NCT00666042

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
16

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2009

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 22, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 24, 2008

Completed
9 months until next milestone

Study Start

First participant enrolled

February 1, 2009

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2009

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2009

Completed
Last Updated

January 19, 2012

Status Verified

August 1, 2009

Enrollment Period

2 months

First QC Date

April 22, 2008

Last Update Submit

January 18, 2012

Conditions

Cataract

Outcome Measures

Primary Outcomes (1)

  • Bioequivalency between the 2 ways of administration

    4 months

Study Arms (2)

A

EXPERIMENTAL

Vigamox delivered as spray

Drug: Vigamox - administration in spray form

B

ACTIVE COMPARATOR

Patients will receive the commercially available Vigamox drops

Drug: Vigamox eye drops

Interventions

Vigamox - administration in spray formDRUG

Vigamox will be administered in a spray form

A
Vigamox eye dropsDRUG

Vigamox eye drops

B

Eligibility Criteria

Age21 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:

  • Allergy to Vigamox

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dept. of Ophthalmology, TAMC

Tel Aviv, 69089, Israel

Location

MeSH Terms

Conditions

Cataract

Condition Hierarchy (Ancestors)

Lens DiseasesEye Diseases

Study Officials

  • Adi Michaeli, MD

    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

April 22, 2008

First Posted

April 24, 2008

Study Start

February 1, 2009

Primary Completion

April 1, 2009

Study Completion

May 1, 2009

Last Updated

January 19, 2012

Record last verified: 2009-08

Locations

IL(1)