Bioequivalence of Eye Drops and Spray Administration of Vigamox

Cataract Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00666042
• Other study ID #: Eye drops vs. spray
• Secondary ID: different admini
• Status: Completed
• Phase: N/A
• First received: April 22, 2008
• Last updated: January 18, 2012
• Start date: February 2009
• Est. completion date: May 2009

Study information

• Verified date: August 2009
• Source: Advanced Ophthalmic Pharma
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Ethics Commission
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: May 2009
• Est. primary completion date: April 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years and older

Eligibility

Inclusion Criteria:

• Patients scheduled for elective cataract surgery

Exclusion Criteria:

• Allergy to Vigamox

Study Design

Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor)

Related Conditions & MeSH terms

• Cataract

Intervention

Drug:
• Vigamox - administration in spray form
Vigamox will be administered in a spray form
• Vigamox eye drops
Vigamox eye drops

Locations

Country	Name	City	State
Israel	Dept. of Ophthalmology, TAMC	Tel Aviv

Sponsors (1)

Lead Sponsor	Collaborator
Advanced Ophthalmic Pharma

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Bioequivalency between the 2 ways of administration		4 months	No