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

NCT03331770 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 103

Last updated 2017-11-08

No results posted yet for this study

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.

Conditions

  • Primary Open-angle Glaucoma

Interventions

DRUG

Latanoprost 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 & Collaborators

  • Laboratorios Poen

    lead INDUSTRY

Principal Investigators

  • Alejo Peyret, PhD · Hospital Durand, Argentina

  • Javier Casiraghi, PhD · Hospital de Clínicas "Jose de San Martin"

  • Daniel Grigera, PhD · Hospital Santa Lucia

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-01-06
Primary Completion
2017-10-06
Completion
2017-10-06

Countries

  • Argentina

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03331770 on ClinicalTrials.gov