Bioequivalence of Eye Drops and Spray Administration of Vigamox

Advanced Ophthalmic Pharma

Status: Completed

Conditions: Cataract

Treatments: Drug: Vigamox eye drops; Drug: Vigamox - administration in spray form

Study type: Interventional

Funder types: Industry

Identifiers

NCT00666042

different administrations

Eye drops vs. spray

Details and patient eligibility

About

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.

Enrollment: 16 estimated patients

Sex: All

Ages: 21+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients scheduled for elective cataract surgery

Exclusion criteria

• Allergy to Vigamox

Trial design

16 participants in 2 patient groups

A

Experimental group

Description:

Vigamox delivered as spray

Treatment:

Drug: Vigamox - administration in spray form

B

Active Comparator group

Description:

Patients will receive the commercially available Vigamox drops

Treatment:

Drug: Vigamox eye drops