Tafluprost-Timolol Preservative-free Fixed Dose Combination (FDC) Superiority Study Against Monotherapies
NCT ID: NCT01292460
Last Updated: 2013-03-13
Study Results
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Basic Information
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COMPLETED
PHASE3
600 participants
INTERVENTIONAL
2011-02-28
2012-09-30
Brief Summary
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The study medication period is 6 months, but the primary evaluation of efficacy is done at 3 months.
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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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Preservative-free timolol
Timolol/ FDC/ Placebo/ Tafluprost
Prior timolol users: Timolol (administered at 08:00 and 20:00) or FDC of tafluprost and timolol (at 08:00) and Placebo eye drops (at 20:00).
Prior prostaglandin users: Tafluprost (administered at 08:00) or FDC of tafluprost and timolol (administered at 08:00).
Preservative-free FDC and placebo
Timolol/ FDC/ Placebo/ Tafluprost
Prior timolol users: Timolol (administered at 08:00 and 20:00) or FDC of tafluprost and timolol (at 08:00) and Placebo eye drops (at 20:00).
Prior prostaglandin users: Tafluprost (administered at 08:00) or FDC of tafluprost and timolol (administered at 08:00).
Preservative-free tafluprost
Timolol/ FDC/ Placebo/ Tafluprost
Prior timolol users: Timolol (administered at 08:00 and 20:00) or FDC of tafluprost and timolol (at 08:00) and Placebo eye drops (at 20:00).
Prior prostaglandin users: Tafluprost (administered at 08:00) or FDC of tafluprost and timolol (administered at 08:00).
Preservative-free FDC
Timolol/ FDC/ Placebo/ Tafluprost
Prior timolol users: Timolol (administered at 08:00 and 20:00) or FDC of tafluprost and timolol (at 08:00) and Placebo eye drops (at 20:00).
Prior prostaglandin users: Tafluprost (administered at 08:00) or FDC of tafluprost and timolol (administered at 08:00).
Interventions
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Timolol/ FDC/ Placebo/ Tafluprost
Prior timolol users: Timolol (administered at 08:00 and 20:00) or FDC of tafluprost and timolol (at 08:00) and Placebo eye drops (at 20:00).
Prior prostaglandin users: Tafluprost (administered at 08:00) or FDC of tafluprost and timolol (administered at 08:00).
Eligibility Criteria
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Inclusion Criteria
* A diagnosis of ocular hypertension or open-angle glaucoma and prior use of timolol or prostaglandin.
* Meet specific IOP level at visit 1 (screening), visit 2 (run-in) and visit 3 (baseline).
* Meet specific visual acuity score
* Are willing to follow instructions
* Have provided a written informed consent
Exclusion Criteria
* IOP of 35 mmHg or greater
* 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
Hannu Uusitalo, M.D., Prof.
Role: PRINCIPAL_INVESTIGATOR
Tampere University
Locations
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Eye clinic, University Hospital of Kuopio
Kuopio, , Finland
Eye Clinic, University Hospital of Oulu
Oulu, , Finland
Countries
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References
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Pfeiffer N, Traverso CE, Lorenz K, Saarela V, Liinamaa J, Uusitalo H, Astakhov Y, Boiko E, Ropo A; Preservative-free Tafluprost/Timolol Fixed Combination Study Group. A 6-month study comparing efficacy, safety, and tolerability of the preservative-free fixed combination of tafluprost 0.0015% and timolol 0.5% versus each of its individual preservative-free components. Adv Ther. 2014 Dec;31(12):1228-46. doi: 10.1007/s12325-014-0163-3. Epub 2014 Dec 2.
Other Identifiers
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201050
Identifier Type: -
Identifier Source: org_study_id
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