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

February 24, 2009 updated by: Advanced Ophthalmic Pharma

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

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

16

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients scheduled for elective cataract surgery

Exclusion Criteria:

  • Known allergy to quinolone compounds

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Vigamox via the experiemntal device
Device: Vigamox delivered via the device in spray form
Vigamox delivered 4 times, 1 hour prior to cataract surgery
Active Comparator: 2
Vigamox drops from the commercially available bottles
Device: Vigamox delivered via the device in spray form
Vigamox delivered 4 times, 1 hour prior to cataract surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Aqeous concentration of Vigamox
Time Frame: one month
one month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Advanced Ophthalmic Pharma

Investigators

  • Principal Investigator: Adi Michaeli, MD, Dept of Ophthalmology, TAMC, Tel Aviv, Israel

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2008

Study Completion (Anticipated)

March 1, 2008

Study Registration Dates

First Submitted

November 28, 2007

First Submitted That Met QC Criteria

November 29, 2007

First Posted (Estimate)

November 30, 2007

Study Record Updates

Last Update Posted (Estimate)

February 25, 2009

Last Update Submitted That Met QC Criteria

February 24, 2009

Last Verified

November 1, 2007

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Drops vs. spray administration
  • TAMC 06-306

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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