At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 78 enrolled
Drug / intervention
OMS302 +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 Randomized, Double-Masked, Parallel-Group, Phenylephrine-Controlled Study of the Effect of OMS302 Added to Standard Irrigation Solution on Intraoperative Pupil Diameter and Acute Postoperative Pain in Children Ages Birth Through Three Years Undergoing Unilateral Cataract Extraction With or Without Lens Replacement
In Brief
A Phase 3 clinical trial evaluating OMS302 and Phenylephrine HCl for Unilateral Cataract Extraction and Congenital Cataract. Completed, enrolled 78 participants across 11 sites.
Detailed Summary
The purpose of this study is to evaluate the effect of OMS302 compared to phenylephrine when administered in irrigation solution during cataract extraction on intraoperative pupil diameter, acute postoperative pain, and safety in children birth through 3 years.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--
Timeline
Phase 3CompletedFinished
201520162017201820192020202120222023202420252026
First PostedMay 2014
Enrollment StartJul 2014
Primary CompletionSep 2016
TodayJul 2026
First PostedMay 7, 2014
Enrollment StartJul 1, 2014
Primary CompletionSep 12, 2016
TodayJul 2, 2026
Enrollment to primary: 2.2 yearsPosted 12.2 years ago
Interventions
OMS302drug
Phenylephrine HCldrug