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

Primary Purpose

Ocular Hypertension, Open-angle Glaucoma

Status

Completed

Phase

Phase 3

Locations

Hungary

Study Type

Interventional

Intervention

Timolol and Tafluprost

Fixed Dose Combination of tafluprost and timolol

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
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:

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Timolol and Tafluprost

Fixed Dose Combination of tafluprost and timolol

Arm Description

Concomitant administration of preservative-free timolol and tafluprost eye drops

Preservative-free Fixed Dose Combination of tafluprost and timolol eye drops

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Change from baseline in average diurnal IOP at 2 weeks, 6 weeks and 3 months

Change from baseline in timewise IOPs

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

Full Information

NCT ID

NCT01306461

First Posted

February 28, 2011

Last Updated

June 7, 2012

Sponsor

Santen Oy

1. Study Identification

Unique Protocol Identification Number

NCT01306461

Brief Title

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

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 of Tafluprost and Timolol Eye Drops Given Concomitantly in Patients With Open Angle Glaucoma or Ocular Hypertension

Study Type

Interventional

2. Study Status

Record Verification Date

June 2012

Overall Recruitment Status

Completed

Study Start Date

March 2011 (undefined)

Primary Completion Date

April 2012 (Actual)

Study Completion Date

May 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-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

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

401 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Timolol and Tafluprost

Arm Type

Active Comparator

Arm Description

Concomitant administration of preservative-free timolol and tafluprost eye drops

Arm Title

Fixed Dose Combination of tafluprost and timolol

Arm Type

Experimental

Arm Description

Preservative-free Fixed Dose Combination of tafluprost and timolol eye drops

Intervention Type

Drug

Intervention Name(s)

Timolol and Tafluprost

Intervention Description

Preservative-free Timolol eye drops administered twice daily concomitantly with preservative-free Tafluprost eye drops administered once daily Treatment period 6 months

Intervention Type

Drug

Intervention Name(s)

Fixed Dose Combination of tafluprost and timolol

Intervention Description

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

Primary Outcome Measure Information:

Title

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

Time Frame

6 months

Secondary Outcome Measure Information:

Title

Change from baseline in average diurnal IOP at 2 weeks, 6 weeks and 3 months

Time Frame

2 weeks, 6 weeks and 3 months

Title

Change from baseline in timewise IOPs

Description

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

Time Frame

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 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: 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

Overall Study Officials: