Peptide LibraryHuman study PLS-00215
Safety and Efficacy of Thymosin Beta 4 Ophthalmic Solution in Patients With Dry Eye
Version 1 · published November 8, 2026 · evidence through November 8, 2026 · research snapshot 2026.1.1 · methodology ev-1 · Automated assessment by AI (claude-opus-5-5 and claude-sonnet-5-5), not reviewed by a person.
Reports of this study
Every publication, registration and abstract describing this one study. Participants are counted once.
- Safety and Efficacy of Thymosin Beta 4 Ophthalmic Solution in Patients With Dry Eyeregistry entry · NCT01387347 (COMPLETED, results posted, planned enrollment 72)
Design and participants
- Design
- Other design
- Population
- Patients with dry eye syndrome / dry eye
- Conditions
- Dry Eye Syndrome, Dry Eye
- Planned enrollment (registry)
- 72
- Enrolled
- 72
- Randomized
- Not reported
- Completed follow-up
- Not reported
Intervention and comparator
What each group received. Related peptides, analogs and combinations are never treated as the compound itself.
- Thymosin beta 4 ophthalmic solution (RGN-259) (intervention) · thymosin-beta-4 (formulation) · RGN-259, an eye drop formulation of thymosin beta 4 · ophthalmic (eye drops) · Not reported assigned
- Vehicle control (placebo) (comparator) · Placebo / vehicle control eye drops · placebo · ophthalmic (eye drops) · Not reported assigned
What the authors reported
As stated in the sources. This is the authors’ account, not Peptide Library’s assessment.
Adverse events
None reported. That is not evidence of safety.
Monitoring: Safety is named as an aim in the registered title. The record gives no specific monitoring procedures.
Peptide Library’s assessment
An automated assessment, made by AI separately from the authors’ conclusions and not reviewed by a person. How risk of bias is assessed.
Limitations
- other: Only the registry entry is available, and it includes no outcome measures, results, adverse event data or conclusions.
- inadequate randomization: The record does not state the allocation method, so it is unknown whether participants were randomized.
- inadequate blinding: The record does not describe masking, even though a vehicle control is listed.
- selective reporting: Registered primary and secondary outcomes are not given in the record, so selective reporting cannot be assessed.
- small or imprecise: This is a phase 2 study with 72 participants enrolled in total, split across arms.
No risk-of-bias assessment has been published for this study’s results.
Claims this study informs
- Improves dry eye signs and symptoms: not eligible (insufficient data) for “Ocular discomfort and corneal staining”
- Is safe for human administration: not eligible (insufficient data) for “Adverse events, serious adverse events and discontinuations”
Where each value comes from
- arms: NCT NCT01387347, registry (interventions field) · extracted by AI (automated, not verified by a person)
- design: NCT NCT01387347, registry (study_type and phases fields) · extracted by AI (automated, not verified by a person)
- limitations: NCT NCT01387347, registry (absence of outcome and result fields) · extracted by AI (automated, not verified by a person)
- participants: NCT NCT01387347, registry (enrollment and enrollment_type fields) · extracted by AI (automated, not verified by a person)
- population: NCT NCT01387347, registry (conditions field) · extracted by AI (automated, not verified by a person)
Version 1 · published November 8, 2026 · evidence through November 8, 2026 · research snapshot 2026.1.1 · methodology ev-1 · Automated assessment by AI (claude-opus-5-5 and claude-sonnet-5-5), not reviewed by a person.
These assessments describe published research. Records marked automated were produced by AI under the published methodology and have not been reviewed by a person; they can contain errors. None of this is medical advice, not a statement about any product’s safety for human use, and not a regulatory approval. Peptide Library’s vendor and partner relationships play no part in them (editorial independence).