Assessment of the Concentrations of Besifloxacin, Moxifloxacin, or Gatifloxacin in the Aqueous Humor of Subjects
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| ClinicalTrials.gov Identifier: NCT00824070 |
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Recruitment Status :
Completed
First Posted : January 16, 2009
Results First Posted : October 29, 2010
Last Update Posted : December 13, 2011
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Sponsor:
Bausch & Lomb Incorporated
Information provided by (Responsible Party):
Bausch & Lomb Incorporated
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Brief Summary:
This study is being conducted to assess the concentration of besifloxacin, moxifloxacin, or gatifloxacin in aqueous humor samples collected following topical instillation of the associated formulation in subjects undergoing cataract surgery.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Cataract Extraction | Drug: Besifloxacin hydrochloride Drug: moxifloxacin hydrochloride Drug: gatifloxacin | Phase 1 |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 105 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Screening |
| Official Title: | An Open-Label, Randomized Assessment of the Concentrations of Besifloxacin, Moxifloxacin, or Gatifloxacin in the Aqueous Humor of Subjects After a Single Topical Dose |
| Study Start Date : | February 2009 |
| Actual Primary Completion Date : | July 2009 |
| Actual Study Completion Date : | August 2009 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: Besifloxacin
Besifloxacin ophthalmic suspension
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Drug: Besifloxacin hydrochloride
Instill besifloxacin study medication in the study eye prior to making an incision for cataract extraction surgery.
Other Name: Besivance |
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Active Comparator: Moxifloxacin
Vigamox (moxifloxacin ophthalmic solution, 0.5%)
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Drug: moxifloxacin hydrochloride
Instill moxifloxacin study medication in the study eye prior to making an incision for cataract extraction surgery.
Other Name: Vigamox |
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Active Comparator: Gatifloxacin
Zymar (gatifloxacin ophthalmic solution, 0.3%)
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Drug: gatifloxacin
Instill gatifloxacin study medication in the study eye prior to making an incision for cataract extraction surgery.
Other Name: Zymar |
Primary Outcome Measures :
- The Aqueous Humor Drug Concentration. [ Time Frame: Visit 2, 1-14 days following screening visit ]An aqueous humor specimen was collected from the study eye for determination of drug concentration 60 min after study drug instillation.
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Subjects who are a candidate for a routine, uncomplicated, primary cataract extraction.
- Subjects who, in the Investigator's opinion, have potential for postoperative best corrected Snellen visual acuity of at least 20/200 in the study eye.
Exclusion Criteria:
- Subjects who have a known sensitivity, contraindication, or allergy to the study medication(s) or their components.
- Subjects who had any corneal refractive surgery in the study eye.
- Subjects who have a history or presence of chronic generalized systemic disease that the Investigator feels might increase the risk to the subject or confound the result of the study.
- Subjects who had ocular surgery in the study eye, including laser procedures, within the past 6 months.
- Subjects who have taken any topical ocular medication in the study eye, other than those required by the protocol and permitted for surgery, during the 24 hours prior to the study medication being instilled.
- Subjects who use any antibiotics (e.g., systemic or topical) within the 7 days prior to the surgery date.
- Subjects who are monocular.
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00824070
Locations
| United States, New York | |
| Ophthalmic Consultants of Long Island | |
| Rockville Center, New York, United States, 11570 | |
Sponsors and Collaborators
Bausch & Lomb Incorporated
Investigators
| Principal Investigator: | Eric Donnefeld | Ophthalmic Consultants of Long Island |
| Responsible Party: | Bausch & Lomb Incorporated |
| ClinicalTrials.gov Identifier: | NCT00824070 |
| Other Study ID Numbers: |
575 |
| First Posted: | January 16, 2009 Key Record Dates |
| Results First Posted: | October 29, 2010 |
| Last Update Posted: | December 13, 2011 |
| Last Verified: | December 2011 |
Keywords provided by Bausch & Lomb Incorporated:
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Bioavailability |
Additional relevant MeSH terms:
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Cataract Lens Diseases Eye Diseases Moxifloxacin Gatifloxacin Besifloxacin Norgestimate, ethinyl estradiol drug combination Anti-Bacterial Agents Anti-Infective Agents Topoisomerase II Inhibitors Topoisomerase Inhibitors Enzyme Inhibitors |
Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Contraceptive Agents, Hormonal Contraceptive Agents Reproductive Control Agents Physiological Effects of Drugs Contraceptives, Oral, Combined Contraceptives, Oral Contraceptive Agents, Female Ophthalmic Solutions Pharmaceutical Solutions |