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CompletedNCT00666042Updated Jan 19, 2012

Bioequivalence of Eye Drops and Spray Administration of Vigamox

An interventional study of Vigamox - administration in spray form and Vigamox eye drops in Cataract, sponsored by Advanced Ophthalmic Pharma. Completed at 1 site in Israel. Open to participants aged 21 Years and older. Per ClinicalTrials.gov, last updated 2012-01-19.

Sponsored by Advanced Ophthalmic Pharma · Not applicable and Interventional

Phase
Not applicable
Study type
Interventional
Enrollment
16
Allocation
Randomized
Ages
21 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Cataract

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03

In context

Cataract

1,701 studies on the registry are indexed under Cataract; 230 are open to participants now.

This study's planned enrollment of 16 is below the median of 80 across 1,155 interventional studies indexed under Cataract.

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Lead sponsor

Advanced Ophthalmic Pharma is the lead sponsor of 2 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
21 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Patients scheduled for elective cataract surgery

Exclusion criteria

Exclusion Criteria:

  • Allergy to Vigamox
05

Study design

Phase
Not applicable
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
16 participants (estimated)

Study arms

  • Experimental
    A

    Vigamox delivered as spray

    Drug: Vigamox - administration in spray form

  • Active comparator
    B

    Patients will receive the commercially available Vigamox drops

    Drug: Vigamox eye drops

Interventions

  • DrugVigamox - administration in spray form

    Vigamox will be administered in a spray form

  • DrugVigamox eye drops

    Vigamox eye drops

06

What researchers measure

Primary outcomes

  1. Bioequivalency between the 2 ways of administration

    Time frame: 4 months

07

Study locations

1 site
  • Dept. of Ophthalmology, TAMC
    Tel Aviv, 69089, Israel
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 19, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00666042
Lead sponsor
Advanced Ophthalmic Pharma
First posted
Apr 24, 2008
Start date
Feb 2009
Primary completion
Apr 2009
Completion
May 2009
Last update
Jan 19, 2012

Study contacts

Adi Michaeli, MD
principal investigator · TAMC, Tel Aviv, Israel

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2009. You cannot join it, but the record below documents what was studied.

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