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...
Date First Received: April 22, 2008
Last Updated: February 24, 2009
Verified by: Advanced Ophthalmic Pharma, February 2009
Clinical Trial Phase: N/A | Start Date: February 2009
Overall Status: Recruiting
Estimated Enrollment: 16
Brief Summary
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”
Condition Keyword(s):
Intervention(s):
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.
Study Type: Interventional
Study Design: Other, Randomized, Single Blind (Outcomes Assessor), Active Control, Parallel Assignment, Bio-equivalence Study
Study Primary Completion Date: May 2009
Intervention(s) in this Clinical Trial
- Drug: Vigamox - administration in spray form
- Vigamox will be administered in a spray form
- Drug: Vigamox eye drops
- Vigamox eye drops
Arms, Groups and Cohorts in this Clinical Trial
- Experimental: A
- Vigamox delivered as spray
- Active Comparator: B
- Patients will receive the commercially available Vigamox drops
Outcome Measures for this Clinical Trial
Primary Measures
- Bioequivalency between the 2 ways of administration
- Time Frame: 4 months
Safety Issue?: No
- Time Frame: 4 months
Criteria for Participation in this Clinical Trial
Inclusion Criteria:
- Patients scheduled for elective cataract surgery
Exclusion Criteria:
- Allergy to Vigamox
Gender Eligibility for this Clinical Trial: Both
Minimum Age for this Clinical Trial: 21 Years
Maximum Age for this Clinical Trial: N/A
Are Healthy Volunteers Accepted for this Clinical Trial?: No
Clinical Trial Sponsor Information
Lead Sponsor: Advanced Ophthalmic Pharma
Overall Clinical Trial Officials and Contacts
Adi Michaeli, MD Principal Investigator TAMC, Tel Aviv, Israel
Additional Information
Information obtained from ClinicalTrials.gov on July 02, 2009
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00666042
Study ID Number: Eye drops vs. spray
ClinicalTrials.gov Identifier: NCT00666042
Health Authority: Israel: Ethics Commission
Clinical Trials Authorship and Review
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