Bioequivalence of Eye Drops and Spray Administration of Vigamox

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00666042

Enrollment

Registered

2008-04-24

Start date

2009-02-28

Completion date

2009-05-31

Last updated

2012-01-19

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

Conditions

Cataract

Brief 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.

Interventions

DRUGVigamox - administration in spray form

Vigamox will be administered in a spray form

DRUGVigamox eye drops

Vigamox eye drops

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Masking

SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

21 Years to No maximum

Healthy volunteers

Inclusion criteria

* Patients scheduled for elective cataract surgery

Exclusion criteria

* Allergy to Vigamox

Design outcomes

Primary

Measure	Time frame
Bioequivalency between the 2 ways of administration	4 months

Countries

Israel

Outcome results

None listed

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