ClinicalTrials.gov recorded primary completion on 8 November 2020 for a Phase 3 trial of RGN-259 ophthalmic solution in dry eye. The ARISE-3 study enrolled 700 participants and compared RGN-259 with placebo on safety and efficacy measures, including corneal staining and ocular discomfort.

Background

RGN-259 is an ophthalmic solution being assessed for the treatment of dry eye syndromes and dry eye. The registered study was designed to compare the safety and efficacy of RGN-259 with placebo for signs and symptoms of dry eye. The supplied record does not provide additional information about the drug’s class, mechanism, prior approvals, or the prevalence of the condition.

Trial design

ARISE-3 was a Phase 3 study involving participants with dry eye syndromes and dry eye. The trial compared an experimental RGN-259 group with a placebo comparator group. Its stated objective was to assess the safety and efficacy of RGN-259 ophthalmic solution for dry eye signs and symptoms. The ClinicalTrials.gov record listed the overall status as completed.

The reported measures included change from baseline in inferior corneal staining from pre-CAE® to post-CAE® at Day 15, using the Ora Calibra® Scale, and change from baseline in ocular discomfort at Day 15 before CAE®, using the Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire. The record also listed fluorescein staining measurements at Visits 3 and 4.

Key results

  • For inferior corneal staining at Day 15, the mean change was -0.41 score with a standard deviation of 0.841 for RGN-259, compared with -0.46 score and a standard deviation of 0.804 for placebo.
  • For ocular discomfort at Day 15 before CAE®, the mean change was -0.4 score with a standard deviation of 1.12 for RGN-259 and -0.4 score with a standard deviation of 1.14 for placebo.
  • Fluorescein staining measurements listed mean values of 8.46 versus 8.36, 8.20 versus 8.06, 10.11 versus 9.95, and 1.91 versus 1.92 for RGN-259 and placebo, respectively. The corresponding standard deviations ranged from 2.262 to 3.052.

The supplied data include no p-values, confidence intervals, statistical analyses, primary-outcome entries, or adverse-event summary.

What this means

Primary completion indicates that the trial’s primary data-collection stage was recorded as complete. The available measurements show closely similar reported mean values between RGN-259 and placebo for the listed corneal-staining and ocular-discomfort measures.

These data alone do not establish whether RGN-259 met a prespecified primary endpoint, demonstrate a statistically significant treatment difference, or support a regulatory approval or label change. They also do not provide a comparative safety conclusion because no adverse-event summary was supplied.

Source

Source: ClinicalTrials.gov, registry record for “Assessment of the Safety and Efficacy of RGN-259 Ophthalmic Solutions for Dry Eye Syndrome: ARISE-3,” NCT03937882, with primary completion dated 8 November 2020. The record is available at clinicaltrials.gov/study/NCT03937882.