Efficacy and Safety of Bromfenac Ophtha… | Clinical Trial

Key information

Conditions

Cataract Surgery

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

ISTA Pharmaceuticals, Inc.

Irvine, California, 92618, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Male or female greater than or equal to 18 years of age, and scheduled for cataract surgery

Exclusion criteria

Active corneal pathology in either eye

Treatment and study plan

bromfenac ophthalmic solution

Drug

sterile opthalmic solution

Primary outcomes

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

Time frame: Day 15

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

Secondary outcomes

Number of Participants That Are Pain Free

Time frame: Day 1

Participant description of being pain free taken from patient questionnaire with multiple possible responses

Sponsors and collaborators

Lead sponsor

Bausch & Lomb Incorporated

Industry

Registry information

Important dates

Study start: 2007
Primary completion: 2008
First posted: Jan 4, 2008
Registry last updated: Feb 15, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed