Using Device Delivering Ophthalmic Solution in a Spray Form Instead of Eye Drops
Not Applicable
Withdrawn
- Conditions
- Cataract
- Interventions
- Device: Vigamox delivered via the device in spray form
- Registration Number
- NCT00565630
- Lead Sponsor
- Advanced Ophthalmic Pharma
- 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.
- 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.
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- 16
Inclusion Criteria
- Patients scheduled for elective cataract surgery
Exclusion Criteria
- Known allergy to quinolone compounds
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 1 Vigamox delivered via the device in spray form Vigamox via the experiemntal device 2 Vigamox delivered via the device in spray form Vigamox drops from the commercially available bottles
- Primary Outcome Measures
Name Time Method Aqeous concentration of Vigamox one month
- Secondary Outcome Measures
Name Time Method