Peptide Library

Human study PLS-00235

Assessment of the Safety and Efficacy of RGN-259 Ophthalmic Solutions for Dry Eye Syndrome : ARISE-2

Other design · 601 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 RGN-259 Ophthalmic Solutions for Dry Eye Syndrome : ARISE-2registry entry · NCT02974907 (COMPLETED, results posted, planned enrollment 601)

Design and participants

Design
Other design
Population
People with dry eye syndrome. Age and other eligibility criteria are not given in the record.
Conditions
Dry Eye Syndrome
Planned enrollment (registry)
601
Enrolled
601
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, listed in the registry interventions as Tβ4 / Thymosin Beta 4, given as an ophthalmic solution · ophthalmic (eye drops) · Not reported assigned
  • Placebo / vehicle control (comparator) · Placebo described as vehicle control · 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: The title states that safety was assessed. No monitoring procedures or adverse event data are given in the record.

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: The record holds only registry fields: no outcome definitions, result values or adverse event data are available, despite the has_results flag.
  • inadequate randomization: The record does not state whether or how participants were allocated to RGN-259 or vehicle, so randomization cannot be verified.
  • inadequate blinding: The record gives no information on masking of participants, investigators or outcome assessors.
  • funding or conflicts: No sponsor, funding source or conflicts of interest are stated in the record.
  • selective reporting: The registered primary and secondary outcomes are not listed, so reporting cannot be compared with prespecified outcomes.

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

Claims this study informs

Where each value comes from

  • arms: NCT NCT02974907, registry (interventions) · extracted by AI (automated, not verified by a person)
  • arms: NCT NCT02974907, title (study title (ophthalmic solutions)) · extracted by AI (automated, not verified by a person)
  • design: NCT NCT02974907, registry (phases, study_type, status) · extracted by AI (automated, not verified by a person)
  • limitations: NCT NCT02974907, registry (has_results flag with no result fields present) · extracted by AI (automated, not verified by a person)
  • participants: NCT NCT02974907, registry (enrollment, enrollment_type) · extracted by AI (automated, not verified by a person)
  • population: NCT NCT02974907, registry (conditions) · 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).