Study of Ocular Penetration of Topically Administered Fluoroquinolones

NCT00924729 | Completed Phase 4 Results

• 1 other identifier: NA_28692
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Cataract Extraction

Outcome Measures

Primary Outcomes (1)

• Aqueous Humor Concentration of Study Drug

  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.

  approximately 3 to 4 months

Secondary Outcomes (1)

• Disk Diffusion Assay of Collected Aqueous Humor

  Approximately 3-4 months.

Study Arms (2)

Moxifloxacin 0.5% ophthalmic solution

ACTIVE COMPARATOR

Drug: Moxifloxacin 0.5% ophthalmic solution

Besifloxacin 0.6% ophthalmic suspension

ACTIVE COMPARATOR

Drug: Besifloxacin 0.6% ophthalmic suspension

Interventions

Moxifloxacin 0.5% ophthalmic solution DRUG

Administer moxifloxacin study drug prior to cataract surgery.

Also known as: Vigamox

Moxifloxacin 0.5% ophthalmic solution

Besifloxacin 0.6% ophthalmic suspension DRUG

Administer besifloxacin study drug prior to cataract surgery.

Also known as: Besivance

Besifloxacin 0.6% ophthalmic suspension

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Johns Hopkins University: lead

Study Sites (1)

The Wilmer Eye Institute at Johns Hopkins University

Baltimore, Maryland, 21287, United States

Location

MeSH Terms

Interventions

Moxifloxacin; Ophthalmic Solutions; besifloxacin

Intervention Hierarchy (Ancestors)

Fluoroquinolones; 4-Quinolones; Quinolones; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Pharmaceutical Solutions; Solutions; Pharmaceutical Preparations; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses; Specialty Uses of Chemicals

Results Point of Contact

• Title: Walter J. Stark, M.D./Professor of Ophthalmology
• Organization: Johns Hopkins University

wstark@jhmi.edu

410-955-5490

Study Officials

• Walter J. Stark, M.D.

  The Wilmer Eye Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 5, 2009
• First Posted: June 19, 2009
• Study Start: September 1, 2009
• Primary Completion: October 1, 2009
• Study Completion: November 1, 2009
• Last Updated: October 24, 2017
• Results First Posted: March 11, 2010

Record last verified: 2017-09

Locations

US (1)