CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 44 enrolled
Drug / intervention
Hydroxypropylmethylcellulose +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01280110
NCT01280110Phase 4Completed

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

University of Campinas, Brazil·interventional·Posted Jan 20, 2011·Updated Jul 18, 2012

In Brief

A Phase 4 clinical trial evaluating Hydroxypropylmethylcellulose and Carboxymethylcellulose for Dry Eye Syndromes. Completed, enrolled 44 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesBrazil

Timeline

Phase 4CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedJan 20, 2011
Enrollment StartMar 1, 2011
Primary CompletionDec 1, 2011
Study CompletionJan 1, 2012
TodayJul 2, 2026
Enrollment to primary: 9 monthsPosted 15.5 years ago

Interventions

Hydroxypropylmethylcellulosedrug

22 patients will receive this lubricating drop 4 times a day for 1 month

Carboxymethylcellulosedrug

22 patients will receive this lubricating drop 4 times a day for 1 month.