NCT00565630

Brief Summary

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.

Trial Health

15
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
16

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2008

Shorter than P25 for not_applicable

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 28, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 30, 2007

Completed
1 month until next milestone

Study Start

First participant enrolled

January 1, 2008

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2008

Completed
Last Updated

February 25, 2009

Status Verified

November 1, 2007

First QC Date

November 28, 2007

Last Update Submit

February 24, 2009

Conditions

Cataract

Outcome Measures

Primary Outcomes (1)

  • Aqeous concentration of Vigamox

    one month

Study Arms (2)

1

EXPERIMENTAL

Vigamox via the experiemntal device

Device: Vigamox delivered via the device in spray form

2

ACTIVE COMPARATOR

Vigamox drops from the commercially available bottles

Device: Vigamox delivered via the device in spray form

Interventions

Vigamox delivered via the device in spray formDEVICE

Vigamox delivered 4 times, 1 hour prior to cataract surgery

12

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients scheduled for elective cataract surgery

You may not qualify if:

  • Known allergy to quinolone compounds

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Cataract

Condition Hierarchy (Ancestors)

Lens DiseasesEye Diseases

Study Officials

  • Adi Michaeli, MD

    Dept of Ophthalmology, TAMC, Tel Aviv, Israel

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

November 28, 2007

First Posted

November 30, 2007

Study Start

January 1, 2008

Study Completion

March 1, 2008

Last Updated

February 25, 2009

Record last verified: 2007-11