Tafluprost-Timolol Preservative-free Fixed Dose Combination (FDC) Superiority Study Against Monotherapies

Phase 3

Completed

• Conditions: Ocular Hypertension; Open-angle Glaucoma
• Interventions: Drug: Timolol/ FDC/ Placebo/ Tafluprost

• Registration Number: NCT01292460
• Lead Sponsor: Santen Oy

Brief Summary

The purpose of this study is to compare the efficacy and safety of the preservative-free fixed tafluprost-timolol combination to those of tafluprost and timolol alone. This study will enroll patients who have ocular hypertension or glaucoma and who are using timolol or prostaglandin.

The study medication period is 6 months, but the primary evaluation of efficacy is done at 3 months.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-02
• Study First Submitted: 2011-02-08
• Study First Submitted QC: 2011-02-08
• Study First Posted: 2011-02-09
• Status Verified: 2011-03
• Primary Completion: 2012-09
• Study Completion: 2012-09
• Last Update Submitted: 2013-03-12
• Last Update Posted: 2013-03-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 600

Inclusion Criteria

• Aged 18 years or more
• 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

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Exclusion Criteria

• Females who are pregnant, nursing or planning pregnancy
• 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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Preservative-free timolol	Timolol/ FDC/ Placebo/ Tafluprost	-
Preservative-free FDC and placebo	Timolol/ FDC/ Placebo/ Tafluprost	-
Preservative-free tafluprost	Timolol/ FDC/ Placebo/ Tafluprost	-
Preservative-free FDC	Timolol/ FDC/ Placebo/ Tafluprost	-

Primary Outcome Measures

Name	Time	Method
Change from baseline in the average diurnal Intraocular Pressure (IOP) at 3 months	At 3 months

Secondary Outcome Measures

Name	Time	Method
Change from baseline in average diurnal IOP	At 2 and 6 weeks and 6 months	Change from baseline in the average diurnal IOP at 2 weeks, 6 weeks and 6 months
Change from baseline in timewise IOPs	At 2 weeks, 6 weeks, 3 months and 6 months	Change from baseline in timewise IOPs (at 8:00, 10:00, 16:00, 20:00)

Trial Locations

Locations (2)

Eye Clinic, University Hospital of Oulu; 🇫🇮 Oulu, Finland

Eye clinic, University Hospital of Kuopio; 🇫🇮 Kuopio, Finland