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

• Status: Completed
• Trial end date: 2017-10-06
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Laboratorios Poen
• Treatments: Benzalkonium Compounds; Latanoprost

Criteria

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.