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

NCT01280110 | Completed Phase 4 Results

• 1 other identifier: VPC1
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

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.

Conditions

Dry Eye Syndromes

Keywords

dry eye; pseudophakia; cornea; lubricating drop; BAK; blood aqueous barrier; blood-retina barrier

Outcome Measures

Primary Outcomes (1)

• Aqueous Humor Flare

  Aqueous humor flare indicates the degree of a break in the blood-aqueous barrier. It is objectively measured with a Laser flare meter.

  Baseline, 15 days and 30 days.

Secondary Outcomes (1)

• Macular Thickness

  Baseline, 15 days and 30 days.

Study Arms (2)

Preserved (BAK 0.006%) lubricating drop

ACTIVE COMPARATOR

One group will receive preserved lubricating drops 4 times a day for 1 month.

Drug: Hydroxypropylmethylcellulose

Preservative-free lubricating drops

ACTIVE COMPARATOR

The second group will receive preservative-free lubricating drops 4 times a day for 1 month.

Drug: Carboxymethylcellulose

Interventions

Hydroxypropylmethylcellulose DRUG

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

Also known as: Retin Active

Preserved (BAK 0.006%) lubricating drop

Carboxymethylcellulose DRUG

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

Also known as: Optive UD

Preservative-free lubricating drops

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Campinas, Brazil: lead
• Merck Sharp & Dohme LLC: collaborator

Study Sites (1)

Department of Ophthalmology, University of Campinas

Campinas, São Paulo, Brazil

Location

Related Publications (3)

• Baudouin C, Labbe A, Liang H, Pauly A, Brignole-Baudouin F. Preservatives in eyedrops: the good, the bad and the ugly. Prog Retin Eye Res. 2010 Jul;29(4):312-34. doi: 10.1016/j.preteyeres.2010.03.001. Epub 2010 Mar 17.

  PMID: 20302969 BACKGROUND

• Noecker RJ, Herrygers LA, Anwaruddin R. Corneal and conjunctival changes caused by commonly used glaucoma medications. Cornea. 2004 Jul;23(5):490-6. doi: 10.1097/01.ico.0000116526.57227.82.

  PMID: 15220734 BACKGROUND

• Ammar DA, Noecker RJ, Kahook MY. Effects of benzalkonium chloride-preserved, polyquad-preserved, and sofZia-preserved topical glaucoma medications on human ocular epithelial cells. Adv Ther. 2010 Nov;27(11):837-45. doi: 10.1007/s12325-010-0070-1. Epub 2010 Oct 7.

  PMID: 20931366 BACKGROUND

MeSH Terms

Conditions

Dry Eye Syndromes; Pseudophakia; Corneal Diseases

Interventions

Hypromellose Derivatives; Carboxymethylcellulose Sodium

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cellulose; Glucans; Biopolymers; Polymers; Macromolecular Substances; Polysaccharides; Carbohydrates; Biomedical and Dental Materials; Manufactured Materials; Technology, Industry, and Agriculture; Methylcellulose

Results Point of Contact

• Title: Vital Paulino Costa
• Organization: Departamento de Oftalmologia - Universidade Estadual de Campinas - Campinas - Brazil

vp.costa@uol.com.br

55-19-35217396

Study Officials

• Vital P Costa, MD

  Department of Ophthalmology, University of Campinas

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Ophthalmology

Study Record Dates

• First Submitted: January 18, 2011
• First Posted: January 20, 2011
• Study Start: March 1, 2011
• Primary Completion: December 1, 2011
• Study Completion: January 1, 2012
• Last Updated: July 18, 2012
• Results First Posted: July 12, 2012

Record last verified: 2012-07

Locations

BR (1)