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

Advanced Ophthalmic Pharma16 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Masking

SINGLE

Enrollment

Conditions

Cataract

Interventions

Vigamox delivered via the device in spray formDEVICE

Vigamox delivered 4 times, 1 hour prior to cataract surgery

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Patients scheduled for elective cataract surgery Exclusion Criteria: * Known allergy to quinolone compounds

Outcomes

Primary Outcomes

Aqeous concentration of Vigamox

Time frame: one month

Data from ClinicalTrials.gov

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