Study of Ocular Penetration of Topically Administered Fluoroquinolones

• Sponsor: Johns Hopkins University (Other)
• Overall Status: Completed
• CT.gov ID: NCT00924729
• Collaborator: (none)
• Enrollment: 50
• Location: 1
• Arms: 2
• Duration (Months): 2
• Patients Per Site Per Month: 24.9

Study Details

Study Description

Brief Summary

This study is being conducted to evaluate the intraocular penetration of Moxifloxacin 0.5% ophthalmic solution (Vigamox) and Besifloxacin 0.6% ophthalmic suspension (Besivance) after pre-operative topical administration in subjects undergoing cataract surgery.

Condition or Disease	Intervention/Treatment	Phase
Cataract Extraction	Drug: Moxifloxacin 0.5% ophthalmic solution; Drug: Besifloxacin 0.6% ophthalmic suspension	Phase 4

Study Design

• Study Type: Interventional
• Actual Enrollment: 50 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Other
• Official Title: Parallel-group Study of Ocular Penetration of Peri-operative Topically Administered Fluoroquinolones With Cataract Surgery
• Study Start Date: Sep 1, 2009
• Actual Primary Completion Date: Oct 1, 2009
• Actual Study Completion Date: Nov 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Moxifloxacin 0.5% ophthalmic solution	Drug: Moxifloxacin 0.5% ophthalmic solution; Administer moxifloxacin study drug prior to cataract surgery.; Other Names: Vigamox
Active Comparator: Besifloxacin 0.6% ophthalmic suspension	Drug: Besifloxacin 0.6% ophthalmic suspension; Administer besifloxacin study drug prior to cataract surgery.; Other Names: Besivance

Outcome Measures

Primary Outcome Measures

1. Aqueous Humor Concentration of Study Drug [approximately 3 to 4 months]

   Patients were randomly assigned to receive one drop of either moxifloxacin or besifloxacin every 10 minutes for a total of 4 doses, with the last dose given 30 minutes prior to the time of the cataract incision. The aqueous humor was corrected through the paracentesis site. The specimen was transferred immediately to a polypropylene tube and stored upright at ≤ 20° C. Moxifloxacin and besifloxacin concentrations in the aqueous humor were determined using a validated high performance liquid chromatography (HPLC)-tandem mass spectrometry method.

Secondary Outcome Measures

1. Disk Diffusion Assay of Collected Aqueous Humor [Approximately 3-4 months.]

   A disk diffusion assay was performed to determine the relative antimicrobial activity of the study drug in the aqueous humor. The reference organism used was a clinical isolate of S. epidermidis that will be grown and adjusted to a 0.5 MacFarland turbidity standard. The standardized suspension was inoculated onto a Mueller-Hinton II agar. A sample of the aqueous humor was applied to 6 mm sterile disks, dried, and then placed onto the inoculated Mueller-Hinton II agar plates. The plates were incubated for 24 hours at 35° C. The zone sizes were then recorded.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 21 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Subjects who have a visually significant cataract and are planning to have cataract surgery.

• Subjects who are willing/able and have signed informed consent approved by the Institutional Review Board.

Exclusion Criteria:

• Subjects who have a known hypersensitivity, allergy, or contraindication to any fluoroquinolone medication, in any form.

• Subjects who signs of ocular infection or active inflammation in the study eye.

• Subjects who have corneal pathology, including epithelial defect, corneal scarring, or severe dry eye syndrome.

• Subjects who have used any disallowed medication (including antibiotics) during the time period designated as described in the protocol.

• Subjects who have any active or chronic/recurrent ocular or systemic disease that is uncontrolled and is likely to increase the risk of infection to the patient or confound the results of the study.

• Subjects who are pregnant (or suspect to be pregnant) or nursing/lactating.

• Subjects who have participated in any study of an investigational drug or device within 30 days prior to enrollment.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	The Wilmer Eye Institute at Johns Hopkins University	Baltimore	Maryland	United States	21287

Sponsors and Collaborators

• Johns Hopkins University

Investigators

• Principal Investigator: Walter J. Stark, M.D., The Wilmer Eye Institute

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Johns Hopkins University
• ClinicalTrials.gov Identifier: NCT00924729
• Other Study ID Numbers: NA_28692
• First Posted: Jun 19, 2009
• Last Update Posted: Oct 24, 2017
• Last Verified: Sep 1, 2017

• Additional relevant MeSH terms: Eye Injuries, Penetrating; Cataract; Moxifloxacin; Besifloxacin; Ophthalmic Solutions

Study Results

Participant Flow

Arm/Group Title	Moxifloxacin 0.5% Ophthalmic Solution	Besifloxacin 0.6% Ophthalmic Suspension
Arm/Group Description	The patients in this group received one drop of moxifloxacin every 10 minutes for a total of 4 doses, with the last dose given 30+-2 minutes prior to the time of initiating the cataract incision.	The patients in this group received one drop of besifloxacin every 10 minutes for a total of 4 doses, with the last dose given 30+-2 minutes prior to the time of initiating the cataract incision.
Period Title: Overall Study
STARTED	25	25
COMPLETED	23	25
NOT COMPLETED	2	0

Baseline Characteristics

Arm/Group Title	Moxifloxacin 0.5% Ophthalmic Solution	Besifloxacin 0.6% Ophthalmic Suspension	Total
Arm/Group Description	The patients in this group received one drop of moxifloxacin every 10 minutes for a total of 4 doses, with the last dose given 30+-2 minutes prior to the time of initiating the cataract incision.	The patients in this group received one drop of besifloxacin every 10 minutes for a total of 4 doses, with the last dose given 30+-2 minutes prior to the time of initiating the cataract incision.	Total of all reporting groups
Overall Participants	25	25	50
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	3 12%	7 28%	10 20%
>=65 years	22 88%	18 72%	40 80%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	74.0 (8.90)	68.0 (14.0)	71.0 (12.0)
Sex: Female, Male (Count of Participants)
Female	11 44%	10 40%	21 42%
Male	14 56%	15 60%	29 58%
Region of Enrollment (participants) [Number]
United States	25 100%	25 100%	50 100%

Outcome Measures

1. Primary Outcome

Title	Aqueous Humor Concentration of Study Drug
Description	Patients were randomly assigned to receive one drop of either moxifloxacin or besifloxacin every 10 minutes for a total of 4 doses, with the last dose given 30 minutes prior to the time of the cataract incision. The aqueous humor was corrected through the paracentesis site. The specimen was transferred immediately to a polypropylene tube and stored upright at ≤ 20° C. Moxifloxacin and besifloxacin concentrations in the aqueous humor were determined using a validated high performance liquid chromatography (HPLC)-tandem mass spectrometry method.
Time Frame	approximately 3 to 4 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Moxifloxacin 0.5% Ophthalmic Solution	Besifloxacin 0.6% Ophthalmic Suspension
Arm/Group Description	The patients in this group received one drop of moxifloxacin every 10 minutes for a total of 4 doses, with the last dose given 30+-2 minutes prior to the time of initiating the cataract incision.	The patients in this group received one drop of besifloxacin every 10 minutes for a total of 4 doses, with the last dose given 30+-2 minutes prior to the time of initiating the cataract incision.
Measure Participants	23	25
Mean (Standard Deviation) [µg/ml]	1.6108 (0.6835)	0.0312 (0.0131)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Moxifloxacin 0.5% Ophthalmic Solution, Besifloxacin 0.6% Ophthalmic Suspension
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments
	Method	Wilcoxon (Mann-Whitney)
	Comments

2. Secondary Outcome

Title	Disk Diffusion Assay of Collected Aqueous Humor
Description	A disk diffusion assay was performed to determine the relative antimicrobial activity of the study drug in the aqueous humor. The reference organism used was a clinical isolate of S. epidermidis that will be grown and adjusted to a 0.5 MacFarland turbidity standard. The standardized suspension was inoculated onto a Mueller-Hinton II agar. A sample of the aqueous humor was applied to 6 mm sterile disks, dried, and then placed onto the inoculated Mueller-Hinton II agar plates. The plates were incubated for 24 hours at 35° C. The zone sizes were then recorded.
Time Frame	Approximately 3-4 months.

Outcome Measure Data

Analysis Population Description

The amount of aqueous concentration of antibiotic agent was not enough to perform a secondary analysis

Arm/Group Title	Moxifloxacin 0.5% Ophthalmic Solution	Besifloxacin 0.6% Ophthalmic Suspension
Arm/Group Description	Moxifloxacin 0.5% ophthalmic solution: Administer moxifloxacin study drug prior to cataract surgery.	Besifloxacin 0.6% ophthalmic suspension: Administer besifloxacin study drug prior to cataract surgery.
Measure Participants	0	0

Adverse Events

Arm/Group Title	Moxifloxacin 0.5% Ophthalmic Solution		Besifloxacin 0.6% Ophthalmic Suspension
Arm/Group Description	The patients in this group received one drop of moxifloxacin every 10 minutes for a total of 4 doses, with the last dose given 30+-2 minutes prior to the time of initiating the cataract incision.		The patients in this group received one drop of besifloxacin every 10 minutes for a total of 4 doses, with the last dose given 30+-2 minutes prior to the time of initiating the cataract incision.
All Cause Mortality
	Moxifloxacin 0.5% Ophthalmic Solution		Besifloxacin 0.6% Ophthalmic Suspension
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/25 (0%)		0/25 (0%)
Serious Adverse Events
	Moxifloxacin 0.5% Ophthalmic Solution		Besifloxacin 0.6% Ophthalmic Suspension
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/25 (0%)		0/25 (0%)
Other (Not Including Serious) Adverse Events
	Moxifloxacin 0.5% Ophthalmic Solution		Besifloxacin 0.6% Ophthalmic Suspension
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/25 (0%)		0/25 (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.