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Comparative Study of Thymosin Beta 4 Eye Drops vs. Vehicle in the Treatment of Severe Dry Eye
Plain-language guide to NCT01393132: phase 2 randomized trial of TB-500 (Thymosin Beta-4 fragment) and Thymosin Beta-4 (full length), 9 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT01393132
- Phase
- phase 2
- Status
- completed
- Start
- 2011-03
- Completion (planned or actual)
- 2012-12
- Participants
- 9 (actual)
- Design
- randomized, triple-blind, treatment
- Conditions studied
- Dry Eye; Sjogren's Syndrome; Graft vs. Host Disease
- Results posted
- yes
What This Study Did, in Plain Language
What Was Tested
The trial (phase 2) is built around TB-500 (Thymosin Beta-4 fragment) and Thymosin Beta-4 (full length).
It had two arms (groups): Thymosin Beta 4 eye drops (experimental) and Vehicle Control (placebo comparator).
It is a preservative-free, sterile eye drop solution containing Tβ4 for direct instillation into each eye, six times daily for 28 days.
It is composed of the same excipients as RGN-259 but does not contain Tβ4 for direct instillation into each eye, six times daily for 28 days.
The registry classes the interventions as drug.
Who Took Part
The registry lists 9 actual participants took part.
It was open to people of any sex aged from 18 years up to 90 years.
Healthy volunteers were not accepted; participants needed the condition being studied.
Examples of who could join: Schirmers of \< 5 mm at 5 minutes. TFBUT: less than 10 seconds. Ocular Surface Disease Index of \> 50. Presumed best corrected vision of 20/60 or better.
The full record lists 5 inclusion and 10 exclusion criteria; among the exclusions: pregnancy or lactation; monocular status; punctal occlusion within 30 days.
How the Study Was Run
Design: randomized, parallel-group and triple-blind.
Random assignment meant chance, not the researchers, decided who got TB-500 (Thymosin Beta-4 fragment) and who got the comparison, which limits bias.
Groups ran in parallel: each of the participants stayed in one arm throughout.
Blinding on both sides kept the participants and researchers unaware of who received TB-500 (Thymosin Beta-4 fragment).
Those kept unaware of assignments: participant, care provider and investigator.
It started in 2011-03 with completion listed for 2012-12.
It ran at 1 site in United States.
Its stated primary purpose is treatment.
What Was Measured
Primary outcome: Safety (time frame: Day 1, Day 14, Day 28 and Day 56).
It also tracked 3 secondary outcomes, for example Ocular Discomfort Index and Tear Film Break up Time.
What This Means in Plain Language
Put simply, this is a phase 2, randomized trial of TB-500 (Thymosin Beta-4 fragment) and Thymosin Beta-4 (full length) in 9 people.
Its size is small, so on its own it can only give an early look.
The trial is marked completed; results are posted on the registry, and this page does not restate them.
More context: the TB-500 (Thymosin Beta-4 fragment) compound page and the Thymosin Beta-4 (full length) compound page, all human trials.
Our Notes on the Compounds
TB-500 (Thymosin Beta-4 fragment): A synthetic fragment of thymosin beta-4 (43-aa parent, too large for oral use).
Thymosin Beta-4 (full length): The natural 43-amino-acid actin-binding peptide behind the TB-500 name; tested in human trials for eye, skin-wound and heart conditions.
Related Pages
Source: ClinicalTrials.gov record. This explanation is written by PeptideWhiz from the public record. For research and education only. Not medical advice; no dosing information is given.