Open-Angle GlaucomaPhase 3NCT00918346

Pharmacodynamics of Tafluprost 0.0015% Eye Drops: a Comparison Between the Preserved and Unpreserved Formulation

A Phase 3 study testing Tafluprost 0.0015% in people with Open-Angle Glaucoma and Ocular Hypertension, run by Santen Oy at 3 sites in 2 countries.

Completed

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

Official record

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Trial summary

The objective of this study is to investigate the pharmacodynamics (as expressed in intraocular pressure [IOP]) of two formulations of tafluprost 0.0015% eyedrops (preserved and unpreserved) in patients with open-angle glaucoma or ocular hypertension. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Open-Angle Glaucoma, Ocular Hypertension
What is being tested?: Tafluprost 0.0015%
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 43 participants
Where: 3 sitesin 2 countries
Study dates: Sep 2005to Apr 2006
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

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

Age 18 years or more
A diagnosis of open angle glaucoma or ocular hypertension
Prior use of prostaglandin(s)
Intra ocular pressure of 22-34 mmHg in at least one eye

Who cannot join

Females who are pregnant, nursing or planning a pregnancy, or females of childbearing potential who are not using a reliable method of contraception
Previous participation in any clinical trial in which tafluprost was an investigational drug or 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 study

Trial locations and contacts

3 sites in 2 countries.

Country

City, postcode or hospital

3 sites in 2 countries

Germany2 sites

Ulrich Richter's surgery
Regensburg, 93059
Praxis Dr. Hamacher
Starnberg, 82319

Other trials in Germany

Finland1 site

Oulu University Hospital
Oulu, 90029

Other trials in Finland

About this study

Official title: Pharmacodynamics of Tafluprost 0.0015% Eye Drops: a Comparison Between the Preserved and Unpreserved Formulation in Patients With Open-angle Glaucoma or Ocular Hypertension

The primary aim of this study is to show that IOP reduction between the two formulations is equivalent at the end of the 4 week treatment period.

Conditions: Open-Angle Glaucoma, Ocular Hypertension
Being tested: Tafluprost 0.0015%
Keywords: Ocular hypertension
Medical subject headings: Glaucoma, Open-Angle, Ocular Hypertension

What participants receive

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

Tafluprost 0.0015%Drug
Eye drops, 0.015 mg/ml, once daily to affected eye(s)

Study groups in NCT00918346
Study group	Role	What they receive
Tafluprost 0.0015% preserved formulation	Experimental	Not described Receives: Drug: Tafluprost 0.0015%
Tafluprost 0.0015% unpreserved formulation	Experimental	Not described Receives: Drug: Tafluprost 0.0015%

What is being measured

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

Intraocular Pressures (IOPs) at Baseline
IOPs at baseline: mean IOP values at four timepoints (worse eye)
Measured: Baseline
Intraocular Pressures (IOPs) at Week 1
IOPs at week 1: mean IOP values at four timepoints (worse eye)
Measured: Week 1
Intraocular Pressures (IOPs) at Week 4
IOPs at week 4: mean IOP values at four timepoints (worse eye)
Measured: Week 4
Primary Pharmacodynamic Variable Intention to Treat Efficacy Dataset: Change From Baseline in the Overall Diurnal Intraocular Pressure (IOP) at Week 4 (Worse Eye)
Overall treatment difference at 4 weeks (unpreserved-preserved) evaluated using a repeated measurements analysis of covariance (RM ANCOVA) model.
Measured: Baseline - Week 4
Primary Pharmacodynamic Variable Per Protocol Efficacy Dataset: Change From Baseline in the Overall Diurnal Intraocular Pressure (IOP) at Week 4 (Worse Eye)
Overall treatment difference at 4 weeks (unpreserved-preserved) evaluated using a repeated measurments analysis of covariance (RM ANCOVA) model.
Measured: Baseline - Week 4

Secondary outcomes (2)

Overall and Time-wise Comparisons of IOP at Week 1
The overall and time-wise, i.e. at 8:00, 12:00, 16:00 and 20:00, comparisons of IOP at week 1 (diurnal IOP and IOP value at given timepoint at 1 week minus corresponding value at baseline: unpreserved-preserved) were done using the RM ANCOVA model.
Measured: Baseline - Week 1
Change From Baseline in Time-wise IOPs at Week 4
The time-wise, i.e. at 8:00, 12:00, 16:00 and 20:00, comparisons of IOP at week 4 (IOP value at given timepoint at 4 weeks minus corresponding value at baseline: unpreserved-preserved) were done using the RM ANCOVA model.
Measured: Baseline - Week 4

Timeline

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

Sep 2005Apr 2006

First posted11 Jun 2009 (estimated)
Study startSep 2005
Primary completionMar 2006
Study completionApr 2006

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Open-Angle GlaucomaStudies 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: Crossover
Masking: Single blind
Who is masked: Investigator
Enrolment: 43 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00918346
Sponsor's protocol ID: 77550
Status last verified: Dec 2010
First submitted: 9 Jun 2009
Last updated: 28 Dec 2010
Results posted: Yes, on ClinicalTrials.gov
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

RecruitingPhase 2
A Phase 2a Study Comparing the Efficacy, Safety and Tolerability of Pregabalin Eye Drops Comparing With Timolol Eye Drops in Adults With Glaucoma or High Eye Pressure.
Primary Open - Angle Glaucoma (POAG), Ocular Hypertension (OHT)
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
RecruitingPhase 4
Adaptive Optics OCT Evaluation of Rhopressa's Effects on the Retinal Ganglion Cells in Glaucoma Patients
Open Angle Glaucoma (OAG), Glaucoma
RecruitingObservational study
PRESERFLO™ MicroShunt XI Observational PMCF Study With no Control Group
Primary Open Angle Glaucoma
Active, not recruitingObservational study
Glaucoma, Visual Field Loss, and Their Association With Life Space in Older Adults
Primary Open Angle Glaucoma

All Open-Angle Glaucoma trials

Study at a glance

From the registry record, last updated by the sponsor on 28 Dec 2010. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Pharmacodynamics of Tafluprost 0.0015% Eye Drops: a Comparison Between the Preserved and Unpreserved Formulation in Patients With Open-angle Glaucoma or Ocular Hypertension
ClinicalTrials.gov ID: NCT00918346
Acronym / sponsor ID: 77550
Conditions: Open-Angle Glaucoma, Ocular Hypertension
Keywords: Ocular hypertension
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 43 participants (actual)
Lead sponsor: Santen OyIndustry (pharma, biotech, devices)
Study start: Sep 2005
Primary completion: Mar 2006 (actual)
Study completion: Apr 2006 (actual)
First posted: 11 Jun 2009 (estimated)
Results: Posted 15 Sep 2009

Clinical summary

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

The primary aim of this study is to show that IOP reduction between the two formulations is equivalent at the end of the 4 week treatment period.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Single blind (investigator)
Number of arms: 2

Arm	Type	Receives
Tafluprost 0.0015% preserved formulation	Experimental	Drug: Tafluprost 0.0015%
Tafluprost 0.0015% unpreserved formulation	Experimental	Drug: Tafluprost 0.0015%

Who may qualify

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

Key inclusion criteria (4 listed)

Age 18 years or more
A diagnosis of open angle glaucoma or ocular hypertension
Prior use of prostaglandin(s)
Intra ocular pressure of 22-34 mmHg in at least one eye

Key exclusion criteria (3 listed)

Females who are pregnant, nursing or planning a pregnancy, or females of childbearing potential who are not using a reliable method of contraception
Previous participation in any clinical trial in which tafluprost was an investigational drug or 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 study

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
Tafluprost 0.0015%Eye drops, 0.015 mg/ml, once daily to affected eye(s)	Drug	Tafluprost 0.0015% preserved formulation, Tafluprost 0.0015% unpreserved formulation

Primary outcome

Intraocular Pressures (IOPs) at Baseline
Time frame: Baseline
IOPs at baseline: mean IOP values at four timepoints (worse eye)
Intraocular Pressures (IOPs) at Week 1
Time frame: Week 1
IOPs at week 1: mean IOP values at four timepoints (worse eye)
Intraocular Pressures (IOPs) at Week 4
Time frame: Week 4
IOPs at week 4: mean IOP values at four timepoints (worse eye)
Primary Pharmacodynamic Variable Intention to Treat Efficacy Dataset: Change From Baseline in the Overall Diurnal Intraocular Pressure (IOP) at Week 4 (Worse Eye)
Time frame: Baseline - Week 4
Overall treatment difference at 4 weeks (unpreserved-preserved) evaluated using a repeated measurements analysis of covariance (RM ANCOVA) model.
Primary Pharmacodynamic Variable Per Protocol Efficacy Dataset: Change From Baseline in the Overall Diurnal Intraocular Pressure (IOP) at Week 4 (Worse Eye)
Time frame: Baseline - Week 4
Overall treatment difference at 4 weeks (unpreserved-preserved) evaluated using a repeated measurments analysis of covariance (RM ANCOVA) model.

2 secondary outcomes

Overall and Time-wise Comparisons of IOP at Week 1
Time frame: Baseline - Week 1
Change From Baseline in Time-wise IOPs at Week 4
Time frame: Baseline - Week 4

Results and safety

Results posted to the registry on 15 Sep 2009, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Preserved Formulation First, Then Unpreserved Formulation	21	21
Unpreserved Formulation First, Then Preserved Formulation	22	21

Primary outcome: Intraocular Pressures (IOPs) at Baseline

Time frame: Baseline. Mean (Standard Deviation). Unit: mmHg

Measure	Preserved Formulation n = 42	Unpreserved Formulation n = 43
8 o'clock	22.57 (3.04)	22.98 (3.18)
12 o'clock	20.86 (2.79)	21.78 (2.68)
16 o'clock	21.73 (3.19)	21.51 (2.49)
20 o'clock	21.77 (3.02)	21.81 (2.61)

Population analysed: IOPs of all subjects who received preserved/unpreserved formulation

Primary outcome: Intraocular Pressures (IOPs) at Week 1

Time frame: Week 1. Mean (Standard Deviation). Unit: mmHg

Measure	Preserved Formulation n = 42	Unpreserved Formulation n = 43
8 o'clock	16.43 (2.11)	16.21 (2.70)
12 o'clock	15.77 (1.60)	15.72 (1.92)
16 o'clock	16.23 (1.73)	15.83 (1.99)
20 o'clock	16.26 (2.20)	16.16 (2.08)

Population analysed: IOPs of all subjects who received preserved/unpreserved formulation

Primary outcome: Intraocular Pressures (IOPs) at Week 4

Time frame: Week 4. Mean (Standard Deviation). Unit: mmHg

Measure	Preserved Formulation n = 42	Unpreserved Formulation n = 43
8 o'clock	16.39 (2.43)	16.80 (3.00)
12 o'clock	16.30 (2.46)	16.67 (2.54)
16 o'clock	16.64 (2.37)	16.71 (2.53)
20 o'clock	17.21 (1.91)	17.01 (2.44)

Population analysed: IOPs of all subjects who received preserved/unpreserved formulation

Primary outcome: Primary Pharmacodynamic Variable Intention to Treat Efficacy Dataset: Change From Baseline in the Overall Diurnal Intraocular Pressure (IOP) at Week 4 (Worse Eye)

Time frame: Baseline - Week 4. Mean (95% Confidence Interval). Unit: mmHg

Measure	RM ANCOVA: ITT Efficacy Dataset n = 43
Value	0.01 (-0.46 to 0.49)

RM ANCOVA: ITT Efficacy Dataset: Mean Difference (Final Values): 0.01 (95% CI -0.46 to 0.49), p = 0.96, ANCOVA

Population analysed: Intention To Treat (ITT): randomized patients who received at least one dose of study medication and had at least one pharmacodynamic (IOP) measurement available.

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse event data was collected at Week 1 and Week 4 visits of treatment period I and II, as well as on last Post-study visit. Additionally, baseline symptoms were queried on Day 0 (=Baseline) visit of the two treatment periods.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Preserved Formulation	0 of 42 (0%)	7 of 42 (16.7%)	Not reported
Unpreserved Formulation	0 of 43 (0%)	11 of 43 (25.6%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 28 Dec 2010.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Open-Angle Glaucoma

RecruitingPhase 2
A Phase 2a Study Comparing the Efficacy, Safety and Tolerability of Pregabalin Eye Drops Comparing With Timolol Eye Drops in Adults With Glaucoma or High Eye Pressure.
Primary Open - Angle Glaucoma (POAG), Ocular Hypertension (OHT)
Recruiting
The Acute Effect of Exercise Type And Timing on Ambulatory Blood Pressure and Intra-Ocular Pressure in Individuals With Glaucoma (The ACHIEVE-project).
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RecruitingPhase 4
Adaptive Optics OCT Evaluation of Rhopressa's Effects on the Retinal Ganglion Cells in Glaucoma Patients
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PRESERFLO™ MicroShunt XI Observational PMCF Study With no Control Group
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Active, not recruitingObservational study
Glaucoma, Visual Field Loss, and Their Association With Life Space in Older Adults
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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.

Juhani Airaksinen, Prof. principal investigator

University Hospital of Oulu

3 sites in 2 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Tafluprost 0.0015% in people with Open-Angle Glaucoma and Ocular Hypertension, run by Santen Oy at 3 sites in 2 countries.

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 4 inclusion and 3 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 28 Dec 2010. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Germany, Finland. 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?

Yes. Results are posted in the registry (first posted 15 Sep 2009). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Intraocular Pressures (IOPs) at Baseline (time frame: Baseline). The study lists 5 primary outcomes in all. 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 NCT00918346.

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 28 Dec 2010.