Peptide Library

Human study PLS-00225

Assessment of the Safety and Efficacy of RGN-259 Ophthalmic Solutions for Dry Eye Syndrome: ARISE-1

Other design · 317 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-1registry entry · NCT02597803 (COMPLETED, no results posted, planned enrollment 317)

Design and participants

Design
Other design
Population
People with dry eye syndrome. Eligibility criteria are not given in the record.
Conditions
Dry Eye Syndrome
Planned enrollment (registry)
317
Enrolled
317
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 vehicle control ophthalmic solution · 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. The record gives no details of safety monitoring.

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

  • selective reporting: The registry marks the study completed, but has_results is false and the record contains no results or publication, so no findings can be appraised.
  • other: The record specifies no outcome measures, timepoints, allocation method or masking. Only the title's mention of safety and efficacy is available.
  • funding or conflicts: The record states no sponsor, funding source or conflicts. RGN-259 is a proprietary product name, so the study is likely developer-sponsored, but this is not stated.

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

Claims this study informs

Where each value comes from

  • arms: NCT NCT02597803, registry (interventions field) · extracted by AI (automated, not verified by a person)
  • design: NCT NCT02597803, registry (study_type, phases and interventions fields) · extracted by AI (automated, not verified by a person)
  • limitations: NCT NCT02597803, registry (status and has_results fields) · extracted by AI (automated, not verified by a person)
  • outcomes: NCT NCT02597803, title (study title (safety and efficacy)) · extracted by AI (automated, not verified by a person)
  • participants: NCT NCT02597803, registry (enrollment and enrollment_type fields) · extracted by AI (automated, not verified by a person)
  • population: NCT NCT02597803, 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).