Bioequivalence of Eye Drops and Spray Administration of Vigamox - Full Text View

Sponsor:	Advanced Ophthalmic Pharma
Information provided by:	Advanced Ophthalmic Pharma
ClinicalTrials.gov Identifier:	NCT00666042

Purpose

The study compares the amounts of Vigamox absorbed when administered as eye drops or in a spray form. Both administrations will be prior to patients undergoing elective cataract surgery and the aqueous samples will be analyzed by a laboratory in a masked fashion. The hypothesis is that there will be no difference between the 2 modes of administration.

Condition	Intervention
Cataract	Drug: Vigamox - administration in spray form Drug: Vigamox eye drops

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Bio-equivalence Study Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor)
Official Title:	Laboratory-masked, Randomized Parallel, Comparative, Pilot Study on the Bioavailability of Vigamox in the Aqueous Humor When Administered Either as Commercially Available Eye Drops or in a Spray Form

Resource links provided by NLM:

MedlinePlus related topics: Cataract

Drug Information available for: Tetrahydrozoline Moxifloxacin Moxifloxacin hydrochloride Tetrahydrozoline hydrochloride

U.S. FDA Resources

Further study details as provided by Advanced Ophthalmic Pharma:

Primary Outcome Measures:

Bioequivalency between the 2 ways of administration [ Time Frame: 4 months ] [ Designated as safety issue: No ]

Estimated Enrollment:	16
Study Start Date:	February 2009
Study Completion Date:	May 2009
Primary Completion Date:	April 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: A Vigamox delivered as spray	Drug: Vigamox - administration in spray form Vigamox will be administered in a spray form
Active Comparator: B Patients will receive the commercially available Vigamox drops	Drug: Vigamox eye drops Vigamox eye drops

Eligibility

Ages Eligible for Study:	21 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Patients scheduled for elective cataract surgery

Exclusion Criteria:

Allergy to Vigamox

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00666042

Locations

Israel
Dept. of Ophthalmology, TAMC
Tel Aviv, Israel, 69089

Sponsors and Collaborators

Advanced Ophthalmic Pharma

Investigators

Principal Investigator:

Adi Michaeli, MD

TAMC, Tel Aviv, Israel

More Information

No publications provided

Responsible Party:	Dr. Adi Michaeli/Principal Investigator, Tel Aviv Medical Center
ClinicalTrials.gov Identifier:	NCT00666042 History of Changes
Other Study ID Numbers:	Eye drops vs. spray, different administrations
Study First Received:	April 22, 2008
Last Updated:	January 18, 2012
Health Authority:	Israel: Ethics Commission

Additional relevant MeSH terms:

Cataract
Lens Diseases
Eye Diseases
Tetrahydrozoline
Moxifloxacin
Norgestimate, ethinyl estradiol drug combination
Nasal Decongestants
Vasoconstrictor Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions

Respiratory System Agents
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Infective Agents
Contraceptives, Oral, Combined
Contraceptives, Oral
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents

ClinicalTrials.gov processed this record on February 09, 2012