NCT00333918

Brief Summary

The primary objective of this study is to investigate the efficacy and safety of bromfenac ophthalmic solution for treatment of ocular inflammation and pain in subjects who undergo cataract extraction and intraocular lens implantation.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
522

participants targeted

Target at P75+ for phase_3 pain

Timeline
Completed

Started Jun 2006

Shorter than P25 for phase_3 pain

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2006

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

June 4, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 6, 2006

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2007

Completed
Last Updated

February 15, 2013

Status Verified

February 1, 2013

Enrollment Period

9 months

First QC Date

June 4, 2006

Last Update Submit

February 13, 2013

Conditions

PainInflammation

Keywords

Cataract ExtractionAnti-Inflammatory Agents, Non-Steroidal

Outcome Measures

Primary Outcomes (1)

  • Reduction of ocular inflammation

Secondary Outcomes (1)

  • Secondary efficacy outcome for ocular pain will be the proportion of treated subjects that are pain free

Study Arms (2)

1-bromfenac ophthalmic solution

EXPERIMENTAL

sterile ophthalmic solution

Drug: bromfenac ophthalmic solution

2-placebo comparator

PLACEBO COMPARATOR

sterile ophthalmic solution

Drug: placebo comparator

Interventions

bromfenac ophthalmic solutionDRUG
1-bromfenac ophthalmic solution
placebo comparatorDRUG
2-placebo comparator

Eligibility Criteria

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

You may qualify if:

  • Scheduled for unilateral cataract surgery with no other ophthalmic surgical procedures planned during cataract surgery
  • Agree to return for all required visits
  • Agree to avoid disallowed medications

You may not qualify if:

  • Known hypersensitivity to bromfenac and salicylates

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Irvine, California, 92618, United States

Location

MeSH Terms

Conditions

PainInflammation

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsPathologic Processes

Study Officials

  • Ralph Bianca, PhD

    ISTA Pharmaceuticals, Inc.

    STUDY DIRECTOR

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 4, 2006

First Posted

June 6, 2006

Study Start

June 1, 2006

Primary Completion

March 1, 2007

Study Completion

March 1, 2007

Last Updated

February 15, 2013

Record last verified: 2013-02

Locations

US(1)