Healing at Day 29.

It also tracked 5 secondary outcomes, for example Percentage of Subjects Achieving Complete Healing at 8, 15, 22, 36, 43 Days, Epithelial Defect Measurement and Classification as Stage 1, 2 or 3 Using Mackie Classification, Tear Film Break-up Time at 29, 36, 43 Days and Visual Acuity(logMAR) at 8, 15, 22, 29, 36, 43 Days.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Thymosin Beta-4 (full length) in 18 people.

Its size is small, so on its own it can only give an early look.

It ended early (terminated); 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.