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

Information source: Advanced Ophthalmic Pharma
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Cataract

Intervention: Vigamox delivered via the device in spray form (Device)

Phase: N/A

Status: Withdrawn

Sponsored by: Advanced Ophthalmic Pharma

Official(s) and/or principal investigator(s):
Adi Michaeli, MD, Principal Investigator, Affiliation: Dept of Ophthalmology, TAMC, Tel Aviv, Israel


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.

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor)

Primary outcome: Aqeous concentration of Vigamox

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.


Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.


Inclusion Criteria:

- Patients scheduled for elective cataract surgery

Exclusion Criteria:

- Known allergy to quinolone compounds

Locations and Contacts

Additional Information

Starting date: January 2008
Last updated: February 24, 2009

Page last updated: August 23, 2015

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