Phase 3
Completed N=601
Assessment of the Safety and Efficacy of RGN-259 Ophthalmic Solutions for Dry Eye Syndrome : ARISE-2
Source: ClinicalTrials.gov NCT02974907 ↗Enrolled (actual)
601
Serious AEs
0.8%
Results posted
Jan 2022
Primary outcomePrimary: Ocular Discomfort — 0.07; -0.04 score on a scale
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
Summary
The objective of this study is to compare the safety and efficacy of RGN-259 Ophthalmic Solutions to placebo for the treatment of the signs and symptoms of dry eye.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Ocular Discomfort |
0.07; -0.04 | — |
| PRIMARY Corneal Fluorescein Staining |
— | — |
| SECONDARY Corneal Fluorescein Staining |
— | — |
| SECONDARY Unanesthetized Schirmer's Test |
— | — |
| SECONDARY Ocular Surface Disease Index (OSDI)© |
— | — |
| SECONDARY Tear Film Break-Up Time |
— | — |
Eligibility Criteria
Inclusion Criteria
- Be at least 18 years of age;
- Provide written informed consent;
- Have a subject reported history of dry eye for at least 6 months
- Have a history of use or desire to use eye drops for dry eye symptoms within 6 months
Exclusion Criteria
- Have any clinically significant slit-lamp findings at Visit 1 that may include active blepharitis, meibomian gland dysfunction (MGD), lid margin inflammation or active ocular allergies that require therapeutic treatment, and/or in the opinion of the investigator may interfere with study parameters;
- Be diagnosed with an ongoing ocular infection (bacterial, viral, or fungal), or active ocular inflammation at Visit 1;
- Have ab uncontrolled systemic disease:
Data sourced from ClinicalTrials.gov (NCT02974907). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.