drugset / Trial / NCT01280110

The Effects of BAK on the Blood Aqueous Barrier of Pseudophakic Patients

NCT01280110

RandomizedParallel-groupSingle-blindTreatment

Summary

BAK is one of the most frequent preservatives in eye drops. BAK is a quaternary ammonium salt with surfactant qualities. It can be bacteriostatic or bactericidal depending on the concentrations used. It has been shown to be effective against most bacteria with a few exceptions, such as Pseudomonas aeruginosa, or picornaviruses. It as been widely used in eyedrops, nose sprays, hand and face washes, mouthwashes, spermicidal creams, and in various other cleaners, sanitizers, and disinfectants. BAK gained popularity when it was first introduced because it also enhances corneal penetration of some drugs by causing epithelial separation. It is present in several ophthalmic formulations, including most of the antiglaucoma medications. If used chronically, BAK has been found to cause ocular surface changes, such as dry eye and punctuate keratitis. BAK has also been suggested to promote a break in the blood aqueous barrier, which may lead to undesirable consequences, such as uveitis and cystoid macular edema. However, this information is controversial. The purpose of this study is to evaluate the consequences of BAK on the blood-retinal and blood-aqueous barriers of pseudophakic patients receiving BAK-preserved lubricating drops.

Timeline

Start
2011-03
Primary completion
2011-12
Completion
2012-01

Drugs

EvaluationDrugModalityDoseRoute
Comparator Carboxymethylcellulose Other / unclassified Topical
Comparator hydroxypropylmethylcellulose Unknown Topical

Indications