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

This study has been completed.
Sponsor:
Collaborator:
Merck
Information provided by (Responsible Party):
Vital Paulino Costa, University of Campinas, Brazil
ClinicalTrials.gov Identifier:
NCT01280110
First received: January 18, 2011
Last updated: July 12, 2012
Last verified: July 2012
History of Changes
  Purpose

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.


Condition Intervention Phase
Dry Eye Syndromes
 Drug: Hydroxypropylmethylcellulose
Drug: Carboxymethylcellulose
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Official Title: The Effects of BAK on the Blood Aqueous Barrier of Pseudophakic Patients

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Campinas, Brazil:

Primary Outcome Measures:
  • Aqueous Humor Flare [ Time Frame: Baseline, 15 days and 30 days. ] [ Designated as safety issue: Yes ]
    Aqueous humor flare indicates the degree of a break in the blood-aqueous barrier. It is objectively measured with a Laser flare meter.


Secondary Outcome Measures:
  • Macular Thickness [ Time Frame: Baseline, 15 days and 30 days. ] [ Designated as safety issue: Yes ]
    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.


Enrollment: 44
Study Start Date: March 2011
Study Completion Date: January 2012
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Preserved (BAK 0.006%) lubricating drop
One group will receive preserved lubricating drops 4 times a day for 1 month.
 Drug: Hydroxypropylmethylcellulose
22 patients will receive this lubricating drop 4 times a day for 1 month
Other Name: Retin Active
Active Comparator: Preservative-free lubricating drops
The second group will receive preservative-free lubricating drops 4 times a day for 1 month.
 Drug: Carboxymethylcellulose
22 patients will receive this lubricating drop 4 times a day for 1 month.
Other Name: Optive UD

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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01280110

Locations
Brazil
Department of Ophthalmology, University of Campinas
Campinas, SP, Brazil
Sponsors and Collaborators
University of Campinas, Brazil
Merck
Investigators
Principal Investigator: Vital P Costa, MD Department of Ophthalmology, University of Campinas
  More Information

Publications:

Responsible Party: Vital Paulino Costa, Professor of Ophthalmology, University of Campinas, Brazil
ClinicalTrials.gov Identifier: NCT01280110     History of Changes
Other Study ID Numbers: VPC1
Study First Received: January 18, 2011
Results First Received: June 7, 2012
Last Updated: July 12, 2012
Health Authority: Brazil: Ethics Committee

Keywords provided by University of Campinas, Brazil:
dry eye
pseudophakia
cornea
lubricating drop
 BAK
blood aqueous barrier
blood-retina barrier

Additional relevant MeSH terms:
Dry Eye Syndromes
Keratoconjunctivitis Sicca
Lacrimal Apparatus Diseases
Eye Diseases
Keratoconjunctivitis
Conjunctivitis
Conjunctival Diseases
 Keratitis
Corneal Diseases
Carboxymethylcellulose Sodium
Laxatives
Gastrointestinal Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 16, 2013