Using Device Delivering Ophthalmic Solution in a Spray Form Instead of Eye Drops

Advanced Ophthalmic Pharma

Status: Withdrawn

Conditions: Cataract

Treatments: Device: Vigamox delivered via the device in spray form

Study type: Interventional

Funder types: Industry

Identifiers

NCT00565630

Drops vs. spray administration

TAMC 06-306

Details and patient eligibility

About

The purpose of the study is to confirm that Vigamox reaches similar aqueous concentration when administered as the commercially available eye drops or as a spray delivered from a proprietary device.

Full description

Patients scheduled for elective cataract surgery, will be randomly allocated to receive Vigamox 4 times , 1 hour prior to surgery, either via the experimental device in a spray form, or via the regular, commercially available bottle.

Aqueous sample will be collected and submitted to a masked laboratory for measuring Vigamox concentration.

Enrollment: 16 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients scheduled for elective cataract surgery

Exclusion criteria

• Known allergy to quinolone compounds

Trial design

16 participants in 2 patient groups

1

Experimental group

Description:

Vigamox via the experiemntal device

Treatment:

Device: Vigamox delivered via the device in spray form

2

Active Comparator group

Description:

Vigamox drops from the commercially available bottles

Treatment:

Device: Vigamox delivered via the device in spray form