Open-angle GlaucomaPhase 3NCT01026831

Preservative-Free MK2452 (Tafluprost) for Open-Angle Glaucoma/Ocular Hypertension (MK2452-001)(COMPLETED)

A Phase 3 study testing Preservative-Free Tafluprost and Comparator: timolol in people with Open-angle Glaucoma and Ocular Hypertension, run by Merck Sharp & Dohme LLC.

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

Who is it for?: Ages 18 years and older
Conditions the study is for: Open-angle Glaucoma, Ocular Hypertension
What is being tested?: Preservative-Free Tafluprost and Comparator: timolol
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 643 participants
Where: No sites listed yet
Study dates: 6 Jan 2010to 17 Sep 2010
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

Patient has been diagnosed with primary open-angle glaucoma, pigmentary glaucoma, capsular glaucoma/pseudoexfoliation, or ocular hypertension
Patient has a mean (or median) IOP of >=23 and =<36 in at least one eye at the 0800 hours time point at the Baseline Visit.
Patient has <5 mmHg difference in mean (or median) IOP between eyes at each time point (0800 hours, 1000 hours, and 1600 hours) at Baseline.
Patient is currently using a prescribed ocular hypotensive medication and has been on a stable dose for 30 days prior to screening, or patient is drug-naive (those who have never used or who have not used ocular hypotensive medication for at least 4 weeks prior to screening)
Patient is able to safely discontinue current ocular hypotensive medication during up to the 4-week washout period
Patient has vision corrected to 20/80 or better in each eye

Show all 10Show fewer

Patient is willing and able to avoid wearing contact lenses from 4 weeks prior to dosing through 24 hour after final dosing
Patient is willing and able to self-administer or has an able person available on a daily basis to assist with administration of study medications
Patient is not pregnant and not planning to become pregnant during the study
Patient is male or female ≥18 of age on the day of signing the informed consent

Who cannot join

Patient is unable to use study medication in the affected eye(s)
Patient has a history of inflammatory ocular surface disease or anterior or posterior uveitis in either eye
Patient has a history of retinal detachment, diabetic retinopathy, or other progressive retinal disease
Patient has experienced significant visual field loss within the last year
Patient has had intraocular surgery in either eye in the last 4 months
Patient has a history of glaucoma surgery or refractive surgery in either eye

Show all 11Show fewer

Patient is currently taking two or more anti-glaucoma medications (except Cosopt™ or its generic formulation)
Patient has previously used tafluprost
Patient has a history of cardiovascular disorder within 6 months prior to screening
Patient has a history of bronchial asthma, wheezing, pneumonia, COPD, other pulmonary disease, or abnormal chest x-ray
Patient has a mean (or median) IOP >36 mmHg in either eye at the Screening Visit or at any time point (0800 hours, 1000 hours, and 1600 hours) of the Baseline Visit.

About this study

Official title: A Phase III, Randomized, Active Comparator-Controlled, Twelve-Week, Double-Masked Clinical Trial to Compare the Efficacy and Safety of Preservative-Free MK2452 (0.0015%) and Preservative-Free Timolol Maleate (0.5%) in Patients With Open-Angle Glaucoma and Ocular Hypertension

This study was to compare the safety and efficacy of the preservative-free formulation of 0.0015% MK2452 (tafluprost) and preservative-free 0.5% timolol maleate in patients with open-angle glaucoma and ocular hypertension. This study was to demonstrate that the preservative-free formulation of 0.0015% tafluprost is non-inferior to preservative-free 0.5% timolol maleate.

Conditions: Open-angle Glaucoma, Ocular Hypertension
Being tested: Preservative-Free Tafluprost, Comparator: timolol
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.

Preservative-Free TafluprostDrug
Also called MK2452
One drop of preservative-free vehicle per eye in the morning, and one drop of preservative-free tafluprost (0.0015%) per eye in the evening for 12 weeks
Comparator: timololDrug
One drop of preservative-free timolol maleate (0.5%) per eye twice daily for 12 weeks

Study groups in NCT01026831
Study group	Role	What they receive
Tafluprost	Experimental	Preservative-free tafluprost Receives: Drug: Preservative-Free Tafluprost
timolol maleate	Active comparator	Preservative-free timolol maleate Receives: Drug: Comparator: timolol

What is being measured

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

Mean Intraocular Pressure (IOP) Change From Baseline at All 9 Time Points During the Study (0800, 1000 and 1600 Hrs at Weeks 2, 6, and 12)
IOP was measured using a Goldmann applanation tonometer. The primary evaluation was based on the study eye (the worse eye based on the 0800 hour IOP baseline or the right eye when both eyes had the same IOP).
IOP change from baseline was calculated using the baseline IOP at each time point (0800 hours at baseline to 0800 hours at Week 2, 6, and 12; 1000 hours at baseline to 1000 hours at Week 2, 6, and 12; 1600 hours at baseline to 1600 hours at Week 2, 6, and 12).
Lowering elevated IOP is a treatment goal of glaucoma.
Measured: Baseline, Weeks 2, 6, and 12.

Timeline

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

6 Jan 201017 Sep 2010

First posted4 Dec 2009 (estimated)
Study start6 Jan 2010
Primary completion17 Sep 2010
Study completion17 Sep 2010

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.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Open-angle GlaucomaStudies of the same condition, open and under way.
More trials run by Merck Sharp & Dohme LLCThe sponsor's other registered studies.
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: Double blind
Who is masked: Participant, Investigator
Enrolment: 643 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01026831
Sponsor's protocol ID: 2452-001
Other IDs: 2009_701
Status last verified: May 2017
First submitted: 2 Dec 2009
Last updated: 21 Jun 2017
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: Yes: http://www.merck.com/clinical-trials/pdf/Merck%20Procedure%20on%20Clinical%20Trial%20Data%20Access%20Final\_Updated%20July\_9\_2014.pdf http://engagezone.msd.com/ds\_documentation.php

Publications

Chabi A, Varma R, Tsai JC, Lupinacci R, Pigeon J, Baranak C, Noble L, Lines C, Ho TW. Randomized clinical trial of the efficacy and safety of preservative-free tafluprost and timolol in patients with open-angle glaucoma or ocular hypertension. Am J Ophthalmol. 2012 Jun;153(6):1187-96. doi: 10.1016/j.ajo.2011.11.008. Epub 2012 Feb 4.
PubMed 22310086

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?

Official record

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 21 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase III, Randomized, Active Comparator-Controlled, Twelve-Week, Double-Masked Clinical Trial to Compare the Efficacy and Safety of Preservative-Free MK2452 (0.0015%) and Preservative-Free Timolol Maleate (0.5%) in Patients With Open-Angle Glaucoma and Ocular Hypertension
ClinicalTrials.gov ID: NCT01026831
Acronym / sponsor ID: 2452-001
Conditions: Open-angle Glaucoma, Ocular Hypertension
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 643 participants (actual)
Lead sponsor: Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
Study start: 6 Jan 2010 (actual)
Primary completion: 17 Sep 2010 (actual)
Study completion: 17 Sep 2010 (actual)
First posted: 4 Dec 2009 (estimated)
Results: Posted 13 Sep 2011

Clinical summary

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

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
Tafluprost	Experimental	Drug: Preservative-Free TafluprostPreservative-free tafluprost
timolol maleate	Active comparator	Drug: Comparator: timololPreservative-free timolol maleate

Who may qualify

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

Key inclusion criteria (10 listed)

Patient has been diagnosed with primary open-angle glaucoma, pigmentary glaucoma, capsular glaucoma/pseudoexfoliation, or ocular hypertension
Patient has a mean (or median) IOP of >=23 and =<36 in at least one eye at the 0800 hours time point at the Baseline Visit.
Patient has <5 mmHg difference in mean (or median) IOP between eyes at each time point (0800 hours, 1000 hours, and 1600 hours) at Baseline.
Patient is currently using a prescribed ocular hypotensive medication and has been on a stable dose for 30 days prior to screening, or patient is drug-naive (those who have never used or who have not used ocular hypotensive medication for at least 4 weeks prior to screening)
Patient is able to safely discontinue current ocular hypotensive medication during up to the 4-week washout period

Key exclusion criteria (11 listed)

Patient is unable to use study medication in the affected eye(s)
Patient has a history of inflammatory ocular surface disease or anterior or posterior uveitis in either eye
Patient has a history of retinal detachment, diabetic retinopathy, or other progressive retinal disease
Patient has experienced significant visual field loss within the last year
Patient has had intraocular surgery in either eye in the last 4 months

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
Preservative-Free TafluprostAlso: MK2452One drop of preservative-free vehicle per eye in the morning, and one drop of preservative-free tafluprost (0.0015%) per eye in the evening for 12 weeks	Drug	Tafluprost
Comparator: timololOne drop of preservative-free timolol maleate (0.5%) per eye twice daily for 12 weeks	Drug	timolol maleate

Primary outcome

Mean Intraocular Pressure (IOP) Change From Baseline at All 9 Time Points During the Study (0800, 1000 and 1600 Hrs at Weeks 2, 6, and 12)
Time frame: Baseline, Weeks 2, 6, and 12.
IOP was measured using a Goldmann applanation tonometer. The primary evaluation was based on the study eye (the worse eye based on the 0800 hour IOP baseline or the right eye when both eyes had the same IOP). IOP change from baseline was calculated using the baseline IOP at each time point (0800 hours at baseline to 0800 hours at Week 2, 6, and 12; 1000 hours at baseline to 1000 hours at Week 2, 6, and 12; 1600 hours at baseline to 1600 hours at Week 2, 6, and 12). Lowering elevated IOP is a treatment goal of glaucoma.

Results and safety

Results posted to the registry on 13 Sep 2011, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Tafluprost	320	306
Timolol Maleate	323	312

Primary outcome: Mean Intraocular Pressure (IOP) Change From Baseline at All 9 Time Points During the Study (0800, 1000 and 1600 Hrs at Weeks 2, 6, and 12)

Time frame: Baseline, Weeks 2, 6, and 12.. Least squares mean (95% Confidence Interval). Unit: mmHg

Measure	Tafluprost n = 299	Timolol Maleate n = 313
Week 2 - 0800 (n=280; n=295)	-7.1 (-7.5 to -6.8)	-6.8 (-7.1 to -6.5)
Week 2 - 1000 (n=293; n=305)	-6.8 (-7.1 to -6.5)	-6.1 (-6.4 to -5.8)
Week 2 - 1600 (n=289; n=302)	-6.2 (-6.5 to -5.9)	-5.3 (-5.7 to -5.0)
Week 6 - 0800 (n=294; n=308)	-7.3 (-7.6 to -6.9)	-7.4 (-7.7 to -7.1)
Week 6 - 1000 (n=298; n=312)	-7.0 (-7.3 to -6.7)	-6.6 (-6.9 to -6.3)
Week 6 - 1600 (n=295; n=310)	-6.3 (-6.7 to -6.0)	-5.5 (-5.9 to -5.2)
Week 12 - 0800 (n=296; n=308)	-7.4 (-7.8 to -7.1)	-7.5 (-7.8 to -7.1)
Week 12 - 1000 (n=298; n=312)	-7.0 (-7.4 to -6.7)	-6.6 (-7.0 to -6.3)

Population analysed: The Per-Protocol (PP) approach excluded all patients with important protocol violations and was performed for the efficacy endpoints. The PP population excluded patients due to important deviations from the protocol that may have substantially affected the results of the primary endpoints.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Tafluprost	2 of 320 (0.6%)	0 of 320 (0%)	Not reported
Timolol Maleate	7 of 323 (2.2%)	0 of 323 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 21 Jun 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 22310086Chabi A, Varma R, Tsai JC, Lupinacci R, Pigeon J, Baranak C, Noble L, Lines C, Ho TW. Randomized clinical trial of the efficacy and safety of preservative-free tafluprost and timolol in patients with open-angle glaucoma or ocular hypertension. Am J Ophthalmol. 2012 Jun;153(6):1187-96. doi: 10.1016/j.ajo.2011.11.008. Epub 2012 Feb 4.
Individual participant dataSharing planned: Yes. http://www.merck.com/clinical-trials/pdf/Merck%20Procedure%20on%20Clinical%20Trial%20Data%20Access%20Final_Updated%20July_9_2014.pdf http://engagezone.msd.com/ds_documentation.php

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.
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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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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.

Medical Monitor study director

Merck Sharp & Dohme LLC

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Preservative-Free Tafluprost and Comparator: timolol in people with Open-angle Glaucoma and Ocular Hypertension, run by Merck Sharp & Dohme LLC.

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 10 inclusion and 11 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 21 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.

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 13 Sep 2011). 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?

Mean Intraocular Pressure (IOP) Change From Baseline at All 9 Time Points During the Study (0800, 1000 and 1600 Hrs at Weeks 2, 6, and 12) (time frame: Baseline, Weeks 2, 6, and 12.). 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 NCT01026831, which also lists 1 linked publication.

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 21 Jun 2017.