Using Device Delivering Ophthalmic Solution in a Spray Form Instead of Eye Drops
Information source: Advanced Ophthalmic Pharma
Information obtained from ClinicalTrials.gov on February 12, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Cataract
Intervention: Vigamox delivered via the device in spray form (Device)
Phase: N/A
Status: Not yet recruiting
Sponsored by: Advanced Ophthalmic Pharma Official(s) and/or principal investigator(s):
Adi Michaeli, MD, Principal Investigator, Affiliation: Dept of Ophthalmology, TAMC, Tel Aviv, Israel
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.
Clinical Details
Official title: Pilot Study on Bioavailability of Vigamox Administered as Drops vs. as Spray
Study design: Other, Randomized, Single Blind (Outcomes Assessor), Active Control, Parallel Assignment, Pharmacokinetics/Dynamics Study
Primary outcome: Aqeous concentration of Vigamox
Detailed 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.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Patients scheduled for elective cataract surgery
Exclusion Criteria:
- Known allergy to quinolone compounds
Locations and Contacts
Department of Ophthalmology, TAMC, Tel Aviv, Israel
Additional Information
Starting date: January 2008
Ending date: March 2008
Last updated: November 29, 2007
|
