Peptide Library

Human study PLS-00226

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

Other design · 18 participants enrolled

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.

  • Assessment of the Safety and Efficacy Study of RGN-259 Ophthalmic Solutions for Neurotrophic Keratopathy : SEER-1registry entry · NCT02600429 (TERMINATED, results posted, planned enrollment 18)

Design and participants

Design
Other design
Population
People with neurotrophic keratopathy (registry condition field); no further eligibility details in the record.
Conditions
Neurotrophic Keratopathy
Planned enrollment (registry)
18
Enrolled
18
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.

  • RGN-259 (Tβ4 ophthalmic solution) (intervention) · thymosin-beta-4 (formulation) · RGN-259, an ophthalmic solution formulation of thymosin β4, as listed in the registry interventions · ophthalmic (topical eye drops) · Not reported assigned
  • Placebo / vehicle control (comparator) · Placebo / vehicle control ophthalmic solution, as listed in the registry interventions · placebo · ophthalmic (topical 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: The title describes an assessment of safety, but the record gives no 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 a registry entry is available. The posted results are not included in the record, so no outcome values can be assessed.
  • small or imprecise: Actual enrollment was 18 participants, too few for precise efficacy or safety estimates.
  • incomplete follow up: Registry status is TERMINATED. Early stopping may have left incomplete follow-up or an underpowered analysis.
  • inadequate randomization: The record does not state whether or how participants were randomized, or whether allocation was concealed.
  • inadequate blinding: Masking is not described in the registry fields provided, although a vehicle control was used.
  • inappropriate population: The population is neurotrophic keratopathy, which differs from dry eye disease addressed by one claim question.
  • abstract only: Only a registry record is available. It gives no outcome data, adverse event data, methods details or publication.

No risk-of-bias assessment has been published for this study’s results.

Claims this study informs

  • Insufficient information to assess Adverse events, serious adverse events and discontinuations

Where each value comes from

  • arms: NCT NCT02600429, registry (interventions field) · extracted by AI (automated, not verified by a person)
  • design: NCT NCT02600429, registry (study_type and phases fields) · extracted by AI (automated, not verified by a person)
  • limitations: NCT NCT02600429, registry (status and enrollment fields) · extracted by AI (automated, not verified by a person)
  • participants: NCT NCT02600429, registry (enrollment and enrollment_type fields) · extracted by AI (automated, not verified by a person)
  • population: NCT NCT02600429, 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).