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

This study has been withdrawn prior to enrollment.
(Replaced with ongoing study)
Sponsor:
Information provided by:
Advanced Ophthalmic Pharma
ClinicalTrials.gov Identifier:
NCT00565630
First received: November 28, 2007
Last updated: February 24, 2009
Last verified: November 2007

November 28, 2007
February 24, 2009
January 2008
Not Provided
Aqeous concentration of Vigamox [ Time Frame: one month ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00565630 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Using Device Delivering Ophthalmic Solution in a Spray Form Instead of Eye Drops
Pilot Study on Bioavailability of Vigamox Administered as Drops vs. as Spray

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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Cataract
Device: Vigamox delivered via the device in spray form
Vigamox delivered 4 times, 1 hour prior to cataract surgery
  • Experimental: 1
    Vigamox via the experiemntal device
    Intervention: Device: Vigamox delivered via the device in spray form
  • Active Comparator: 2
    Vigamox drops from the commercially available bottles
    Intervention: Device: Vigamox delivered via the device in spray form
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
16
March 2008
Not Provided

Inclusion Criteria:

  • Patients scheduled for elective cataract surgery

Exclusion Criteria:

  • Known allergy to quinolone compounds
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00565630
Drops vs. spray administration, TAMC 06-306
No
Principle Investigator: Dr. Adi Michaeli, Dept. of Ophthalmology, TAMC, Tel Aviv, Israel
Advanced Ophthalmic Pharma
Not Provided
Principal Investigator: Adi Michaeli, MD Dept of Ophthalmology, TAMC, Tel Aviv, Israel
Advanced Ophthalmic Pharma
November 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP