At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 601 enrolled
Drug / intervention
RGN-259 +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Multi-Center, Randomized, Double Masked, Placebo Controlled Clinical Study to Assess the Safety and Efficacy of RGN-259 Ophthalmic Solutions for the Treatment of Dry Eye : ARISE-2
In Brief
A Phase 3 clinical trial evaluating RGN-259 and Placebo for Dry Eye Syndrome. Completed, enrolled 601 participants across 1 site.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDry Eye Syndrome
CountriesUnited States
Collaborators--
Timeline
Phase 3CompletedFinished
2017201820192020202120222023202420252026
Enrollment StartNov 2016
First PostedNov 2016
Primary CompletionSep 2017
Study CompletionMar 2018
TodayJul 2026
First PostedNov 29, 2016
Enrollment StartNov 1, 2016
Primary CompletionSep 1, 2017
Study CompletionMar 1, 2018
TodayJul 2, 2026
Enrollment to primary: 10 monthsPosted 9.6 years ago
Interventions
RGN-259drug
A preservative-free, sterile eye drop solution containing Tβ4 for direct instillation into each eye, four times a day (QID) for 28 days
Placebodrug
It is composed of the same excipients as RGN-259 but does not contain Tβ4