Trial Outcomes & Findings for A Comparison of Prostaglandin E2 (PGE2) Inhibition of Acuvail(Ketorolac 0.45%), Xibrom (Bromfenac 0.09%)and Nevanac (Nepafenac)in Patients Undergoing Phacoemulsification (NCT NCT01021761)

Last Updated: 2011-08-31

Results Overview

A spectroscopic quantification of PGE2 was performed on the aqueous humor samples collected with the results measured in pg/ml. PGE2 levels below 50 pg/ml were considered below the level of detection.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

126 participants

Primary outcome timeframe

Day 4 of treatment

Results posted on

2011-08-31

Participant Flow

Participant milestones

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

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Comparison of Prostaglandin E2 (PGE2) Inhibition of Acuvail(Ketorolac 0.45%), Xibrom (Bromfenac 0.09%)and Nevanac (Nepafenac)in Patients Undergoing Phacoemulsification

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Xibrom n=42 Participants Xibrom to be given 1 drop BID the day before surgery and 3 doses pre op the day of surgery prior to surgery	Nevanac n=42 Participants Nevanac to be given 1 drop BID the day before surgery and 3 doses pre op the day of surgery prior to surgery	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.	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	18 Participants n=5 Participants	15 Participants n=7 Participants	21 Participants n=5 Participants	54 Participants n=4 Participants
Age, Categorical >=65 years	24 Participants n=5 Participants	27 Participants n=7 Participants	21 Participants n=5 Participants	72 Participants n=4 Participants
Age Continuous	72 years STANDARD_DEVIATION 31 • n=5 Participants	74 years STANDARD_DEVIATION 29 • n=7 Participants	75 years STANDARD_DEVIATION 30 • n=5 Participants	74 years STANDARD_DEVIATION 29 • n=4 Participants
Sex: Female, Male Female	26 Participants n=5 Participants	29 Participants n=7 Participants	26 Participants n=5 Participants	81 Participants n=4 Participants
Sex: Female, Male Male	16 Participants n=5 Participants	13 Participants n=7 Participants	16 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 126 subjects to be enrolled and analysis was performed per protocol.

Outcome measures

Outcome measures
Measure	Xibrom n=42 Participants Xibrom to be given 1 drop BID the day before surgery and 3 doses pre op the day of surgery prior to surgery	Nevanac n=42 Participants Nevanac to be given 1 drop BID the day before surgery and 3 doses pre op the day of surgery prior to surgery	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.
Aqueous PGE2 Inhibition	288.7 pg/ml Standard Deviation 226.05	320.4 pg/ml Standard Deviation 205.6	224.8 pg/ml Standard Deviation 164.87

Adverse Events

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

Acuvail

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: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place