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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01280110
Recruitment Status : Completed
First Posted : January 20, 2011
Results First Posted : July 12, 2012
Last Update Posted : July 18, 2012
Sponsor:
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Vital Paulino Costa, University of Campinas, Brazil

Tracking Information
First Submitted Date  ICMJE January 18, 2011
First Posted Date  ICMJE January 20, 2011
Results First Submitted Date  ICMJE June 7, 2012
Results First Posted Date  ICMJE July 12, 2012
Last Update Posted Date July 18, 2012
Study Start Date  ICMJE March 2011
Actual Primary Completion Date December 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 12, 2012)
Aqueous Humor Flare [ Time Frame: Baseline, 15 days and 30 days. ]
Aqueous humor flare indicates the degree of a break in the blood-aqueous barrier. It is objectively measured with a Laser flare meter.
Original Primary Outcome Measures  ICMJE
 (submitted: January 18, 2011)
Aqueous Humor Flare [ Time Frame: 1 month ]
Aqueous humor flare indicates the degree of a break in the blood-aqueous barrier. It is objectively measured with a Laser flare meter.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 12, 2012)
Macular Thickness [ Time Frame: Baseline, 15 days and 30 days. ]
Macular thickness will be measured with an Optical coherence tomography (OCT). Measures 5% under the normal population according to the OCT software will be considered break in the blood-retina barrier.
Original Secondary Outcome Measures  ICMJE
 (submitted: January 18, 2011)
Macular Thickness [ Time Frame: 1 month ]
Macular thickness is measured with an OCT and indicates a break in the blood-retina barrier.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Effects of BAK on the Blood Aqueous Barrier of Pseudophakic Patients
Official Title  ICMJE The Effects of BAK on the Blood Aqueous Barrier of Pseudophakic Patients
Brief 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.

Detailed Description

The primary hypothesis behind the study is that BAK may lead to a break in the blood-retina barrier in pseudophakic eyes, leading to an increase in macular thickness, compared to a non-BAK containing solution. The secondary hypothesis is that solutions containing BAK will increase the permeability of the blood aqueous barrier compared to non-BAK solutions. If the hypotheses are confirmed, they may serve as a contraindication to the use of BAK-preserved drops in pseudophakic eyes requiring chronic use of medications.

This is a prospective, randomized, examiner-masked, controlled study involving 44 pseudophakic eyes of 44 patients. Patients receiving any other eyedrop, with a previous history of uveitis, posterior capsule rupture or any other ophthalmic surgery will be excluded. Patients will be randomized to the use of a BAK-preserved lubricating drop or to the use of a non-preserved lubricating drop q.i.d for one month. Effects on the blood aqueous barrier will be objectively measured with a laser flare meter (Kowa, Japan) at baseline, 15 days and one month after inclusion. Patients will also have OCT images (Cirrus, Zeiss, USA) of the macula at the same time intervals to evaluate the possible effects on the blood-retina barrier. Macular thickness and the presence of cystoid macular edema will be evaluated at each time interval.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Condition  ICMJE Dry Eye Syndromes
Intervention  ICMJE
  • Drug: Hydroxypropylmethylcellulose
    22 patients will receive this lubricating drop 4 times a day for 1 month
    Other Name: Retin Active
  • Drug: Carboxymethylcellulose
    22 patients will receive this lubricating drop 4 times a day for 1 month.
    Other Name: Optive UD
Study Arms  ICMJE
  • Active Comparator: Preserved (BAK 0.006%) lubricating drop
    One group will receive preserved lubricating drops 4 times a day for 1 month.
    Intervention: Drug: Hydroxypropylmethylcellulose
  • Active Comparator: Preservative-free lubricating drops
    The second group will receive preservative-free lubricating drops 4 times a day for 1 month.
    Intervention: Drug: Carboxymethylcellulose
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 18, 2011)
44
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE January 2012
Actual Primary Completion Date December 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Pseudophakic eyes that underwent cataract surgery at least 6 months before.

Exclusion Criteria:

  • Use of any eyedrop.
  • Other conditions associated with a break in the blood-aqueous or blood retina barrier (ie diabetes, ARMD, vasculitis, uveitis)
  • Previous history of cystoid macular edema.
  • Previous ocular surgery other than cataract surgery.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Brazil
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01280110
Other Study ID Numbers  ICMJE VPC1
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Vital Paulino Costa, University of Campinas, Brazil
Study Sponsor  ICMJE University of Campinas, Brazil
Collaborators  ICMJE Merck Sharp & Dohme Corp.
Investigators  ICMJE
Principal Investigator: Vital P Costa, MD Department of Ophthalmology, University of Campinas
PRS Account University of Campinas, Brazil
Verification Date July 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP