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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This study has been withdrawn prior to enrollment.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
History of Changes
  Purpose

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
Cataract
 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:

MedlinePlus related topics: Cataract
U.S. FDA Resources

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.

  Eligibility

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

Inclusion Criteria:

  • Patients scheduled for elective cataract surgery

Exclusion Criteria:

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

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

No publications provided

Responsible Party: Principle Investigator: Dr. Adi Michaeli, Dept. of Ophthalmology, TAMC, Tel Aviv, Israel
ClinicalTrials.gov 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

Additional relevant MeSH terms:
Cataract
Lens Diseases
Eye Diseases
Moxifloxacin
Norgestimate, ethinyl estradiol drug combination
Anti-Infective Agents
Therapeutic Uses
 Pharmacologic Actions
Contraceptives, Oral, Combined
Contraceptives, Oral
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 23, 2013