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”

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

Primary Measures

• Bioequivalency between the 2 ways of administration
  • Time Frame: 4 months
    Safety Issue?: No

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

Lead Sponsor: Advanced Ophthalmic Pharma

Overall Clinical Trial Officials and Contacts

Adi Michaeli, MD Principal Investigator TAMC, Tel Aviv, Israel  

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