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

Pilot Study on Bioavailability of Vigamox Administered as Drops vs. as Spray

Status

Withdrawn

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00565630

Enrollment

Registered

2007-11-30

Start date

2008-01-31

Completion date

2008-03-31

Last updated

2009-02-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cataract

Brief summary

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.

Detailed 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.

Interventions

DEVICEVigamox delivered via the device in spray form

Vigamox delivered 4 times, 1 hour prior to cataract surgery

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Masking

SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Patients scheduled for elective cataract surgery

Exclusion criteria

* Known allergy to quinolone compounds

Design outcomes

Primary

Measure	Time frame
Aqeous concentration of Vigamox	one month

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026