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| Name | Class |
|---|---|
| Vistakon Pharmaceuticals | INDUSTRY |
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Compare ocular tissue levels following topical ocular instillation of 1.5% levofloxacin ophthalmic solution or an active comparator in subjects undergoing cataract surgery.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental |
| |
| 2 | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 1.5% levofloxacin ophthalmic solution | Drug | Topical application |
| |
| 0.5% moxifloxacin hydrochloride ophthalmic solution |
| Measure | Description | Time Frame |
|---|---|---|
| Concentration of levofloxacin and active control in the aqueous humor | Time of surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse Events | 4 days |
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Inclusion Criteria:
Exclusion Criteria:
Known allergy or other contraindication to the test article(s) or their components.
Presence of any abnormality or significant illness in the eye that in the investigator's opinion could affect the subject's health or the study parameters.
History of or presence of any corneal pathology or disease
Presence of an active ocular infection (bacterial, viral or fungal), or positive history of ocular herpetic infection.
History of severe dry eye syndrome.
History or evidence of previous ocular surgery in the operative eye.
History of any significant illness that could be expected to interfere with the study parameters.
Use of disallowed therapies (systemic or topical):
Use of contact lenses in the 2 weeks prior to the study and for the duration of the study.
Received an experimental drug or used an experimental medical device within 30 days before the planned start of treatment.
Pregnant or breast-feeding.
Any condition that, in the opinion of the investigator, would compromise the well-being of the subject or the study.
Employees of the investigator or study center, with direct involvement in the proposed study or other studies under the direction of that investigator or study center, as well as family members of the employees or the investigator.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bucci Laser Vision & Ambulatory Surgery Center | Wilkes-Barre | Pennsylvania | 18702 | United States |
| Type | Date | Date Unknown |
|---|---|---|
| Release | Oct 29, 2009 | |
| Reset | Dec 1, 2009 | |
| Release | Jun 17, 2010 | |
| Reset | Jul 13, 2010 | |
| Release | Nov 7, 2011 | |
| Reset | Dec 7, 2011 | |
| Release | Apr 17, 2012 | |
| Reset | May 15, 2012 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Oct 29, 2009 | Dec 1, 2009 | |||
| Jun 17, 2010 |
| ID | Term |
|---|---|
| D002386 | Cataract |
| ID | Term |
|---|---|
| D007905 | Lens Diseases |
| D005128 | Eye Diseases |
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| Drug |
Topical application |
|
| Jul 13, 2010 |
| Nov 7, 2011 | Dec 7, 2011 |
| Apr 17, 2012 | May 15, 2012 |