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NCT00565630 Clinical Trial

Using Device Delivering Ophthalmic Solution in a Spray Form Instead of Eye Drops

Cataract Clinical Trial

Official title:
Pilot Study on Bioavailability of Vigamox Administered as Drops vs. as Spray

Clinical Trial Details — Status: Withdrawn

Administrative data
NCT number NCT00565630
Other study ID # Drops vs. spray administration
Secondary ID TAMC 06-306
Status Withdrawn
Phase N/A
First received November 28, 2007
Last updated February 24, 2009
Start date January 2008
Est. completion date March 2008

Study information
Verified date November 2007
Source Advanced Ophthalmic Pharma
Contact n/a
Is FDA regulated No
Health authority Israel: Ethics Commission
Study type Interventional

Clinical Trial Summary

The purpose of the study is to confirm that Vigamox reaches similar aqueous concentration when administered as the commercially available eye drops or as a spray delivered from a proprietary device.

Description:

Patients scheduled for elective cataract surgery, will be randomly allocated to receive Vigamox 4 times , 1 hour prior to surgery, either via the experimental device in a spray form, or via the regular, commercially available bottle.

Aqueous sample will be collected and submitted to a masked laboratory for measuring Vigamox concentration.

Recruitment information / eligibility
Status Withdrawn
Enrollment 16
Est. completion date March 2008
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Patients scheduled for elective cataract surgery

Exclusion Criteria:

- Known allergy to quinolone compounds

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor)

Related Conditions & MeSH terms

Intervention

Device:
• Vigamox delivered via the device in spray form
Vigamox delivered 4 times, 1 hour prior to cataract surgery

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Advanced Ophthalmic Pharma

Outcome
Type Measure Description Time frame Safety issue
Primary Aqeous concentration of Vigamox one month No
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