Trials Sponsors Conditions Drugs Pricing

Conditions

Cataract Postoperative Complications

Keywords

Cataract ExtractionAnti-Inflammatory Agents, Non-Steroidal

Outcome Measures

Primary Outcomes (1)

Ocular Inflammation Score
Cleared ocular inflammation in the study eye, defined as summed ocular inflammation score (SOIS) of 1 or less (anterior chamber cell score plus flare score, each measured on a 5-point scale) 0=none
Visit 4 (Day 15)

Secondary Outcomes (1)

Mean Ocular Inflammation Score
At each Visit 2 (Day3), Visit 3 (Day 8), Visit 4 (Day 15), Visit 5 (Day 22)

Study Arms (2)

Bromfenac

EXPERIMENTAL

Topical bromfenac ophthalmic solution 0.1%

Drug: Bromfenac

Placebo

PLACEBO COMPARATOR

Vehicle of bromfenac

Drug: Placebo

Interventions

BromfenacDrug

One drop in study eye every 12 hours for 14 days

Bromfenac

PlaceboDrug

One drop in study eye every 12 hours for 14 days

Placebo

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Cataract surgery
Summed ocular inflammation score (anterior chamber cell score plus flare score) of \>/= 3, 24 hours after the cataract extraction

Sponsors & Collaborators

Bausch & Lomb Incorporated
Industrylead

Study Sites (39)

Harold A Helms, MD

Birmingham, Alabama, 35205, United States

Eye Care Arkansas, PA

Little Rock, Arkansas, 72205, United States

UCI, Department of Ophthalmology

Irvine, California, 92697, United States

Anesthetic Eye Care Institute

Newport Beach, California, 92663, United States

Richard A Lewis, MD

Sacramento, California, 95819, United States

Eye Care of San Diego

San Diego, California, 92103, United States

Santa Clara Valley Medical Center

San Jose, California, 95128, United States

MeSH Terms

Conditions

Postoperative ComplicationsCataract

Interventions

bromfenac

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and SymptomsLens DiseasesEye Diseases

Study Officials

Lisa R Grillone, PhD
ISTA Pharmaceuticals, Inc.
STUDY DIRECTOR

Enrollment

527 participants (actual enrollment reported by the registry).

Study Design

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

Study Record Dates

First Submitted

September 12, 2005

First Posted

September 20, 2005

Study Start

May 2003

Date type not reported

This date has not been verified as actual or estimated.

Safety and Efficacy Study of Topical Bromfenac Versus Placebo to Treat Ocular Inflammation After Cataract Surgery

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

Primary Completion

Study Completion

First Submitted

First Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (1)

Study Arms (2)

Bromfenac

Placebo

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (39)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

Primary Completion

Study Completion

First Submitted

First Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (1)

Study Arms (2)

Bromfenac

Placebo

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (39)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations