A Comparison of Post Phacoemulsification Aqueous Flare in Patients Using Ketorolac 0.45% 2 Times Daily (BID) and Bromfenac 0.09% 2 Times Daily (BID)

• Sponsor: Bucci Laser Vision Institute (Other)
• Overall Status: Completed
• CT.gov ID: NCT01023724
• Collaborator: Allergan (Industry)
• Enrollment: 50
• Location: 1
• Arms: 2
• Duration (Months): 2
• Patients Per Site Per Month: 24.5

Study Details

Study Description

Brief Summary

Approximately 50 patients undergoing cataract surgery will be randomized in an even allocation (1:1) into two treatment groups, either ketorolac 0.45% BID or bromfenac 0.09% BID. Patients will be instructed to begin dosing study medication in the operative eye the day before surgery and continue dosing until day 14. KOWA flare measurements will be performed at postoperative day one and postoperative day 14. The amount of anterior chamber inflammation (flare) will be objectively measured.

Condition or Disease	Intervention/Treatment	Phase
Post Operative Anterior Chamber Inflammation (Flare)	Drug: Ketorolac Tromethamine 0.45%; Drug: Bromfenac 0.09%	Phase 4

Study Design

• Study Type: Interventional
• Actual Enrollment: 50 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Comparison of Post Phacoemulsification Aqueous Flare in Patients Using Ketorolac 0.45% BID and Bromfenac 0.09% BID
• Study Start Date: Dec 1, 2009
• Actual Primary Completion Date: Jan 1, 2010
• Actual Study Completion Date: Feb 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: bromfenac 0.09% bromfenac 0.09% drops to be given pre operatively for one day BID, and then postoperatively for 14 days.	Drug: Bromfenac 0.09%; Drug given one drop BID for one day pre operatively and then BID for 14 days post operatively
Active Comparator: Acuvail Acuvail to be given preoperatively at BID for one day pre op and then post operatively for 14 days.	Drug: Ketorolac Tromethamine 0.45%; Acuvail to be given 1 drop BID for one day prior to surgery and then 1 drop BID post operatively for 14 days.

Outcome Measures

Primary Outcome Measures

1. Anterior Chamber Inflammation (Flare) [Day 14 of treatment]

   Anterior chamber flare measured by assessing the number of inflammatory cells in the anterior chamber.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Subjects must be 18 years of age or older

• Scheduled for cataract surgery by phacoemulsification

• Subject must be willing to comply with all study requirements and be willing to give informed consent

Exclusion Criteria:

• Any subject that has a history of uveitis or active iritis

• Subject can have no previous intraocular surgery with the exception of refractive surgery. but not within 6 months

• No ocular use of prostaglandins within 2 weeks of surgery

• Use of oral, injectable or topical steroids,nonsteroidal anti-inflammatory drugs (NSAIDs) or immunosuppressants within 14 days prior to surgery

• Contraindications to NSAIDs

• Active ocular infection

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Bucci Laser Vision Institute	Wilkes-Barre	Pennsylvania	United States	18702

Sponsors and Collaborators

• Bucci Laser Vision Institute
• Allergan

Investigators

• Principal Investigator: Frank A Bucci, Jr., MD, Bucci Laser Vision Institute

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT01023724
• Other Study ID Numbers: 2009-11-06 1
• First Posted: Dec 2, 2009
• Last Update Posted: Aug 26, 2011
• Last Verified: Jul 1, 2011

• Additional relevant MeSH terms: Inflammation; Ketorolac; Ketorolac Tromethamine; Bromfenac

Study Results

Participant Flow

Arm/Group Title	Xibrom	Acuvail
Arm/Group Description	Xibrom drops to be given pre operatively for one day BID, and then postoperatively for 14 days.	Acuvail to be given preoperatively at BID for one day pre op and then post operatively for 14 days.
Period Title: Overall Study
STARTED	25	25
COMPLETED	21	22
NOT COMPLETED	4	3

Baseline Characteristics

Arm/Group Title	Xibrom	Acuvail	Total
Arm/Group Description	Xibrom drops to be given pre operatively for one day BID, and then postoperatively for 14 days.	Acuvail to be given preoperatively at BID for one day pre op and then post operatively for 14 days.	Total of all reporting groups
Overall Participants	25	25	50
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	6 24%	7 28%	13 26%
>=65 years	19 76%	18 72%	37 74%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	70 (8)	72 (9)	71 (9)
Sex: Female, Male (Count of Participants)
Female	16 64%	18 72%	34 68%
Male	9 36%	7 28%	16 32%
Region of Enrollment (participants) [Number]
United States	25 100%	25 100%	50 100%

Outcome Measures

1. Primary Outcome

Title	Anterior Chamber Inflammation (Flare)
Description	Anterior chamber flare measured by assessing the number of inflammatory cells in the anterior chamber.
Time Frame	Day 14 of treatment

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Xibrom	Acuvail
Arm/Group Description	Xibrom drops to be given pre operatively for one day BID, and then postoperatively for 14 days.	Acuvail to be given preoperatively at BID for one day pre op and then post operatively for 14 days.
Measure Participants	25	25
Mean (Standard Deviation) [photon count per msec (pc/ms)]	24.48 (21.94)	21.93 (19.67)

Adverse Events

Arm/Group Title	Xibrom		Acuvail
Arm/Group Description	Xibrom drops to be given pre operatively for one day BID, and then postoperatively for 14 days.		Acuvail to be given preoperatively at BID for one day pre op and then post operatively for 14 days.
All Cause Mortality
	Xibrom		Acuvail
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Xibrom		Acuvail
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/25 (0%)		0/25 (0%)
Other (Not Including Serious) Adverse Events
	Xibrom		Acuvail
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/25 (0%)		0/25 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.