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This study has been withdrawn prior to enrollment.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)
Information provided by:
Advanced Ophthalmic Pharma Identifier:
First received: November 28, 2007
Last updated: February 24, 2009
Last verified: November 2007
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.

Condition Intervention
Device: Vigamox delivered via the device in spray form

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Official Title: Pilot Study on Bioavailability of Vigamox Administered as Drops vs. as Spray

Resource links provided by NLM:

Further study details as provided by Advanced Ophthalmic Pharma:

Primary Outcome Measures:
  • Aqeous concentration of Vigamox [ Time Frame: one month ] [ Designated as safety issue: No ]

Estimated Enrollment: 16
Study Start Date: January 2008
Estimated Study Completion Date: March 2008
Arms Assigned Interventions
Experimental: 1
Vigamox via the experiemntal device
Device: Vigamox delivered via the device in spray form
Vigamox delivered 4 times, 1 hour prior to cataract surgery
Active Comparator: 2
Vigamox drops from the commercially available bottles
Device: Vigamox delivered via the device in spray form
Vigamox delivered 4 times, 1 hour prior to cataract surgery

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.


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Patients scheduled for elective cataract surgery

Exclusion Criteria:

  • Known allergy to quinolone compounds
  Contacts and Locations
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Please refer to this study by its identifier: NCT00565630

Sponsors and Collaborators
Advanced Ophthalmic Pharma
Principal Investigator: Adi Michaeli, MD Dept of Ophthalmology, TAMC, Tel Aviv, Israel
  More Information

Responsible Party: Principle Investigator: Dr. Adi Michaeli, Dept. of Ophthalmology, TAMC, Tel Aviv, Israel Identifier: NCT00565630     History of Changes
Other Study ID Numbers: Drops vs. spray administration  TAMC 06-306 
Study First Received: November 28, 2007
Last Updated: February 24, 2009
Health Authority: Israel: Ethics Commission

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