A Phase III, Randomized, Double-masked 6-month Trial to Compare the Efficacy and Safety of the Preservative-free Fixed-dose Combination of Tafluprost and Timolol Eye Drops to Those of Tafluprost and Timolol Eye Drops Given Concomitantly in Patients With Open Angle Glaucoma or Ocular Hypertension
Sponsor study identifier
interventional
401
1 country
1
Study Start
March 2011
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
April 2012
Actual (reported)Study Completion
May 2012
Actual (reported)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:
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
May 2012
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
February 28, 2011
Actual (reported)March 2011
Date type not reportedThis date has not been verified as actual or estimated.
March 1, 2011
Actual (reported)April 2012
Actual (reported)May 2012
Actual (reported)Change from baseline in the average diurnal intra-ocular pressure (IOP) at 6 months
6 months
Change from baseline in average diurnal IOP at 2 weeks, 6 weeks and 3 months
2 weeks, 6 weeks and 3 months
Change from baseline in timewise IOPs
2 weeks, 6 weeks, 3 months and 6 months
Concomitant administration of preservative-free timolol and tafluprost eye drops
Preservative-free Fixed Dose Combination of tafluprost and timolol eye drops
Preservative-free Timolol eye drops administered twice daily concomitantly with preservative-free Tafluprost eye drops administered once daily Treatment period 6 months
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
These entries preserve how the registry describes the intervention. Their treatment roles are shown separately from molecular identities.
Grouped treatment entry
Timolol and Tafluprost
The registry names several treatments. This does not confirm that participants received them together or that they form a single product.
View registry recordGrouped treatment entry
Fixed Dose Combination of tafluprost and timolol
The registry names several treatments. This does not confirm that participants received them together or that they form a single product.
View registry recordDebrecen, Hungary
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
401 participants (actual enrollment reported by the registry).
First Submitted
February 28, 2011
First Posted
March 1, 2011
Study Start
March 2011
Date type not reportedThis date has not been verified as actual or estimated.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
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
Primary Completion
April 2012
Actual (reported)Study Completion
May 2012
Actual (reported)Last Updated
June 8, 2012
Record last verified: 2012-06
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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