Status:
COMPLETED
Efficacy and Tolerability of an Innovative Formulation of BAK-free Latanoprost
Lead Sponsor:
Laboratorios Poen
Conditions:
Primary Open-angle Glaucoma
Eligibility:
All Genders
18+ years
Phase:
PHASE4
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 latanop...
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 empl...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 6 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 6 2017
Estimated Enrollment :
103 Patients enrolled
Trial Details
Trial ID
NCT03331770
Start Date
January 6 2017
End Date
October 6 2017
Last Update
November 8 2017
Active Locations (1)
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1
Laboratoarios Poen
Buenos Aires, Argentina, 1407