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

Phase 3

Completed

• Conditions: Ocular Hypertension; Open-angle Glaucoma
• Interventions: Drug: Timolol and Tafluprost; Drug: Fixed Dose Combination of tafluprost and timolol

• Registration Number: NCT01306461
• Lead Sponsor: Santen Oy

Brief 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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-02-28
• Study First Submitted QC: 2011-02-28
• Study Start: 2011-03
• Study First Posted: 2011-03-01
• Primary Completion: 2012-04
• Study Completion: 2012-05
• Status Verified: 2012-06
• Last Update Submitted: 2012-06-07
• Last Update Posted: 2012-06-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 401

Inclusion Criteria

• Aged 18 years or more
• 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

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Exclusion Criteria

• Females who are pregnant, nursing or planning pregnancy
• 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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Timolol and Tafluprost	Timolol and Tafluprost	Concomitant administration of preservative-free timolol and tafluprost eye drops
Fixed Dose Combination of tafluprost and timolol	Fixed Dose Combination of tafluprost and timolol	Preservative-free Fixed Dose Combination of tafluprost and timolol eye drops

Primary Outcome Measures

Name	Time	Method
Change from baseline in the average diurnal intra-ocular pressure (IOP) at 6 months	6 months

Secondary Outcome Measures

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