A Comparison of Peak Aqueous Penetration of Acuvail (Ketorolac 0.45%), Xibrom (Bromfenac 0.09%), and Nevanac (Nepafenac 0.1%)in Patients Undergoing Phacoemulsification

• Sponsor: Frank A. Bucci, Jr., M.D. (Other)
• Overall Status: Completed
• CT.gov ID: NCT01001806
• Collaborator: Allergan (Industry)
• Enrollment: 126
• Location: 1
• Arms: 3
• Duration (Months): 3
• Patients Per Site Per Month: 41.7

Study Details

Study Description

Brief Summary

Approximately 126 subjects scheduled to undergo cataract surgery by phacoemulsification, will be randomized in an even allocation (1:1:1) to either Acuvail, Xibrom, or Nevanac. Subjects will be instructed to begin dosing the study medication in the operative eye the day before surgery and continue dosing on the day of surgery. Beginning one hour before surgery, 1 drop of study medication will be instilled by operating room staff approximately every 15 minutes for a total of 3 doses. At the designated time a paracentesis will be performed at the start of the cataract procedure and at least 0.15 cc of aqueous humor will be collected. The sample will be immediately stored on dry ice and shipped to a laboratory for analysis.

Condition or Disease	Intervention/Treatment	Phase
Cataracts	Drug: Ketorolac Tromethamine 0.45%; Drug: bromfenac 0.09%; Drug: nepafenac 0.1%	Phase 4

Study Design

• Study Type: Interventional
• Actual Enrollment: 126 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: A Comparison of Peak Aqueous Penetration of Acuvail, Xibrom, and Nevanac in Patients Undergoing Phacoemulsification
• Study Start Date: Oct 1, 2009
• Actual Primary Completion Date: Dec 1, 2009
• Actual Study Completion Date: Jan 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Acuvail Acuvail to be given preoperatively. One drop 2 times daily (BID), 1 day pre op and day of surgery 3 doses prior to surgery	Drug: Ketorolac Tromethamine 0.45%; One drop BID the day before surgery and then 3 doses the day of surgery prior to surgery; Other Names: Acuvail
Active Comparator: Xibrom Xibrom to be given 1 drop 2 times daily (BID) the day before surgery and 3 doses the day of surgery prior to surgery	Drug: bromfenac 0.09%; One day pre operative 1 drop BID then 3 doses pre op day of surgery; Other Names: Xibrom
Active Comparator: Nevanac One day before surgery 1 drop 2 times daily (BID), then 3 doses the day of surgery	Drug: nepafenac 0.1%; One drop BID, 1 day pre operative and then 3 doses the day of surgery; Other Names: Nevanac

Outcome Measures

Primary Outcome Measures

1. Peak Aqueous Penetration [day 4 of treatment]

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 eye 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 ophthalmic steroids, nonsteroidal anti-inflammatory (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

• Frank A. Bucci, Jr., M.D.
• Allergan

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Frank A. Bucci, Jr., M.D., Medical Director, Bucci Laser Vision Institute
• ClinicalTrials.gov Identifier: NCT01001806
• Other Study ID Numbers: 2009-0199
• First Posted: Oct 27, 2009
• Last Update Posted: Oct 3, 2011
• Last Verified: Aug 1, 2011

• Additional relevant MeSH terms: Cataract; Ketorolac; Ketorolac Tromethamine; Nepafenac; Bromfenac

Study Results

Participant Flow

Arm/Group Title	Acuvail	Xibrom	Nevanac
Arm/Group Description	Acuvail to be given preoperatively. One drop BID, 1 day pre op and day of surgery 3 doses prior to surgery	Xibrom to be given 1 drop BID the day before surgery and 3 doses the day of surgery prior to surgery	One day before surgery 1 drop BID, then 3 doses pre op day of surgery
Period Title: Overall Study
STARTED	42	42	42
COMPLETED	42	41	38
NOT COMPLETED	0	1	4

Baseline Characteristics

Arm/Group Title	Acuvail	Xibrom	Nevanac	Total
Arm/Group Description	Acuvail to be given preoperatively. One drop BID, 1 day pre op and day of surgery 3 doses prior to surgery	Xibrom to be given 1 drop BID the day before surgery and 3 doses the day of surgery prior to surgery	One day before surgery 1 drop BID, then 3 doses pre op day of surgery	Total of all reporting groups
Overall Participants	42	42	42	126
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%	0 0%
Between 18 and 65 years	21 50%	18 42.9%	15 35.7%	54 42.9%
>=65 years	21 50%	24 57.1%	27 64.3%	72 57.1%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	75 (30)	72 (31)	74 (29)	74 (29)
Sex: Female, Male (Count of Participants)
Female	26 61.9%	26 61.9%	29 69%	81 64.3%
Male	16 38.1%	16 38.1%	13 31%	45 35.7%
Region of Enrollment (participants) [Number]
United States	42 100%	42 100%	42 100%	126 100%

Outcome Measures

1. Primary Outcome

Title	Peak Aqueous Penetration
Time Frame	day 4 of treatment

Outcome Measure Data

Analysis Population Description

Protocol specified enrollment of 126 subjects and analysis was performed per protocol.

Arm/Group Title	Acuvail	Xibrom	Nevanac
Arm/Group Description	Acuvail to be given preoperatively. One drop BID, 1 day pre op and day of surgery 3 doses prior to surgery	Xibrom to be given 1 drop BID the day before surgery and 3 doses the day of surgery prior to surgery	One day before surgery 1 drop BID, then 3 doses pre op day of surgery
Measure Participants	42	42	42
Mean (Standard Deviation) [ng/ml]	688.87 (749.6)	67.64 (62.4)	447.1 (225.7)

Adverse Events

Arm/Group Title	Acuvail		Xibrom		Nevanac
Arm/Group Description	Acuvail to be given preoperatively. One drop BID, 1 day pre op and day of surgery 3 doses prior to surgery		Xibrom to be given 1 drop BID the day before surgery and 3 doses the day of surgery prior to surgery		One day before surgery 1 drop BID, then 3 doses pre op day of surgery
All Cause Mortality
	Acuvail		Xibrom		Nevanac
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)		/ (NaN)
Serious Adverse Events
	Acuvail		Xibrom		Nevanac
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/42 (0%)		0/42 (0%)		0/42 (0%)
Other (Not Including Serious) Adverse Events
	Acuvail		Xibrom		Nevanac
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/42 (0%)		0/42 (0%)		0/42 (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.