Bioequivalence of Eye Drops and Spray Administration of Vigamox

Not Applicable

Completed

• Conditions: Cataract
• Interventions: Drug: Vigamox - administration in spray form; Drug: Vigamox eye drops

• Registration Number: NCT00666042
• Lead Sponsor: Advanced Ophthalmic Pharma

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2008-04-22
• Study First Submitted QC: 2008-04-23
• Study First Posted: 2008-04-24
• Study Start: 2009-02
• Primary Completion: 2009-04
• Study Completion: 2009-05
• Status Verified: 2009-08
• Last Update Submitted: 2012-01-18
• Last Update Posted: 2012-01-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 16

Inclusion Criteria

• Patients scheduled for elective cataract surgery

Exclusion Criteria

• Allergy to Vigamox

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
A	Vigamox - administration in spray form	Vigamox delivered as spray
B	Vigamox eye drops	Patients will receive the commercially available Vigamox drops

Primary Outcome Measures

Name	Time	Method
Bioequivalency between the 2 ways of administration	4 months

Trial Locations

Locations (1)

Dept. of Ophthalmology, TAMC; 🇮🇱 Tel Aviv, Israel