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| Sponsor: | Santen Inc. |
|---|---|
| Collaborator: |
Vistakon Pharmaceuticals |
| Information provided by: | Santen Inc. |
| ClinicalTrials.gov Identifier: | NCT00630019 |
Purpose
Compare ocular tissue levels following topical ocular instillation of 1.5% levofloxacin ophthalmic solution or an active comparator in subjects undergoing cataract surgery.
| Condition | Intervention | Phase |
|---|---|---|
|
Cataract |
Drug: 1.5% levofloxacin ophthalmic solution Drug: 0.5% moxifloxacin hydrochloride ophthalmic solution |
Phase IV |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Pharmacokinetics Study Intervention Model: Parallel Assignment Masking: Single Blind (Investigator) Primary Purpose: Basic Science |
| Estimated Enrollment: | 96 |
| Study Start Date: | February 2008 |
| Primary Completion Date: | October 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: 1 |
Drug: 1.5% levofloxacin ophthalmic solution
Topical application
|
| Active Comparator: 2 |
Drug: 0.5% moxifloxacin hydrochloride ophthalmic solution
Topical application
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Use of disallowed therapies (systemic or topical):
Contacts and Locations
More Information
| Responsible Party: | Brian Schwam, MD, VISTAKON Pharmaceuticals |
| ClinicalTrials.gov Identifier: | NCT00630019 History of Changes |
| Other Study ID Numbers: | VPH0107 |
| Study First Received: | February 22, 2008 |
| Last Updated: | February 4, 2009 |
| Health Authority: | United States: Institutional Review Board |
|
Aqueous humor penetration by anti-infectives |
|
Cataract Lens Diseases Eye Diseases Ofloxacin Moxifloxacin Norgestimate, ethinyl estradiol drug combination Anti-Bacterial Agents Anti-Infective Agents Therapeutic Uses Pharmacologic Actions Nucleic Acid Synthesis Inhibitors |
Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Anti-Infective Agents, Urinary Renal Agents Contraceptives, Oral, Combined Contraceptives, Oral Contraceptive Agents, Female Contraceptive Agents Reproductive Control Agents Physiological Effects of Drugs |