Trial Outcomes & Findings for Aqueous Absorption and Pharmacokinetics of Besivance Versus VIGAMOX in Patients Undergoing Phacoemulsification (NCT NCT01296191)

Results Overview

Concentration of Besivance and VIGAMOX in the aqueous humor will be determined by an independent laboratory using standardized high-pressure liquid chromatography and mass spectrometry assays. Pharmacokinetic parameters determined from the aqueous humor concentration will minimally include the area under the curve and the maximum concentration.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

120 participants

Primary outcome timeframe

Measured after 3 days of drug instillation

Results posted on

2020-12-22

Participant Flow

Participant milestones

Participant milestones
Measure	VIGAMOX Subjects undergoing cataract surgery, randomized to the VIGAMOX group	Besivance Subjects scheduled for cataract surgery, randomized to the Besivance group
Overall Study STARTED	60	60
Overall Study COMPLETED	57	59
Overall Study NOT COMPLETED	3	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Aqueous Absorption and Pharmacokinetics of Besivance Versus VIGAMOX in Patients Undergoing Phacoemulsification

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	VIGAMOX n=60 Participants Subjects undergoing cataract surgery, randomized to the VIGAMOX group	Besivance n=60 Participants Subjects scheduled for cataract surgery, randomized to the Besivance group	Total n=120 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
Age, Categorical Between 18 and 65 years	9 Participants n=5 Participants	12 Participants n=7 Participants	21 Participants n=5 Participants
Age, Categorical >=65 years	51 Participants n=5 Participants	48 Participants n=7 Participants	99 Participants n=5 Participants
Sex: Female, Male Female	35 Participants n=5 Participants	28 Participants n=7 Participants	63 Participants n=5 Participants
Sex: Female, Male Male	25 Participants n=5 Participants	32 Participants n=7 Participants	57 Participants n=5 Participants

PRIMARY outcome

Timeframe: Measured after 3 days of drug instillation

Concentration of Besivance and VIGAMOX in the aqueous humor will be determined by an independent laboratory using standardized high-pressure liquid chromatography and mass spectrometry assays. Pharmacokinetic parameters determined from the aqueous humor concentration will minimally include the area under the curve and the maximum concentration.

Outcome measures

Outcome measures
Measure	VIGAMOX n=57 Participants Subjects undergoing cataract surgery, randomized to the VIGAMOX group	Besivance n=59 Participants Subjects scheduled for cataract surgery, randomized to the Besivance group
Pharmacokinetics in Aqueous Humor Samples.	443.07 ng/ml Standard Deviation 232.285	56.4525 ng/ml Standard Deviation 39.6325

Adverse Events

VIGAMOX

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Besivance

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