NCT02132312

A Randomized Study in Children Ages Birth Through Three Years Undergoing Unilateral Cataract Extraction With or Without Lens Replacement

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 78 (actual)
• Sponsor: Omeros Corporation · Industry
• Sex: All
• Age: 1 Day – 47 Months
• Healthy volunteers: Not accepted

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.

Detailed description

This study is a randomized, parallel-group, double-masked, phenylephrine-controlled study of OMS302 in young children ages birth through three years undergoing unilateral cataract extraction with or without lens replacement. Administration of test irrigation solutions will take place in a double-masked fashion. Intraoperative pupil size will be determined by measurement of pupil diameter from still photos captured from video recordings of the procedure. Pupil diameter measurements will be performed immediately prior to the initial incision and at one-minute intervals until the end of the procedure (wound closure). Pain will be assessed by the Alder Hey Triage Pain Score.

Conditions

• Unilateral Cataract Extraction
• Congenital Cataract

Interventions

Type	Name	Description
DRUG	OMS302
DRUG	Phenylephrine HCl

Timeline

• Start date: 2014-07-01
• Primary completion: 2016-09-12
• Completion: 2016-09-12
• First posted: 2014-05-07
• Last updated: 2021-07-22
• Results posted: 2021-07-22

Locations

11 sites across 1 country: United States