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

• Sponsor: Bucci Laser Vision Institute (Other)
• Overall Status: Completed
• CT.gov ID: NCT01296542
• Collaborator: (none)
• Enrollment: 60
• Location: 1
• Arms: 2
• Duration (Months): 20.1
• Patients Per Site Per Month: 3

Study Details

Study Description

Brief Summary

To compare antibacterial efficacy of Besivance versus VIGAMOX for decreasing bacteria of the conjunctiva and lid margins in cataract patients prior to surgery after both 1 hour and 3 days of treatment.

Condition or Disease	Intervention/Treatment	Phase
Cataracts	Drug: Moxifloxacin Ophthalmic; Drug: Besifloxacin Ophthalmic	Phase 4

Study Design

• Study Type: Interventional
• Actual Enrollment: 60 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Comparison of Prophylactic Antibacterial Efficacy of Besivance Versus VIGAMOX Administered for Three Days and One Hour Prior to Phacoemulsification
• Study Start Date: May 1, 2011
• Actual Primary Completion Date: Jan 1, 2013
• Actual Study Completion Date: Jan 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: VIGAMOX Subjects will self administer drops 4 times daily for 3 days and one drop prior to sample collection	Drug: Moxifloxacin Ophthalmic
Active Comparator: Besivance Subjects will self administer drops 4 times daily for 3 days and one drop prior to sample collection	Drug: Besifloxacin Ophthalmic

Outcome Measures

Primary Outcome Measures

1. Number of Subjects With a Change in Bacterial Colonization of Lid and Conjunctival Cultures After 3 Days [Following 3 days of antibiotic drops topically instilled]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Man or woman 18 years of age or older.

• Physically capable of instilling eye drop or have an appropriate person available to assist in administration of eye drops 4 times a day.

• Scheduled for phacoemulsification with intraocular lens (IOL) implantation for the treatment of cataract.

• Meet the American Society of Anesthesiology (ASA) physical status I, II, or III and be medically cleared for surgery.

• Willing to adhere to the prohibitions and restrictions specified in this protocol.

• Subjects must have signed an informed consent document indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study.

Exclusion Criteria:

• Known allergy or contraindication to the test article(s) or their components.

• Presence of any abnormality or significant illness in the eye that in the investigator's opinion could affect the subject's health or the study parameters.

• Presence of an active ocular infection (bacterial, viral or fungal), or positive history of ocular herpetic infection.

• History of any significant illness that could be expected to interfere with the study parameters. Any condition that, in the opinion of the investigator, would compromise the well-being of the subject or the study.

• Use of disallowed therapies (systemic or topical):

• Fluoroquinolone anti-infective agents (systemic or topical) within 1 week of Visit 1 or anytime after Visit 1 for the duration of the study.

• Use of contact lenses for one week prior to the study and for the duration of the study.

• Received an experimental drug or used an experimental medical device within 21 days before the planned start of treatment.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Bucci Laser Vision Institute	Wilkes-Barre	Pennsylvania	United States	18702

Sponsors and Collaborators

• Bucci Laser Vision Institute

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., Principal Investigator, Bucci Laser Vision Institute
• ClinicalTrials.gov Identifier: NCT01296542
• Other Study ID Numbers: 2011-BV-C
• First Posted: Feb 15, 2011
• Last Update Posted: Dec 8, 2020
• Last Verified: Dec 1, 2020

• Additional relevant MeSH terms: Cataract; Moxifloxacin; Besifloxacin

Study Results

Participant Flow

Arm/Group Title	VIGAMOX	Besivance
Arm/Group Description	Subjects will self administer drops 4 times daily for 3 days and one drop prior to sample collection	Subjects will self administer drops 4 times daily for 3 days and one drop prior to sample collection
Period Title: Overall Study
STARTED	30	30
COMPLETED	30	28
NOT COMPLETED	0	2

Baseline Characteristics

Arm/Group Title	VIGAMOX	Besivance	Total
Arm/Group Description	Subjects will self administer drops 4 times daily for 3 days and one drop prior to sample collection	Subjects will self administer drops 4 times daily for 3 days and one drop prior to sample collection	Total of all reporting groups
Overall Participants	30	30	60
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	3 10%	7 23.3%	10 16.7%
>=65 years	27 90%	23 76.7%	50 83.3%
Sex: Female, Male (Count of Participants)
Female	18 60%	16 53.3%	34 56.7%
Male	12 40%	14 46.7%	26 43.3%

Outcome Measures

1. Primary Outcome

Title	Number of Subjects With a Change in Bacterial Colonization of Lid and Conjunctival Cultures After 3 Days
Description	Lid and Conjunctival cultures will be taken to measure bacterial colonization.
Time Frame	Following 3 days of antibiotic drops topically instilled

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	VIGAMOX	Besivance
Arm/Group Description	Subjects will self administer drops 4 times daily for 3 days and one drop prior to sample collection	Subjects will self administer drops 4 times daily for 3 days and one drop prior to sample collection
Measure Participants	30	28
Count of Participants [Participants]	18 60%	28 93.3%

Adverse Events

Arm/Group Title	VIGAMOX		Besivance
Arm/Group Description	Subjects will self administer drops 4 times daily for 3 days and one drop prior to sample collection		Subjects will self administer drops 4 times daily for 3 days and one drop prior to sample collection
All Cause Mortality
	VIGAMOX		Besivance
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	VIGAMOX		Besivance
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/30 (0%)		0/28 (0%)
Other (Not Including Serious) Adverse Events
	VIGAMOX		Besivance
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/30 (0%)		0/28 (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.