Human study PLS-00243

Assessment of the Safety and Efficacy of 0.1% RGN-259 Ophthalmic Solution for the Treatment of NK: SEER-2

Other design · 70 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 of 0.1% RGN-259 Ophthalmic Solution for the Treatment of NK: SEER-2registry entry · NCT05555589 (COMPLETED, no results posted, planned enrollment 70)

Design and participants

Design
Other design
Population
People with neurotrophic keratopathy (NK). The record gives no further eligibility details.
Conditions
Neurotrophic Keratopathy
Planned enrollment (registry)
70
Enrolled
70
Randomized
Not reported
Completed follow-up
Not reported
Funding
Not stated in record.
Authors’ conflicts
Not stated in record.

Intervention and comparator

What each group received. Related peptides, analogs and combinations are never treated as the compound itself.

  • RGN-259 (Thymosin beta 4 ophthalmic solution) (intervention) · thymosin-beta-4 (formulation) · RGN-259, an ophthalmic solution of thymosin beta 4 (timbetasin). Dose not reported here. · ophthalmic (topical eye drops) · Not reported assigned
  • Placebo (vehicle control) (comparator) · Vehicle control ophthalmic solution · 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.

Efficacy in neurotrophic keratopathy (specific measure not stated in record)

unclear outcome · patient-important

  • No results reported.

Safety (adverse events; specific measures not stated in record)

unclear outcome · safety

  • No results reported.

Adverse events

None reported. That is not evidence of safety.

Monitoring: The title says safety was assessed. The record does not describe how it was monitored.

The authors concluded (paraphrased): No results or conclusions are available; the record is a registry entry without posted results.

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

  • abstract only: Only the ClinicalTrials.gov registration is available. It has no posted results, no outcome definitions and no full publication.
  • selective reporting: The registry status is COMPLETED but has_results is false, so outcome data are not publicly reported.
  • other: The record does not state allocation method, randomization or blinding, so the design cannot be confirmed as randomized.
  • inappropriate population: The participants have neurotrophic keratopathy, not dry eye disease, which limits use for dry eye claims.

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

Claims this study informs

Where each value comes from

  • arms: NCT NCT05555589, registry (interventions field) · extracted by AI (automated, not verified by a person)
  • design: NCT NCT05555589, registry (phases and study_type fields) · extracted by AI (automated, not verified by a person)
  • outcomes: NCT NCT05555589, title (study title (safety and efficacy)) · extracted by AI (automated, not verified by a person)
  • participants: NCT NCT05555589, registry (enrollment and enrollment_type fields) · extracted by AI (automated, not verified by a person)
  • population: NCT NCT05555589, 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).