Trial Outcomes & Findings for A Comparison of Peak Aqueous Penetration of Acuvail (Ketorolac 0.45%), Xibrom (Bromfenac 0.09%), and Nevanac (Nepafenac 0.1%)in Patients Undergoing Phacoemulsification (NCT NCT01001806)

NCT ID: NCT01001806

Last Updated: 2011-10-03

Results Overview

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 126 participants
• Primary outcome timeframe: day 4 of treatment
• Results posted on: 2011-10-03

Participant Flow

Participant milestones

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

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Acuvail n=42 Participants Acuvail to be given preoperatively. One drop BID, 1 day pre op and day of surgery 3 doses prior to surgery	Xibrom n=42 Participants Xibrom to be given 1 drop BID the day before surgery and 3 doses the day of surgery prior to surgery	Nevanac n=42 Participants One day before surgery 1 drop BID, then 3 doses pre op day of surgery	Total n=126 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Age, Categorical Between 18 and 65 years	21 Participants n=5 Participants	18 Participants n=7 Participants	15 Participants n=5 Participants	54 Participants n=4 Participants
Age, Categorical >=65 years	21 Participants n=5 Participants	24 Participants n=7 Participants	27 Participants n=5 Participants	72 Participants n=4 Participants
Age Continuous	75 years STANDARD_DEVIATION 30 • n=5 Participants	72 years STANDARD_DEVIATION 31 • n=7 Participants	74 years STANDARD_DEVIATION 29 • n=5 Participants	74 years STANDARD_DEVIATION 29 • n=4 Participants
Sex: Female, Male Female	26 Participants n=5 Participants	26 Participants n=7 Participants	29 Participants n=5 Participants	81 Participants n=4 Participants
Sex: Female, Male Male	16 Participants n=5 Participants	16 Participants n=7 Participants	13 Participants n=5 Participants	45 Participants n=4 Participants
Region of Enrollment United States	42 participants n=5 Participants	42 participants n=7 Participants	42 participants n=5 Participants	126 participants n=4 Participants

PRIMARY outcome

Timeframe: day 4 of treatment

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

Outcome measures

Measure	Acuvail n=42 Participants Acuvail to be given preoperatively. One drop BID, 1 day pre op and day of surgery 3 doses prior to surgery	Xibrom n=42 Participants Xibrom to be given 1 drop BID the day before surgery and 3 doses the day of surgery prior to surgery	Nevanac n=42 Participants One day before surgery 1 drop BID, then 3 doses pre op day of surgery
Peak Aqueous Penetration	688.87 ng/ml Standard Deviation 749.6	67.64 ng/ml Standard Deviation 62.4	447.1 ng/ml Standard Deviation 225.7

Adverse Events

Acuvail

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Xibrom

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Nevanac

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Frank A. Bucci, Jr., MD

Bucci Laser Vision

Phone: 570-825-5949

Email: Buccivision@aol.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place