NCT01579565

Brief Summary

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
416

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Apr 2012

Shorter than P25 for phase_3

Geographic Reach
2 countries

14 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2012

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

April 13, 2012

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 18, 2012

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2012

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2013

Completed
1.6 years until next milestone

Results Posted

Study results publicly available

August 22, 2014

Completed
Last Updated

June 14, 2017

Status Verified

August 1, 2014

Enrollment Period

7 months

First QC Date

April 13, 2012

Results QC Date

July 2, 2014

Last Update Submit

May 19, 2017

Conditions

Intraocular Lens Replacement

Keywords

cataractlens replacement

Outcome Measures

Primary Outcomes (2)

  • Mean Area Under the Curve Analysis of Change-from-Baseline in Pupil Diameter (mm) During Surgery

    The co-primary analysis of the change in pupil diameter 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)

  • Mean Area Under the Curve Analysis of Ocular Pain VAS Score Within 12 Hours Postoperatively

    The co-primary analysis of the ocular pain VAS (where 0 = no pain and 100 = worst possible pain) based on the mean area under the curve (AUC). The AUC of the ocular pain VAS during 12 hours postoperatively was calculated by the trapezoidal rule in which the hour 11 was used to represent the time-point 10-12 hour. The mean AUC was defined as the AUC divided by the number of hours with ocular pain VAS results during the first 12 hours postoperatively.

    12 hours postoperatively

Secondary Outcomes (10)

  • Pupil Diameter Greater Than or Equal to 6 mm at Completion of Cortical Clean up

    at time of cortical clean-up (i.e., end of surgical procedure)

  • Pupil Diameter Less Than 6 mm Anytime During Surgery

    Intraoperative

  • Moderate-to-Severe Pain (VAS Greater Than or Equal to 40) at Any Time Point During 12 Hours Postoperatively

    12 hours postoperatively

  • Ocular Pain-Free (VAS Equal to 0) at All Time Points During 12 Hours Postoperatively

    12 hours postoperatively

  • Ocular Pain VAS Score on Day 1

    One day postoperatively

  • +5 more secondary outcomes

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

OMS302DRUG

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 saline salt (BSS) through a syringe filter. This will achieve 4.0 mL of the drug product in a 500 mL bottle of BSS.

OMS302
PlaceboDRUG

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

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (14)

Unknown Facility

Chandler, Arizona, 85224, United States

Location

Unknown Facility

Los Angeles, California, 90013, United States

Location

Unknown Facility

Fort Myers, Florida, 33901, United States

Location

Unknown Facility

Boston, Massachusetts, 02114, 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

Unknown Facility

Zwolle, Netherlands

Location

MeSH Terms

Conditions

Cataract

Condition Hierarchy (Ancestors)

Lens DiseasesEye 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

April 13, 2012

First Posted

April 18, 2012

Study Start

April 1, 2012

Primary Completion

November 1, 2012

Study Completion

January 1, 2013

Last Updated

June 14, 2017

Results First Posted

August 22, 2014

Record last verified: 2014-08

Locations

US(13)NL(1)