Ocular HypertensionPhase 3NCT01306461

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

A Phase 3 study testing Timolol and Tafluprost and Fixed Dose Combination of tafluprost and timolol in people with Ocular Hypertension and Open-angle Glaucoma, run by Santen Oy at 1 site in Hungary.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial 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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Ocular Hypertension, Open-angle Glaucoma
What is being tested?: Timolol and Tafluprost and Fixed Dose Combination of tafluprost and timolol
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 401 participants
Where: 1 siteHungary
Study dates: Mar 2011to May 2012
Phase: Phase 3
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Hungary1 site

Study site
Debrecen

Other trials in Hungary

About this study

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

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

Conditions: Ocular Hypertension, Open-angle Glaucoma
Being tested: Timolol and Tafluprost, Fixed Dose Combination of tafluprost and timolol
Medical subject headings: Ocular Hypertension, Glaucoma, Open-Angle

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Timolol and TafluprostDrug
Preservative-free Timolol eye drops administered twice daily concomitantly with preservative-free Tafluprost eye drops administered once daily
Treatment period 6 months
Fixed Dose Combination of tafluprost and timololDrug
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

Study groups in NCT01306461
Study group	Role	What they receive
Timolol and Tafluprost	Active comparator	Concomitant administration of preservative-free timolol and tafluprost eye drops Receives: Drug: Timolol and Tafluprost
Fixed Dose Combination of tafluprost and timolol	Experimental	Preservative-free Fixed Dose Combination of tafluprost and timolol eye drops Receives: Drug: Fixed Dose Combination of tafluprost and timolol

What is being measured

The primary outcome is the main question the study is designed to answer.

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

Secondary outcomes (2)

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Mar 2011May 2012

First posted1 Mar 2011 (estimated)
Study startMar 2011
Primary completionApr 2012
Study completionMay 2012

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Ocular HypertensionStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 401 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01306461
Sponsor's protocol ID: 201051
Status last verified: Jun 2012
First submitted: 28 Feb 2011
Last updated: 8 Jun 2012
Results posted: No
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Recruiting
Effects of Balance Training in Individuals With Glaucoma
Glaucoma
Not yet recruiting
Glaucoma Drop Aids Part 2
Glaucoma, Intraocular Pressure
Not yet recruiting
PAUL® Glaucoma Implant Safety and Effectiveness Study
Refractory Glaucoma
Recruiting
The Acute Effect of Exercise Type And Timing on Ambulatory Blood Pressure and Intra-Ocular Pressure in Individuals With Glaucoma (The ACHIEVE-project).
Glaucoma Open-Angle Primary, Hypertension
RecruitingObservational study
Anterior Segment Anatomy Assessed by Swept-Source OCT in Ocular Surgery Patients
Cataract, Primary Angle-Closure Glaucoma

All Ocular Hypertension trials

Study at a glance

From the registry record, last updated by the sponsor on 8 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT01306461
Acronym / sponsor ID: 201051
Conditions: Ocular Hypertension, Open-angle Glaucoma
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 401 participants (actual)
Lead sponsor: Santen OyIndustry (pharma, biotech, devices)
Study start: Mar 2011
Primary completion: Apr 2012 (actual)
Study completion: May 2012 (actual)
First posted: 1 Mar 2011 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Timolol and Tafluprost	Active comparator	Drug: Timolol and TafluprostConcomitant administration of preservative-free timolol and tafluprost eye drops
Fixed Dose Combination of tafluprost and timolol	Experimental	Drug: Fixed Dose Combination of tafluprost and timololPreservative-free Fixed Dose Combination of tafluprost and timolol eye drops

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

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

Key exclusion criteria (8 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Timolol and TafluprostPreservative-free Timolol eye drops administered twice daily concomitantly with preservative-free Tafluprost eye drops administered once daily Treatment period 6 months	Drug	Timolol and Tafluprost
Fixed Dose Combination of tafluprost and timololPreservative-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	Drug	Fixed Dose Combination of tafluprost and timolol

Primary outcome

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

2 secondary outcomes

Change from baseline in average diurnal IOP at 2 weeks, 6 weeks and 3 months
Time frame: 2 weeks, 6 weeks and 3 months
Change from baseline in timewise IOPs
Time frame: 2 weeks, 6 weeks, 3 months and 6 months

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2012.

Related trials for Ocular Hypertension

Recruiting
Effects of Balance Training in Individuals With Glaucoma
Glaucoma
Not yet recruiting
Glaucoma Drop Aids Part 2
Glaucoma, Intraocular Pressure
Not yet recruiting
PAUL® Glaucoma Implant Safety and Effectiveness Study
Refractory Glaucoma
Recruiting
The Acute Effect of Exercise Type And Timing on Ambulatory Blood Pressure and Intra-Ocular Pressure in Individuals With Glaucoma (The ACHIEVE-project).
Glaucoma Open-Angle Primary, Hypertension
RecruitingObservational study
Anterior Segment Anatomy Assessed by Swept-Source OCT in Ocular Surgery Patients
Cataract, Primary Angle-Closure Glaucoma

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Auli Ropo, M.D. study director

Santen Oy

Clemens Vass, M.D. principal investigator

Medical University Vienna, Austria

Marieta Kostianeva, M.D. principal investigator

University Mulitiprofile Hospital for Active Treatment Sv.Georgi, Bulgaria

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Timolol and Tafluprost and Fixed Dose Combination of tafluprost and timolol in people with Ocular Hypertension and Open-angle Glaucoma, run by Santen Oy at 1 site in Hungary.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Jun 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Hungary. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change from baseline in the average diurnal intra-ocular pressure (IOP) at 6 months (time frame: 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01306461.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jun 2012.