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

Primary Purpose

Ocular Hypertension, Open-angle Glaucoma

Status

Completed

Phase

Phase 3

Locations

Finland

Study Type

Interventional

Intervention

Timolol/ FDC/ Placebo/ Tafluprost

About this trial

This is an interventional treatment trial for Ocular Hypertension

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

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

Sites / Locations

Eye clinic, University Hospital of Kuopio
Eye Clinic, University Hospital of Oulu

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Experimental

Active Comparator

Experimental

Arm Label

Preservative-free timolol

Preservative-free FDC and placebo

Preservative-free tafluprost

Preservative-free FDC

Arm Description

Outcomes

Primary Outcome Measures

Change from baseline in the average diurnal Intraocular Pressure (IOP) at 3 months

Secondary Outcome Measures

Change from baseline in average diurnal IOP

Change from baseline in the average diurnal IOP at 2 weeks, 6 weeks and 6 months

Change from baseline in timewise IOPs

Change from baseline in timewise IOPs (at 8:00, 10:00, 16:00, 20:00)

Full Information

NCT ID

NCT01292460

First Posted

February 8, 2011

Last Updated

March 12, 2013

Sponsor

Santen Oy

1. Study Identification

Unique Protocol Identification Number

NCT01292460

Brief Title

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

Official Title

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 Given Individually in Patients With Open Angle Glaucoma or Ocular Hypertension

Study Type

Interventional

2. Study Status

Record Verification Date

March 2011

Overall Recruitment Status

Completed

Study Start Date

February 2011 (undefined)

Primary Completion Date

September 2012 (Actual)

Study Completion Date

September 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Santen Oy

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Ocular Hypertension, Open-angle Glaucoma

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

600 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Preservative-free timolol

Arm Type

Active Comparator

Arm Title

Preservative-free FDC and placebo

Arm Type

Experimental

Arm Title

Preservative-free tafluprost

Arm Type

Active Comparator

Arm Title

Preservative-free FDC

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

Timolol/ FDC/ Placebo/ Tafluprost

Intervention Description

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).

Primary Outcome Measure Information:

Title

Change from baseline in the average diurnal Intraocular Pressure (IOP) at 3 months

Time Frame

At 3 months

Secondary Outcome Measure Information:

Title

Change from baseline in average diurnal IOP

Description

Change from baseline in the average diurnal IOP at 2 weeks, 6 weeks and 6 months

Time Frame

At 2 and 6 weeks and 6 months

Title

Change from baseline in timewise IOPs

Description

Change from baseline in timewise IOPs (at 8:00, 10:00, 16:00, 20:00)

Time Frame

At 2 weeks, 6 weeks, 3 months and 6 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Auli Ropo, M.D.

Organizational Affiliation

Santen Oy

Official's Role

Study Director

First Name & Middle Initial & Last Name & Degree

Hannu Uusitalo, M.D., Prof.

Organizational Affiliation

Tampere University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Eye clinic, University Hospital of Kuopio

City

Kuopio

ZIP/Postal Code

70210

Country

Finland

Facility Name

Eye Clinic, University Hospital of Oulu

City

Oulu

ZIP/Postal Code

90029 OYS

Country

Finland

12. IPD Sharing Statement

Citations:

PubMed Identifier

25447269

Citation

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.

Results Reference

derived

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

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