Study of Ocular Penetration of Topically Administered Fluoroquinolones
This study has been completed.
Sponsor:
Johns Hopkins University
Information provided by:
Johns Hopkins University
ClinicalTrials.gov Identifier:
NCT00924729
First received: June 5, 2009
Last updated: May 25, 2010
Last verified: November 2009
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Purpose
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 | Intervention | Phase |
|---|---|---|
|
Cataract Extraction |
Drug: Moxifloxacin 0.5% ophthalmic solution Drug: Besifloxacin 0.6% ophthalmic suspension |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Pharmacokinetics Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) |
| Official Title: | Parallel-group Study of Ocular Penetration of Peri-operative Topically Administered Fluoroquinolones With Cataract Surgery |
Resource links provided by NLM:
Further study details as provided by Johns Hopkins University:
Primary Outcome Measures:
- Aqueous Humor Concentration of Study Drug [ Time Frame: approximately 3 to 4 months ] [ Designated as safety issue: No ]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:
- Disk Diffusion Assay of Collected Aqueous Humor [ Time Frame: Approximately 3-4 months. ] [ Designated as safety issue: No ]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.
| Enrollment: | 50 |
| Study Start Date: | September 2009 |
| Study Completion Date: | November 2009 |
| Primary Completion Date: | October 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Active Comparator: Moxifloxacin 0.5% ophthalmic solution |
Drug: Moxifloxacin 0.5% ophthalmic solution
Administer moxifloxacin study drug prior to cataract surgery.
Other Name: Vigamox
|
| Active Comparator: Besifloxacin 0.6% ophthalmic suspension |
Drug: Besifloxacin 0.6% ophthalmic suspension
Administer besifloxacin study drug prior to cataract surgery.
Other Name: Besivance
|
Eligibility| Ages Eligible for Study: | 21 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00924729
Locations
| United States, Maryland | |
| 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 |
More Information
No publications provided
| Responsible Party: | Walter J. Stark, M.D./Professor of Ophthalmology, The Wilmer Eye Institute |
| ClinicalTrials.gov Identifier: | NCT00924729 History of Changes |
| Other Study ID Numbers: | NA_28692 |
| Study First Received: | June 5, 2009 |
| Results First Received: | February 24, 2010 |
| Last Updated: | May 25, 2010 |
| Health Authority: | United States: Institutional Review Board |
Additional relevant MeSH terms:
|
Eye Injuries, Penetrating Cataract Eye Injuries Facial Injuries Craniocerebral Trauma Wounds and Injuries Wounds, Penetrating Lens Diseases Eye Diseases Moxifloxacin Fluoroquinolones Norgestimate, ethinyl estradiol drug combination Anti-Infective Agents |
Therapeutic Uses Pharmacologic Actions Contraceptives, Oral, Combined Contraceptives, Oral Contraceptive Agents, Female Contraceptive Agents Reproductive Control Agents Physiological Effects of Drugs Anti-Bacterial Agents Nucleic Acid Synthesis Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on May 19, 2013