Bioequivalence of Eye Drops and Spray Administration of Vigamox

NCT ID: NCT00666042

Last Updated: 2012-01-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-02-28

Study Completion Date

2009-05-31

Brief Summary

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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.

Detailed Description

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Conditions

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Cataract

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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A

Vigamox delivered as spray

Group Type EXPERIMENTAL

Vigamox - administration in spray form

Intervention Type DRUG

Vigamox will be administered in a spray form

B

Patients will receive the commercially available Vigamox drops

Group Type ACTIVE_COMPARATOR

Vigamox eye drops

Intervention Type DRUG

Vigamox eye drops

Interventions

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Vigamox - administration in spray form

Vigamox will be administered in a spray form

Intervention Type DRUG

Vigamox eye drops

Vigamox eye drops

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Patients scheduled for elective cataract surgery

Exclusion Criteria

* Allergy to Vigamox
Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Advanced Ophthalmic Pharma

INDUSTRY

Sponsor Role lead

Responsible Party

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Tel Aviv Medical Center

Principal Investigators

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Adi Michaeli, MD

Role: PRINCIPAL_INVESTIGATOR

TAMC, Tel Aviv, Israel

Locations

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Dept. of Ophthalmology, TAMC

Tel Aviv, , Israel

Site Status

Countries

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Israel

Other Identifiers

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different administrations

Identifier Type: -

Identifier Source: secondary_id

Eye drops vs. spray

Identifier Type: -

Identifier Source: org_study_id

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