Trial Outcomes & Findings for A Comparison of Prophylactic Antibacterial Efficacy of Besivance vs. VIGAMOX Prior to Cataract Surgery (NCT NCT01296542)

NCT ID: NCT01296542

Last Updated: 2020-12-08

Results Overview

Lid and Conjunctival cultures will be taken to measure bacterial colonization.

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 60 participants
• Primary outcome timeframe: Following 3 days of antibiotic drops topically instilled
• Results posted on: 2020-12-08

Participant Flow

Participant milestones

Measure	VIGAMOX Subjects will self administer drops 4 times daily for 3 days and one drop prior to sample collection	Besivance Subjects will self administer drops 4 times daily for 3 days and one drop prior to sample collection
Overall Study STARTED	30	30
Overall Study COMPLETED	30	28
Overall Study NOT COMPLETED	0	2

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Comparison of Prophylactic Antibacterial Efficacy of Besivance vs. VIGAMOX Prior to Cataract Surgery

Baseline characteristics by cohort

Measure	VIGAMOX n=30 Participants Subjects will self administer drops 4 times daily for 3 days and one drop prior to sample collection	Besivance n=30 Participants Subjects will self administer drops 4 times daily for 3 days and one drop prior to sample collection	Total n=60 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	3 Participants n=5 Participants	7 Participants n=7 Participants	10 Participants n=5 Participants
Age, Categorical >=65 years	27 Participants n=5 Participants	23 Participants n=7 Participants	50 Participants n=5 Participants
Sex: Female, Male Female	18 Participants n=5 Participants	16 Participants n=7 Participants	34 Participants n=5 Participants
Sex: Female, Male Male	12 Participants n=5 Participants	14 Participants n=7 Participants	26 Participants n=5 Participants

PRIMARY outcome

Timeframe: Following 3 days of antibiotic drops topically instilled

Lid and Conjunctival cultures will be taken to measure bacterial colonization.

Outcome measures

Measure	VIGAMOX n=30 Participants Subjects will self administer drops 4 times daily for 3 days and one drop prior to sample collection	Besivance n=28 Participants Subjects will self administer drops 4 times daily for 3 days and one drop prior to sample collection
Number of Subjects With a Change in Bacterial Colonization of Lid and Conjunctival Cultures After 3 Days	18 Participants	28 Participants

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: buccivision@aol.com

Results disclosure agreements

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