Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Merck Sharp & Dohme LLC | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Preserved (BAK 0.006%) lubricating drop | Active Comparator | One group will receive preserved lubricating drops 4 times a day for 1 month. |
|
| Preservative-free lubricating drops | Active Comparator | The second group will receive preservative-free lubricating drops 4 times a day for 1 month. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hydroxypropylmethylcellulose | Drug | 22 patients will receive this lubricating drop 4 times a day for 1 month |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Macular Thickness | 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. | Baseline, 15 days and 30 days. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Vital P Costa, MD | Department of Ophthalmology, University of Campinas | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Ophthalmology, University of Campinas | Campinas | São Paulo | Brazil |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20302969 | Background | 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. | |
| 15220734 | 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. |
Not provided
Not provided
Not provided
Recruitment period started on March 2011 through December 2011 in the Department of Ophthalmology at the Hospital das Clínicas - State University of Campinas.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Preserved (BAK 0.006%) Lubricating Drop | One group will receive preserved lubricating drops 4 times a day for 1 month. |
| FG001 | Preservative-free Lubricating Drops | The second group will receive preservative-free lubricating drops 4 times a day for 1 month. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Preserved (BAK 0.006%) Lubricating Drop | One group will receive preserved lubricating drops 4 times a day for 1 month. |
| BG001 | Preservative-free Lubricating Drops | The second group will receive preservative-free lubricating drops 4 times a day for 1 month. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Statiscal power of 80%. | Posted | Mean | Standard Deviation | photons/msec | Baseline, 15 days and 30 days. |
|
Not provided
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Preserved (BAK 0.006%) Lubricating Drop | One group will receive preserved lubricating drops 4 times a day for 1 month. |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Vital Paulino Costa | Departamento de Oftalmologia - Universidade Estadual de Campinas - Campinas - Brazil | 55-19-35217396 | vp.costa@uol.com.br |
Not provided
| ID | Term |
|---|---|
| D015352 | Dry Eye Syndromes |
| D019591 | Pseudophakia |
| D003316 | Corneal Diseases |
| ID | Term |
|---|---|
| D007766 | Lacrimal Apparatus Diseases |
| D005128 | Eye Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| D065347 | Hypromellose Derivatives |
| D002266 | Carboxymethylcellulose Sodium |
| ID | Term |
|---|---|
| D002482 | Cellulose |
| D005936 | Glucans |
| D001704 | Biopolymers |
| D011108 | Polymers |
| D046911 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Carboxymethylcellulose | Drug | 22 patients will receive this lubricating drop 4 times a day for 1 month. |
|
|
| 20931366 | 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. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
he second group will receive preservative-free lubricating drops 4 times a day for 1 month. The flare will be evaluated with Laser Flare Cell Meter (Kowa, FM 500, Japan). The patients will have 3 evaluations (baseline, 15 days and 30 days). The baseline measure is done before the use of the eyedrops.
|
|
| Secondary | Macular Thickness | 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. | Statiscal power of 80% | Posted | Mean | Standard Deviation | μm | Baseline, 15 days and 30 days. |
|
|
|
| 0 |
| 22 |
| 0 |
| 22 |
| EG001 | Preservative-free Lubricating Drops | The second group will receive preservative-free lubricating drops 4 times a day for 1 month. | 0 | 22 | 0 | 22 |
Not provided
Not provided
| Macromolecular Substances |
| D011134 | Polysaccharides |
| D002241 | Carbohydrates |
| D001697 | Biomedical and Dental Materials |
| D008420 | Manufactured Materials |
| D013676 | Technology, Industry, and Agriculture |
| D008747 | Methylcellulose |
| 30 days |
|