Efficacy and Tolerability of an Innovative Formulation of BAK-free Latanoprost

Laboratorios Poen

Status and phase: Completed; Phase 4

Conditions: Primary Open-angle Glaucoma

Treatments: Drug: Latanoprost Ophthalmic Product

Study type: Interventional

Funder types: Industry

Identifiers

NCT03331770

SOLEMU03

Details and patient eligibility

About

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.

Full 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.

Enrollment: 103 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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103 participants in 1 patient group

BAK-free latanoprost ophthalmic emulsion

Experimental group

Description:

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

Treatment:

Drug: Latanoprost Ophthalmic Product