Efficacy and Safety of Bromfenac Ophthalmic Solution

Cataract Surgery Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00585975
• Other study ID #: CL-S&E-0802071-P
• Status: Completed
• Phase: Phase 2
• First received: December 21, 2007
• Last updated: February 13, 2013
• Start date: October 2007

Study information

• Verified date: February 2013
• Source: Bausch & Lomb Incorporated
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

This is a safety and efficacy study of bromfenac ophthalmic solution

Recruitment information / eligibility

• Status: Completed
• Enrollment: 568
• Est. primary completion date: July 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cataract Surgery

Intervention

Drug:
• bromfenac ophthalmic solution
sterile opthalmic solution

Locations

Country	Name	City	State
United States	ISTA Pharmaceuticals, Inc.	Irvine	California

Sponsors (1)

Lead Sponsor	Collaborator
Bausch & Lomb Incorporated

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With Summed Ocular Inflammation Score (SOIS) of Zero	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)	Day 15	No
Secondary	Number of Participants That Are Pain Free	Participant description of being pain free taken from patient questionnaire with multiple possible responses	Day 1	No