Title
Efficacy and Tolerability of an Innovative Formulation of BAK-free Latanoprost
Multicentric Study to Evaluate the Efficacy and Tolerability of an Innovative Formulation of Benzalkonium Chloride-free Latanoprost in Patients With Primary Open-Angle Glaucoma
Phase
Phase 4Lead Sponsor
Laboratorios PoenStudy Type
InterventionalStatus
Completed No Results PostedIndication/Condition
Primary Open-angle GlaucomaIntervention/Treatment
Latanoprost Ophthalmic ProductStudy Participants
103This 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.
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.
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
Patients with primary open-angle glaucoma who were using BAK-containing latanoprost ophthalmic solution for ≥ 6 months (baseline), switched to a new formulation of latanoprost ophthalmic product
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.
