Bioequivalence of Eye Drops and Spray Administration of Vigamox

This study has been completed.
Sponsor:
Information provided by:
Advanced Ophthalmic Pharma
ClinicalTrials.gov Identifier:
NCT00666042
First received: April 22, 2008
Last updated: January 18, 2012
Last verified: August 2009
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 20, 2014