Safety and Efficacy of OMS302 in Subjects Undergoing Intraocular Lens Replacement With Phacoemulsification

NCT01454063 | Completed Phase 3 Results

• 1 other identifier: OMS302 ILR 003
• Study Type: interventional
• Target: 405
• Locations: 1 country
• Sites: 16

Brief Summary

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

Conditions

Intraocular Lens Replacement

Keywords

cataract; lens replacement

Outcome Measures

Primary Outcomes (1)

• Mean Area-under-the-Curve (AUC) Analysis of Change From Baseline in Pupil Diameter (mm) During Surgery

  Change in pupil diameter over time from surgical baseline (immediately prior to surgical incision) to the end of the surgical procedure (wound closure) was summarized using descriptive statistics by treatment arm and time-point (every minute). The primary analysis of the change in pupil diameter was based on the mean area-under-the-curve (AUC) pupil diameter change from baseline. First, the AUC of the pupil diameter from surgical baseline to wound closure was calculated using the trapezoidal rule. Second, the mean AUC was obtained by dividing the AUC by the total time of surgery. Third, the mean AUC of change from baseline was calculated by subtracting the baseline pupil diameter from the mean AUC.

  from surgery baseline (pre-incision) through surgery end (time of cortical clean-up/wound closure)

Secondary Outcomes (6)

• Mean Area-under-the-Curve Analysis of Ocular Pain Visual Analog Scale (VAS) Score Within 12 Hours Postoperatively

  12 hours

• Photophobia at 6 Hours After Surgery (Ocular Pain and Symptoms Numerical Ordinal Scale [Numerical Rating System - NRS] Scores)

  Six hours postoperatively

• Photophobia at Day 1 After Surgery (Ocular Pain and Symptoms Numerical Ordinal Scale [Numerical Rating System - NRS] Scores)

  One day

• Best Corrected Visual Acuity (BVCA) Log Score on Day 1

  One day

• Ocular Inflammation in Summed Ocular Inflammation Score (SOIS) Grade on Day 1

  One day

Study Arms (2)

OMS302

EXPERIMENTAL

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

Drug: OMS302

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

OMS302 DRUG

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 millimolar (mM) phenylephrine hydrochloride (HCl) and 11.25 mM ketorolac tromethamine formulated in a 20 mM 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 balanced salt solution (BSS) through a syringe filter. This will achieve 4.0 mL of the drug product in a 500 mL bottle of BSS.

OMS302

Placebo DRUG

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 20 mM 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 through a syringe filter. This will achieve 4.0 mL of the drug product in a 500 mL bottle of BSS.

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Competent and willing to voluntarily provide informed consent
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Omeros Corporation: lead

Study Sites (16)

Unknown Facility

Chandler, Arizona, 85224, United States

Location

Unknown Facility

Glendale, Arizona, 85308, United States

Location

Unknown Facility

Los Angeles, California, 90013, United States

Location

Unknown Facility

Cape Coral, Florida, 33904, United States

Location

Unknown Facility

Fort Myers, Florida, 33901, United States

Location

Unknown Facility

Stuart, Florida, 34994, United States

Location

Unknown Facility

Bloomington, Minnesota, 55431, United States

Location

Unknown Facility

St Louis, Missouri, 63131, United States

Location

Unknown Facility

Washington, Missouri, 63090, United States

Location

Unknown Facility

Albuquerque, New Mexico, 87113, United States

Location

Unknown Facility

New York, New York, 10021, United States

Location

Unknown Facility

Goodlettsville, Tennessee, 37072, United States

Location

Unknown Facility

Austin, Texas, 78731, United States

Location

Unknown Facility

Houston, Texas, 77024, United States

Location

Unknown Facility

San Antonio, Texas, 78229, United States

Location

Unknown Facility

Salt Lake City, Utah, 84132, United States

Location

MeSH Terms

Conditions

Cataract

Condition Hierarchy (Ancestors)

Lens Diseases; Eye Diseases

Results Point of Contact

• Title: Chief Medical Officer
• Organization: Omeros Corporation

swhitaker@omeros.com

(206) 676-5000

Study Officials

• Steve Whitaker, MD

  Omeros Corporation

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 13, 2011
• First Posted: October 18, 2011
• Study Start: September 1, 2011
• Primary Completion: March 1, 2012
• Study Completion: March 1, 2012
• Last Updated: August 21, 2014
• Results First Posted: August 21, 2014

Record last verified: 2014-08

Locations

US (16)