Safety, Efficacy and Pharmacokinetics of OMS302 in Subjects Undergoing Intraocular Lens Replacement With Phacoemulsification - Full Text View

Purpose

The purpose of this study is to determine the safety, efficacy and pharmacokinetics of OMS302 (the study drug) for maintaining intraoperative mydriasis and preventing post operative pain in individuals undergoing Intraocular Lens Replacement (ILR) surgery.

Condition	Intervention	Phase
Intraocular Lens Replacement	Drug: OMS302 Drug: Placebo	Phase 3

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	A Phase 3 Randomized, Double-Masked, Placebo-Controlled Study of the Pharmacokinetics of OMS32 and the Effect of OMS302 on Intraoperative Pupil Diameter and Early Postoperative Pain in Subjects Undergoing Intraocular Lens Replacement With Phacoemulsification

Further study details as provided by Omeros Corporation:

Primary Outcome Measures:

Intraoperative pupil diameter [ Time Frame: Intraoperative ] [ Designated as safety issue: No ]
Change in pupil diameter over time from surgical baseline to end of the surgical procedure determined by video capture during ILR.
Pain during the early postoperative period [ Time Frame: 12 hours ] [ Designated as safety issue: No ]
Postoperative pain as measured by the Visual Analog Scale at 2, 4, 6, 8 and 10-12 hours after ILR surgery.

Secondary Outcome Measures:

Intraoperative pupil diameter [ Time Frame: Intraoperative ] [ Designated as safety issue: No ]
Proportion of subjects having a pupil diameter >= 6mm at cortical clean-up.
Intraoperative pupil diameter [ Time Frame: Intraoperative ] [ Designated as safety issue: No ]
Proportion of subjects having a pupil diameter < 6mm anytime during surgery.
Moderate-to-severe pain pain during the early postoperative period [ Time Frame: 12 hours ] [ Designated as safety issue: No ]
Proportion of subjects reporting moderate-to-severe pain at any timepoints during 12 hours postoperatively.
No Pain during the early postoperative period [ Time Frame: 12 hours ] [ Designated as safety issue: No ]
Proportion of subjects reporting no pain at all timepoints during 12 hours postoperatively.
Pain during the late postoperative period [ Time Frame: 14 days ] [ Designated as safety issue: No ]
Postoperative pain as measured by the Visual Analog Scale at 24 and 48 hours, and Days 3-7 and 14 after ILR surgery.
Safety as measured by adverse events [ Time Frame: 90 days ] [ Designated as safety issue: Yes ]
Safety as assessed by the incidence of adverse events and serious adverse events through day 90.
Postoperative photophobia [ Time Frame: 14 days ] [ Designated as safety issue: No ]
Photophobia as measured by the photophobia scale of the NRS at 2, 6, 24, and 48 hours, and 7 and 14 days after surgery.
Postoperative best-corrected visual acuity (BVCA) [ Time Frame: 90 days ] [ Designated as safety issue: Yes ]
BVCA as measured using the Early Treatment Diabetic Retinopathy Study method at 24 and 48 hours, and 7, 14 and 90 days after surgery.
Postoperative inflammation [ Time Frame: 90 days ] [ Designated as safety issue: No ]
Postoperative inflammation as measured using the Summed Ocular Inflammation Score at 24 and 48 hours, and 7, 14 and 90 days after surgery.
Systemic Pharmacokinetics of OMS302 [ Time Frame: 24 hours ] [ Designated as safety issue: Yes ]
Pharmacokinetics will be evaluated using plasma concentrations of OMS302 at baseline and at approximately 15 and 30 minutes and 1, 2, 4, 8 and 24 hours following initiation of study drug administration.

Enrollment:	416
Study Start Date:	April 2012
Study Completion Date:	January 2013
Primary Completion Date:	November 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: OMS302 OMS302 diluted in Balanced Salt Solution and administered as irrigation solution during Intraocular Lens Replacement surgery.	Drug: 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 and 11.25 mM ketorolac tromethamine formulated in a 20mM sodium citrate buffer (pH 6.3 +/- 0.5). For administration to patients, 4.4 mL of the drug product is added to a 500 mL bottle of commercially available BSS solution through a syringe filter. This will achieve 4.0 mL of the drug product in a 500 mL bottle of BSS solution.
Placebo Comparator: Placebo Placebo diluted in Balanced Salt Solution and administered as irrigation solution during Intraocular Lens Replacement surgery.	Drug: Placebo Placebo 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 20mM sodium citrate buffer (pH 6.3 +/- 0.5). For administration to patients, 4.4 mL of the drug product is added to a 500 mL bottle of commercially available BSS solution through a syringe filter. This will achieve 4.0 mL of the drug product in a 500 mL bottle of BSS solution.

Arms

Assigned Interventions

Experimental: OMS302

OMS302 diluted in Balanced Salt Solution and administered as irrigation solution during Intraocular Lens Replacement surgery.

Drug: 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 and 11.25 mM ketorolac tromethamine formulated in a 20mM sodium citrate buffer (pH 6.3 +/- 0.5). For administration to patients, 4.4 mL of the drug product is added to a 500 mL bottle of commercially available BSS solution through a syringe filter. This will achieve 4.0 mL of the drug product in a 500 mL bottle of BSS solution.

Placebo Comparator: Placebo

Placebo diluted in Balanced Salt Solution and administered as irrigation solution during Intraocular Lens Replacement surgery.

Drug: Placebo

Placebo 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 20mM sodium citrate buffer (pH 6.3 +/- 0.5). For administration to patients, 4.4 mL of the drug product is added to a 500 mL bottle of commercially available BSS solution through a syringe filter. This will achieve 4.0 mL of the drug product in a 500 mL bottle of BSS solution.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Competent and willing to voluntarily provide informed consent
18 years of age or older
In good general health needing to undergo cataract extraction or lens extraction with lens replacement surgery in one eye, under topical anesthesia

Exclusion Criteria:

No allergies to the medications and/or the active ingredients of any of the study medications
No medications with the same activities of the active ingredients in OMS302 for defined time intervals prior to and after surgery
No other significant eye injuries, eye conditions or general medical conditions likely to interfere with the evaluation of the study medication

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01579565

Locations

United States, Arizona

Chandler, Arizona, United States, 85224
United States, California

Los Angeles, California, United States, 90013
United States, Florida

Fort Myers, Florida, United States, 33901
United States, Massachusetts

Boston, Massachusetts, United States, 02114
United States, Missouri

Saint Louis, Missouri, United States, 63131

Washington, Missouri, United States, 63090
United States, New Mexico

Albequerque, New Mexico, United States, 87113
United States, New York

New York, New York, United States, 10021
United States, Tennessee

Goodlettsville, Tennessee, United States, 37072
United States, Texas

Austin, Texas, United States, 78731

Houston, Texas, United States, 77024

San Antonio, Texas, United States, 78229
United States, Utah

Salt Lake City, Utah, United States, 84132
Netherlands

Zwolle, Netherlands

Sponsors and Collaborators

Omeros Corporation

Investigators

Study Director:

Steve Whitaker, MD

Omeros Corporation

More Information

No publications provided

Responsible Party:	Omeros Corporation
ClinicalTrials.gov Identifier:	NCT01579565 History of Changes
Other Study ID Numbers:	OMS302-ILR-004
Study First Received:	April 13, 2012
Last Updated:	May 6, 2013
Health Authority:	United States: Food and Drug Administration United States: Institutional Review Board Netherlands: Medical Ethics Review Committee (METC) Netherlands: The Central Committee on Research Involving Human Subjects (CCMO) Austria: Ethikkommission Austria: Federal Office for Safety in Health Care

Keywords provided by Omeros Corporation:

cataract
lens replacement

ClinicalTrials.gov processed this record on June 18, 2013

Safety, Efficacy and Pharmacokinetics of OMS302 in Subjects Undergoing Intraocular Lens Replacement With Phacoemulsification (OMS302-ILR-004)