Primary Open-angle Glaucoma
Conditions
Keywords
Benzalkonium Chloride, Latanoprost, BAK-free, Glaucoma, Ocular hypertension, conjunctival hyperemia, BUT, OSDI, Schirmer I, Corneal staining, Tear meniscus height
Brief summary
This study evaluates the efficacy and tolerability of a new formulation of latanoprost without Benzalkonium Chloride (BAK-free). Patients with open-angle glaucoma who were using BAK-containing latanoprost ophthalmic solution for ≥6 months, switched to BAK-free latanoprost ophthalmic emulsion.
Detailed description
Latanoprost is a prostaglandin F2alfa analogue that increases the uveoscleral outflow of aqueous humor, resulting in a intraocular pressure (IOP) reduction. Benzalkonium chloride (BAK) is usually employed in formulations of prostaglandin analogues due to its dual action of preservative and adjuvant in the formulation. However, this preservative has known toxic effects on the ocular surface, causing ocular dryness and discomfort on long-term use. Benzalkonium Chloride-free (BAK-free)Latanoprost is a new formulation approved for the use in patients with primary open angle glaucoma /ocular hypertension. In this study, patients that were using BAK-containing latanoprost for ≥6 months, switched to a new formulation of BAK-free latanoprost ophthalmic emulsion to evaluate its hypotensive action and quantify the changes in ocular surface parameters.
Interventions
DRUGLatanoprost Ophthalmic Product
Multidose bottle, preserved with potassium sorbate, that can be stored at room temperature up to 30°C during all shelf life, the emulsion does not require shaking before use
Sponsors
Laboratorios Poen
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
A prospective, open-label, single-arm, multicenter, 12-week study
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Men and women aged ≥ 18 years * Diagnosed with primary open-angle glaucoma or pseudoexfoliative glaucoma. * Receiving containing-BAK latanoprost as monotherapy for at least 6 months * Pachymetry between 520 and 580 microns * Informed consent given
Exclusion criteria
* History of allergic hypersensitivity or poor tolerance to latanoprost or any components of the formula * Angle closure glaucoma or secondary glaucoma * History of recent previous glaucoma surgery or trabeculoplasty (less than 1 year of surgery) * History of cataract surgery during the last 6 months * History of uveitis or intraocular inflammation * Corneal alteration * Pregnant patients, who wish to conceive or who are in the nursing period.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Intraocular pressure | At the baseline (still on treatment with BAK-containing latanoprost) | Intraocular pressure (IOP) is the fluid pressure inside the eye. Tonometry is the method eye care professionals use to determine it. IOP is an important aspect in the evaluation of patients at risk from glaucoma. Most tonometers measure pressure in millimeters of mercury (mmHg). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Conjunctival hyperemia | At the baseline (still on treatment with BAK-containing latanoprost) | Patients on treatment with prostaglandin analogues preserved with BAK suffer from conjunctival hyperemia. It is the most common side effect that leads to discontinuation or non-compliance. It is determined with the slit lamp. It is classified as patients without hyperemia or with mild, moderate, or severe hyperemia. |
| Schirmer I test | At the baseline (still on treatment with BAK-containing latanoprost) | Schirmer test measures the production of tears. This test consists of placing a small strip of filter paper inside the lower eyelid (inferior fornix). The eyes are closed for 5 minutes. The paper is then removed and the amount of moisture is measured (millimeter). |
| Ocular Surface Disease Index (OSDI) | At the baseline (still on treatment with BAK-containing latanoprost) | The OSDI score is a valid and reliable instrument for measuring dry eye disease severity (normal, mild to moderate, and sever) and effect on vision related function. It is determined using OSDI questionnaire (score). The OSDI score is assessed on a scale of 0 to 100, with higher scores representing greater disability. The index demonstrates sensitivity and specificity in distinguishing between normal patients and patients with dry eye disease. |
| Corneal epithelial fluorescein staining | At the baseline (still on treatment with BAK-containing latanoprost) | This is a test that uses orange dye (fluorescein) and a blue light to detect damage to the cornea. Fluorescein does not stain intact corneal epithelium but does stain corneal stroma, thus demarcating the area of the epithelial loss. Number of patients with corneal epithelial defects classified as inferior punctata keratitis or central corneal keratitis. |
| Tear meniscus height | At the baseline (still on treatment with BAK-containing latanoprost) | The height of the tear meniscus is related to the tear secretion rate and tear stability, and it is a good indicator of the overall tear volume. It is measured with a slit lamp and classified as normal, increased or decreased (millimeter). |
| Break up time (BUT) | At the baseline (still on treatment with BAK-containing latanoprost) | Tear film break-up time (TBUT) is a method for determining the stability of the tear film and checking evaporative dry eye. In testing for TBUT, sodium fluorescein dye is added to the eye and the tear film is observed under the slit lamp while the patient avoids blinking until tiny dry spots develop. The BUT is recorded as the number of seconds that elapse between the last blink and the appearance of the first dry spot in the tear film. |
Countries
Argentina
Outcome results
None listed