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

NCT ID: NCT00565630

Last Updated: 2009-02-25

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

WITHDRAWN

Clinical Phase

NA

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-01-31

Study Completion Date

2008-03-31

Brief Summary

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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

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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.

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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1

Vigamox via the experiemntal device

Group Type EXPERIMENTAL

Vigamox delivered via the device in spray form

Intervention Type DEVICE

Vigamox delivered 4 times, 1 hour prior to cataract surgery

2

Vigamox drops from the commercially available bottles

Group Type ACTIVE_COMPARATOR

Vigamox delivered via the device in spray form

Intervention Type DEVICE

Vigamox delivered 4 times, 1 hour prior to cataract surgery

Interventions

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Vigamox delivered via the device in spray form

Vigamox delivered 4 times, 1 hour prior to cataract surgery

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Patients scheduled for elective cataract surgery

Exclusion Criteria

* Known allergy to quinolone compounds
Minimum Eligible Age

18 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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Dept. of Ophthalmology, TAMC, Tel Aviv, Israel

Principal Investigators

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Adi Michaeli, MD

Role: PRINCIPAL_INVESTIGATOR

Dept of Ophthalmology, TAMC, Tel Aviv, Israel

Other Identifiers

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TAMC 06-306

Identifier Type: -

Identifier Source: secondary_id

Drops vs. spray administration

Identifier Type: -

Identifier Source: org_study_id

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