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Efficacy of the Brand-name Latanoprost and One of Its Generic Version in Primary Open Angle Glaucoma and Ocular Hypertension

NCT02047630 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2017-07-25

No results posted yet for this study

Summary

The purpose of this study is to evaluate and compare efficacy and tolerability of the brand-name latanoprost and one of its generic version in subjects with primary open angle glaucoma or ocular hypertension.

This randomized, double-blinded, cross-over design study has a 4 months follow-up. There are two periods of 8 weeks. During the first period, subjects put brand-name latanoprost in one eye and the generic version in the other one. In the second period, drops are switched from one eye to the other. There are intraocular pressure measurements (diurnal curves) on day 0 (before treatment), at 8 weeks (at the end of first period) and at 16 weeks (at the end of second period). Variations of intraocular pressure in each eye will be evaluated.

Conditions

Interventions

DRUG

Generic latanoprost

DRUG

Brand-name latanoprost

Sponsors & Collaborators

  • CHU de Quebec-Universite Laval

    lead OTHER

Principal Investigators

  • Marie-Josée Fredette, MD, FRCSC · Centre de recherche du CHU de Québec; Université Laval

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-01-31
Primary Completion
2014-12-04
Completion
2014-12-04

Countries

  • Canada

Study Locations

More Related Trials

Entities

Diseases

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 NCT02047630 on ClinicalTrials.gov