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

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ClinicalTrials.gov Identifier: NCT00565630
Recruitment Status : Withdrawn (Replaced with ongoing study)
First Posted : November 30, 2007
Last Update Posted : February 25, 2009
Sponsor:
Information provided by:
Advanced Ophthalmic Pharma

Brief 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.

Condition or disease Intervention/treatment Phase
Cataract Device: Vigamox delivered via the device in spray form Not Applicable

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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 16 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Official Title: Pilot Study on Bioavailability of Vigamox Administered as Drops vs. as Spray
Study Start Date : January 2008
Estimated Study Completion Date : March 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cataract Eye Care
U.S. FDA Resources

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. Aqeous concentration of Vigamox [ Time Frame: one month ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients scheduled for elective cataract surgery

Exclusion Criteria:

  • Known allergy to quinolone compounds

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00565630


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

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
First Posted: November 30, 2007    Key Record Dates
Last Update Posted: February 25, 2009
Last Verified: November 2007

Additional relevant MeSH terms:
Cataract
Lens Diseases
Eye Diseases
Ophthalmic Solutions
Norgestimate, ethinyl estradiol drug combination
Moxifloxacin
Fluoroquinolones
Pharmaceutical Solutions
Contraceptives, Oral, Combined
Contraceptives, Oral
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs
Anti-Bacterial Agents
Anti-Infective Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Nucleic Acid Synthesis Inhibitors