Efficacy and Safety of Bromfenac Ophthalmic Solution in Cataract Surgery

Cataract Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00704418
• Other study ID #: CL-S&E-0415081-P-WR
• Status: Completed
• Phase: Phase 3
• First received: June 20, 2008
• Last updated: January 11, 2013
• Start date: June 2008
• Est. completion date: December 2009

Study information

• Verified date: January 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

Efficacy and Safety of Bromfenac Ophthalmic Solution in Cataract Surgery

Recruitment information / eligibility

• Status: Completed
• Enrollment: 156
• Est. completion date: December 2009
• Est. primary completion date: January 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Scheduled for cataract surgery

Exclusion Criteria:

• Known hypersensitivity to bromfenac and salicylates

Study Design

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

Related Conditions & MeSH terms

• Cataract

Intervention

Drug:
• Bromfenac
sterile ophthalmic solution
• Placebo
sterile ophthalmic 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 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	No
Secondary	Number of Participants That Are Pain Free	Participant description of being pain free (Score of none)taken from patient questionnaire, Ocular Comfort Grading Assessment with multiple possible responses	Day 1	No