Peptide Library

Human study PLS-00237

Assessment of the Safety and Efficacy of RGN-259 Ophthalmic Solutions for Dry Eye Syndrome: ARISE-3

Other design · 700 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-3registry entry · NCT03937882 (COMPLETED, results posted, planned enrollment 700)

Design and participants

Design
Other design
Population
People with dry eye syndrome (registered conditions: Dry Eye Syndromes, Dry Eye); eligibility details not in record.
Conditions
Dry Eye Syndromes, Dry Eye
Planned enrollment (registry)
700
Enrolled
700
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 ophthalmic solution, listed in the registry interventions as Tβ4 / Thymosin Beta 4 · 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.

Adverse events

None reported. That is not evidence of safety.

Monitoring: The title states safety was assessed. Specific safety measures are not described 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: Only stored registry fields are available. The registry indicates results were posted, but no outcome values, adverse event counts or analyses are in the record.
  • inadequate randomization: The stored registry fields do not state whether allocation was randomized, how it was concealed, or whether masking was used.
  • selective reporting: The record lists no registered primary or secondary outcome measures, so reporting against pre-specified outcomes cannot be checked.
  • funding or conflicts: Sponsor, funding source and investigator conflicts of interest are not reported in the record.
  • abstract only: No publication or abstract is in the record, so randomization, blinding and analysis methods cannot be verified.

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

Claims this study informs

Where each value comes from

  • arms: NCT NCT03937882, registry (interventions) · extracted by AI (automated, not verified by a person)
  • design: NCT NCT03937882, registry (phases, study_type, status) · extracted by AI (automated, not verified by a person)
  • limitations: NCT NCT03937882, registry (has_results field with no results content) · extracted by AI (automated, not verified by a person)
  • outcomes: NCT NCT03937882, title (full title (safety and efficacy)) · extracted by AI (automated, not verified by a person)
  • participants: NCT NCT03937882, registry (enrollment, enrollment_type) · extracted by AI (automated, not verified by a person)
  • population: NCT NCT03937882, 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).