Bioequivalence of Eye Drops and Spray Administration of Vigamox

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.

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Key information

Conditions

Cataract Eye Diseases Lens Diseases

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Dept. of Ophthalmology, TAMC

Tel Aviv, 69089, Israel

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Patients scheduled for elective cataract surgery

Exclusion criteria

Allergy to Vigamox

Treatment and study plan

Vigamox - administration in spray form

Drug

Vigamox will be administered in a spray form

Vigamox eye drops

Drug

Vigamox eye drops

Primary outcomes

Bioequivalency between the 2 ways of administration

Time frame: 4 months

Sponsors and collaborators

Lead sponsor

Advanced Ophthalmic Pharma

Industry

Registry information

Official study 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

Important dates

Study start: 2009
Primary completion: 2009
Study completion: 2009
First posted: Apr 24, 2008
Registry last updated: Jan 19, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed