NCT00704418

Brief Summary

Efficacy and Safety of Bromfenac Ophthalmic Solution in Cataract Surgery

Trial Health

87
On Track

Trial Health Score

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

Enrollment
156

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Jun 2008

Geographic Reach
1 country

1 active site

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

June 1, 2008

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

June 20, 2008

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 24, 2008

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2009

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2009

Completed
1.2 years until next milestone

Results Posted

Study results publicly available

January 26, 2011

Completed
Last Updated

January 18, 2013

Status Verified

January 1, 2013

Enrollment Period

7 months

First QC Date

June 20, 2008

Results QC Date

November 15, 2010

Last Update Submit

January 11, 2013

Conditions

Cataract

Keywords

Cataract extractionintraocular lens implantation

Outcome Measures

Primary Outcomes (1)

  • Number of Participants With Summed Ocular Inflammation Score (SOIS) of Zero

    Participants with SOIS of 0. Scale: 0=0 cells (complete absence); 0.5=1-5 cells; 1=6-15 cells (very slight); 2=16-25 cells (moderate); 3=26-50 cells (marked); 4=\>50 cells (intense)

    Day 15

Secondary Outcomes (1)

  • Number of Participants That Are Pain Free

    Day 1

Study Arms (2)

Bromfenac

EXPERIMENTAL

Bromfenac ophthalmic solution 0.09%, dosed 1 drop daily

Drug: Bromfenac

Placebo

PLACEBO COMPARATOR

Placebo, dosed 1 drop daily

Drug: Placebo

Interventions

BromfenacDRUG

sterile ophthalmic solution

Bromfenac
PlaceboDRUG

sterile ophthalmic solution

Placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Scheduled for cataract surgery

You may not qualify if:

  • Known hypersensitivity to bromfenac and salicylates

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

ISTA Pharmaceuticals, Inc.

Irvine, California, 92618, United States

Location

Related Publications (1)

  • Silverstein SM, Cable MG, Sadri E, Peace JH, Fong R, Chandler SP, Gow JA, Klier SM, McNamara TR; Bromfenac Ophthalmic Solution Once Daily (Bromday) Study Group. Once daily dosing of bromfenac ophthalmic solution 0.09% for postoperative ocular inflammation and pain. Curr Med Res Opin. 2011 Sep;27(9):1693-703. doi: 10.1185/03007995.2011.597663. Epub 2011 Jul 14.

    PMID: 21751945DERIVED

MeSH Terms

Conditions

Cataract

Interventions

bromfenac

Condition Hierarchy (Ancestors)

Lens DiseasesEye Diseases

Results Point of Contact

Title
Tim McNamara, Vice President, Clinical Research & Medical Affairs
Organization
ISTA Pharmaceuticals, Inc.
tmcnamara@istavision.com
949-788-6000

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 20, 2008

First Posted

June 24, 2008

Study Start

June 1, 2008

Primary Completion

January 1, 2009

Study Completion

December 1, 2009

Last Updated

January 18, 2013

Results First Posted

January 26, 2011

Record last verified: 2013-01

Locations

US(1)