Tafluprost-Timolol Fixed Dose Combination Non-Inferiority Study Against Concomitant Administrations
NCT ID: NCT01306461
Last Updated: 2012-06-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
401 participants
INTERVENTIONAL
2011-03-31
2012-05-31
Brief Summary
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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
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Timolol and Tafluprost
Concomitant administration of preservative-free timolol and tafluprost eye drops
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
Fixed Dose Combination of tafluprost and timolol
Preservative-free Fixed Dose Combination of tafluprost and timolol eye drops
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
Interventions
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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
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
Eligibility Criteria
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Inclusion Criteria
* A diagnosis of ocular hypertension or open-angle glaucoma
* Meet specific IOP level at visit 1 (screening)and visit 2 (baseline)
* Meet specific visual acuity score
* Are willing to follow instructions
* Have provided a written informed consent
Exclusion Criteria
* IOP greater than 36 mmHg at any time point at screening or baseline
* Diagnosis of angle-closure glaucoma or secondary glaucoma other than capsular or pigmentary glaucoma in either eye
* Suspected contraindication or hypersensitivity to study medications tafluprost or timolol (e.g. asthma, low pulse) or to wash-out medication brinzolamide
* Glaucoma filtration surgery or any other ocular surgery (including ocular laser procedures) within 6 months prior to Screening
* Use of contact lenses at Screening or during the study
* Presence of any abnormality or significant illness that could be expected to interfere with the patient safety or study parameters
* Current participation in another clinical trial within the last 30 days
18 Years
ALL
No
Sponsors
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Santen Oy
INDUSTRY
Responsible Party
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Principal Investigators
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Auli Ropo, M.D.
Role: STUDY_DIRECTOR
Santen Oy
Clemens Vass, M.D.
Role: PRINCIPAL_INVESTIGATOR
Medical University Vienna, Austria
Marieta Kostianeva, M.D.
Role: PRINCIPAL_INVESTIGATOR
University Mulitiprofile Hospital for Active Treatment Sv.Georgi, Bulgaria
Eva Ruzickova, M.D.
Role: PRINCIPAL_INVESTIGATOR
Vseobecna fakultni nemocnice v Praze, Czech Republic
Gábor Holló
Role: PRINCIPAL_INVESTIGATOR
Semmelweis Egyetem, Hungary
Guna Laganovska, M.D.
Role: PRINCIPAL_INVESTIGATOR
P. Stradina Clinical University Hospital, Latvia
Maria L. Ribeiro, M.D.
Role: PRINCIPAL_INVESTIGATOR
Aibili-Associação p/ Investigação Biomédica e Inovação em Luz e Imagem (AIBILI), Portugal
Julián García-Feijóo, M.D.
Role: PRINCIPAL_INVESTIGATOR
Hospital Clinico San Carlos, Spain
Locations
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Debrecen, , Hungary
Countries
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Other Identifiers
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201051
Identifier Type: -
Identifier Source: org_study_id
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