Intraoperative Floppy Iris Syndrome Undergoing Intraocular Lens Replacement Surgery

PHASE3TerminatedINTERVENTIONAL
Enrollment

18

Participants

Timeline

Start Date

February 28, 2014

Primary Completion Date

August 31, 2014

Study Completion Date

August 31, 2014

Conditions
Intraocular Lens ReplacementIntraoperative Floppy Iris Syndrome
Interventions
DRUG

Part 1 OMS302

OMS302 drug product will be supplied as a sterile, clear colorless liquid, free from particulates of foreign matter. Each vial contains a nominal 4.5-mL solution containing 60.75 mM phenylephrine HCl (12.37 mg/mL) and 11.25 mM ketorolac trometamol (4.24 mg/mL) formulated in a 20 mM sodium citrate buffer (pH 6.3 ± 0.5). For administration to patients, 4.0 mL of the drug product is added to a 500-mL bottle of commercially available irrigation solution.

DRUG

Part 2 OMS302

OMS302 drug product will be supplied as a sterile, clear colorless liquid, free from particulates of foreign matter. Each vial contains a nominal 4.5-mL solution containing 60.75 mM phenylephrine HCl (12.37 mg/mL) and 11.25 mM ketorolac trometamol (4.24 mg/mL) formulated in a 20 mM sodium citrate buffer (pH 6.3 ± 0.5). For administration to patients, 4.0 mL of the drug product is added to a 500-mL bottle of commercially available irrigation solution.

DRUG

Part 2 Placebo

Placebo drug product is a sterile, clear colorless liquid, free from particulates of foreign matter. Each vial contains a nominal 4.5 mL of solution containing 20 mM sodium citrate buffer (pH 6.3 ± 0.5). For administration to patients, 4.0 mL of the drug product is added to a 500-mL bottle of commercially available irrigation solution.

Trial Locations (2)

Unknown

Omeros Investigational Site, Vienna

Omeros Investigational Site, Bochum

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Omeros Corporation

INDUSTRY

NCT02093689 - Intraoperative Floppy Iris Syndrome Undergoing Intraocular Lens Replacement Surgery | Biotech Hunter | Biotech Hunter