MedTrace Logo

Tafluprost-Timolol Fixed Dose Combination Non-Inferiority Study Against Concomitant Administrations

NCT01306461 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 401

Last updated 2012-06-08

No results posted yet for this study

Summary

The purpose of this study is to compare the efficacy and safety of the preservative-free fixed-dose combination of tafluprost and timolol (FDC) to concomitant administration of tafluprost and timolol.

This study will enroll patients who have ocular hypertension or glaucoma.

The study schedule includes seven visits to the study site and three stages:

* washout of 5 days to 4 weeks depending on current glaucoma medication (if any)
* 6-month study treatment period
* 1-3 weeks post-study period

Conditions

Interventions

DRUG

Timolol and Tafluprost

Preservative-free Timolol eye drops administered twice daily concomitantly with preservative-free Tafluprost eye drops administered once daily Treatment period 6 months

DRUG

Fixed Dose Combination of tafluprost and timolol

Preservative-free Fixed Dose Combination of tafluprost and timolol eye drops administered once daily. For masking purposes also: vehicle for timolol administered twice daily Treatment period 6 months

Sponsors & Collaborators

  • Santen Oy

    lead INDUSTRY

Principal Investigators

  • Auli Ropo, M.D. · Santen Oy

  • Clemens Vass, M.D. · Medical University Vienna, Austria

  • Marieta Kostianeva, M.D. · University Mulitiprofile Hospital for Active Treatment Sv.Georgi, Bulgaria

  • Eva Ruzickova, M.D. · Vseobecna fakultni nemocnice v Praze, Czech Republic

  • Gábor Holló · Semmelweis Egyetem, Hungary

  • Guna Laganovska, M.D. · P. Stradina Clinical University Hospital, Latvia

  • Maria L. Ribeiro, M.D. · Aibili-Associação p/ Investigação Biomédica e Inovação em Luz e Imagem (AIBILI), Portugal

  • Julián García-Feijóo, M.D. · Hospital Clinico San Carlos, Spain

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-03-31
Primary Completion
2012-04-30
Completion
2012-05-31

Countries

  • Hungary

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 NCT01306461 on ClinicalTrials.gov