Using Device Delivering Ophthalmic Solution in a Spray Form Instead of Eye Drops - Full Text View

Sponsored by:	Advanced Ophthalmic Pharma
Information provided by:	Advanced Ophthalmic Pharma
ClinicalTrials.gov Identifier:	NCT00565630

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

MedlinePlus related topics: Cataract

Drug Information available for: Moxifloxacin Moxifloxacin hydrochloride Tetrahydrozoline Tetrahydrozoline hydrochloride

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Randomized, Single Blind (Outcomes Assessor), Active Control, Parallel Assignment, Pharmacokinetics/Dynamics Study
Official Title:	Pilot Study on Bioavailability of Vigamox Administered as Drops vs. as Spray

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
1: Experimental Vigamox via the experiemntal device	Device: Vigamox delivered via the device in spray form Vigamox delivered 4 times, 1 hour prior to cataract surgery
2: Active Comparator 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

Locations

Israel
Department of Ophthalmology, TAMC
Tel Aviv, Israel

Sponsors and Collaborators

Advanced Ophthalmic Pharma

Investigators

Principal Investigator:

Adi Michaeli, MD

Dept of Ophthalmology, TAMC, Tel Aviv, Israel

More Information

Responsible Party:	Dept. of Ophthalmology, TAMC, Tel Aviv, Israel ( Principle Investigator: Dr. Adi Michaeli )
Study ID Numbers:	Drops vs. spray administration, TAMC 06-306
Study First Received:	November 28, 2007
Last Updated:	November 29, 2007
ClinicalTrials.gov Identifier:	NCT00565630
Health Authority:	Israel: Ethics Commission

Study placed in the following topic categories:

Moxifloxacin
Eye Diseases
Cataract
Lens Diseases
Tetrahydrozoline

ClinicalTrials.gov processed this record on January 15, 2009