GlaucomaPhase 3NCT01254604

Preservative-Free Tafluprost (MK-2452) for the Treatment of Open-Angle Glaucoma or Ocular Hypertension (MK-2452-002)

A Phase 3 study testing Preservative-Free Timolol maleate in people with 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

This study will test the hypothesis that preservative-free tafluprost (MK-2452) is non-inferior to preservative-free timolol maleate with respect to the diurnal intraocular pressure (IOP) change from baseline after 4 weeks of therapy in participants with open-angle glaucoma or ocular hypertension. Read more about this study

Who is it for?: Ages 18 to 80 years
Conditions the study is for: Glaucoma, Ocular Hypertension
What is being tested?: Preservative-Free Timolol maleate
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 190 participants
Where: No sites listed yet
Study dates: 1 Dec 2011to 9 May 2013
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 to 80 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Participant has been diagnosed with primary open-angle glaucoma, pigmentary glaucoma, capsular glaucoma/pseudoexfoliation, or ocular hypertension
Has been using ocular hypotensive medication on a stable treatment regimen for at least 30 days prior to screening, or is treatment-naive (has never used or has not used ocular hypotensive medication for the last 4 weeks prior to screening)
Able to discontinue all topical and/or systemic ocular hypotensive medication during the washout period (up to 4 weeks pre-study)
Best-corrected early treatment of diabetic retinopathy study (ETDRS) visual acuity of 20/80 or better in each eye
Willing and able to avoid wearing contact lenses from 4 weeks prior to dosing with study medication through 24 hours after final dosing
Willing and able to self-administer or has an able person available on a daily basis to assist with administration of study medications
Participant with reproductive potential must agree to remain abstinent (unless abstinence is not a locally acceptable method of contraception) or use highly effective methods of birth control (hormonal contraceptives, intrauterine device, diaphragm, condoms and vasectomy) within the projected duration of the study
Able to refrigerate study drug at home.

Who cannot join

Mean IOP >36 mmHg in either eye at screening
Unable to use study medication in the affected eye(s)
History of any inflammatory ocular surface disease or a history of anterior or posterior uveitis in either eye within 6 months prior to screening
History of retinal detachment, proliferative diabetic retinopathy, or any progressive retinal disease
Significant visual field loss or evidence of progressive visual loss within the last year
Intraocular surgery in either eye in the last 4 months

Show all 11Show fewer

Any glaucoma surgery, refractive surgery, or penetrating keratoplasty in either eye
Currently on two or more anti-glaucoma medications (except Cosopt™ or its generic formulation)
Previously used tafluprost
History of cardiovascular disorder within 6 months of screening
History of bronchial asthma, wheezing, chronic obstructive pulmonary disease (COPD) or other pulmonary disease, abnormal chest x-ray, or has current active pneumonia.

About this study

Official title: A Phase III, Randomized, Active Comparator-Controlled, Four-Week, Double-Masked Clinical Trial to Compare the Efficacy and Safety of Preservative-Free MK-2452 (0.0015%) and Preservative-Free Timolol Maleate (0.5%) in Patients With Open-Angle Glaucoma or Ocular Hypertension in India

Conditions: Glaucoma, Ocular Hypertension
Being tested: Preservative-Free Tafluprost or vehicle, Preservative-Free Timolol maleate
Keywords: Tafluprost, Glaucoma, Ocular Hypertension, Timolol, Eye Disorder, Preservative-Free, Prostaglandin Analogue
Medical subject headings: Glaucoma, Ocular Hypertension, Eye Diseases

What participants receive

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

Preservative-Free Tafluprost or vehicleDrug
Also called MK-2452
Preservative-free tafluprost (0.0015%) ophthalmic solution; Preservative-free vehicle ophthalmic solution (contains no active drug)
Preservative-Free Timolol maleateDrug
Also called Preservative-Free Timoptic
Preservative-free timolol maleate (0.5%) ophthalmic solution

Study groups in NCT01254604
Study group	Role	What they receive
Tafluprost	Experimental	One drop of preservative-free vehicle (contains no active drug) per eye in the morning, and one drop of preservative-free tafluprost (0.0015%) per eye in the evening for four weeks. Morning dose with vehicle only allows blinding to match twice daily dosing of comparator arm. Receives: Drug: Preservative-Free Tafluprost or vehicle
Timolol	Active comparator	One drop of preservative-free timolol maleate (0.05%) per eye twice daily (morning and evening) for four weeks. Receives: Drug: Preservative-Free Timolol maleate

What is being measured

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

Mean Diurnal IOP Change From Baseline at Week 4 - Study Eye
IOP was measured at baseline, Week 2 and Week 4 using a Goldmann applanation tonometer. At each of these visits, IOP measurement was performed at 0800, 1000 and 1600 hours. At each IOP assessment time point during a visit, 2 consecutive IOP measurements were made. If these 2 measurements differed by ≤2 mmHg, then the average of the 2 IOP values was recorded. If the 2 measurements differed by >2 mmHg, then a third measurement was obtained and the median of these 3 measurements was recorded. The IOP value for a visit (e.g., Week 4) was the mean of the values recorded at the 3 time points during the visit. For each participant, one "study eye" was identified for data summarization and analysis for this primary efficacy outcome measure. The "study eye" was the eye with the higher (i.e., "worse") IOP at baseline, or if both eyes had the same baseline IOP value, the right eye was designated the "study eye." Change from baseline in IOP at Week 4 = Week 4 IOP value - baseline IOP value.
Measured: Baseline and Week 4
Number of Participants With an Adverse Event (AE)
An AE is any unfavorable and unintended change in the structure, function or chemistry of the body temporally associated with study drug administration, whether or not considered related to the study drug. Participants with one or more AEs during the study are counted once in this summary.
Measured: Up to 14 days after Week 4 visit
Number of Participants Who Discontinued Study Drug Due to an AE
An AE is any unfavorable and unintended change in the structure, function or chemistry of the body temporally associated with study drug administration, whether or not considered related to the study drug. Participants who discontinued study drug treatment due to an AE are counted once in this summary.
Measured: Up to Week 4

Secondary outcomes (1)

Number of Participants With ≥25% Reduction in IOP From Baseline to Week 4 - Study Eye
IOP was measured at baseline, Week 2 and Week 4 using a Goldmann applanation tonometer. At each of these visits, IOP measurement was performed at 0800, 1000 and 1600 hours. At each IOP assessment time point during a visit, 2 consecutive IOP measurements were made. If these 2 measurements differed by ≤2 mmHg, then the average of the 2 IOP values was recorded. If the 2 measurements differed by >2 mmHg, then a third measurement was obtained and the median of these 3 measurements was recorded. The IOP value for a visit (e.g., Week 4) was the mean of the values recorded at the 3 time points during the visit. For each participant, one "study eye" was identified for data summarization and analysis. The "study eye" was the eye with the higher (i.e., "worse") IOP at baseline, or if both eyes had the same baseline IOP value, the right eye was designated the "study eye." Percent reduction in IOP at Week 4 = ([baseline IOP value - Week 4 IOP value]/Baseline IOP value)*100.
Measured: Baseline and Week 4

Timeline

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

1 Dec 20119 May 2013

First posted6 Dec 2010 (estimated)
Study start1 Dec 2011
Primary completion9 May 2013
Study completion9 May 2013

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 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: 190 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01254604
Sponsor's protocol ID: 2452-002
Status last verified: Aug 2018
First submitted: 3 Dec 2010
Last updated: 20 Sep 2018
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: Yes: https://www.merck.com/clinical-trials/pdf/ProcedureAccessClinicalTrialData.pdf

Publications

Chabi A, Baranak C, Lupinacci R, Herring WJ. Preservative-free tafluprost in the treatment of open-angle glaucoma or ocular hypertension in India: a phase III clinical trial. Int J Clin Pract. 2016 Jul;70(7):577-86. doi: 10.1111/ijcp.12815. Epub 2016 Jun 13.
PubMed 27292765

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

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Study at a glance

From the registry record, last updated by the sponsor on 20 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase III, Randomized, Active Comparator-Controlled, Four-Week, Double-Masked Clinical Trial to Compare the Efficacy and Safety of Preservative-Free MK-2452 (0.0015%) and Preservative-Free Timolol Maleate (0.5%) in Patients With Open-Angle Glaucoma or Ocular Hypertension in India
ClinicalTrials.gov ID: NCT01254604
Acronym / sponsor ID: 2452-002
Conditions: Glaucoma, Ocular Hypertension
Keywords: Tafluprost, Glaucoma, Ocular Hypertension, Timolol, Eye Disorder, Preservative-Free, Prostaglandin Analogue
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 190 participants (actual)
Lead sponsor: Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
Study start: 1 Dec 2011 (actual)
Primary completion: 9 May 2013 (actual)
Study completion: 9 May 2013 (actual)
First posted: 6 Dec 2010 (estimated)
Results: Posted 9 May 2014

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 Tafluprost or vehicleOne drop of preservative-free vehicle (contains no active drug) per eye in the morning, and one drop of preservative-free tafluprost (0.0015%) per eye in the evening for four weeks. Morning dose with vehicle only allows blinding to match twice daily dosing of comparator arm.
Timolol	Active comparator	Drug: Preservative-Free Timolol maleateOne drop of preservative-free timolol maleate (0.05%) per eye twice daily (morning and evening) for four weeks.

Who may qualify

Ages: 18 to 80 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (8 listed)

Participant has been diagnosed with primary open-angle glaucoma, pigmentary glaucoma, capsular glaucoma/pseudoexfoliation, or ocular hypertension
Has been using ocular hypotensive medication on a stable treatment regimen for at least 30 days prior to screening, or is treatment-naive (has never used or has not used ocular hypotensive medication for the last 4 weeks prior to screening)
Able to discontinue all topical and/or systemic ocular hypotensive medication during the washout period (up to 4 weeks pre-study)
Best-corrected early treatment of diabetic retinopathy study (ETDRS) visual acuity of 20/80 or better in each eye
Willing and able to avoid wearing contact lenses from 4 weeks prior to dosing with study medication through 24 hours after final dosing

Key exclusion criteria (11 listed)

Mean IOP >36 mmHg in either eye at screening
Unable to use study medication in the affected eye(s)
History of any inflammatory ocular surface disease or a history of anterior or posterior uveitis in either eye within 6 months prior to screening
History of retinal detachment, proliferative diabetic retinopathy, or any progressive retinal disease
Significant visual field loss or evidence of progressive visual loss within the last year

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 Tafluprost or vehicleAlso: MK-2452Preservative-free tafluprost (0.0015%) ophthalmic solution; Preservative-free vehicle ophthalmic solution (contains no active drug)	Drug	Tafluprost
Preservative-Free Timolol maleateAlso: Preservative-Free TimopticPreservative-free timolol maleate (0.5%) ophthalmic solution	Drug	Timolol

Primary outcome

Mean Diurnal IOP Change From Baseline at Week 4 - Study Eye
Time frame: Baseline and Week 4
IOP was measured at baseline, Week 2 and Week 4 using a Goldmann applanation tonometer. At each of these visits, IOP measurement was performed at 0800, 1000 and 1600 hours. At each IOP assessment time point during a visit, 2 consecutive IOP measurements were made. If these 2 measurements differed by ≤2 mmHg, then the average of the 2 IOP values was recorded. If the 2 measurements differed by >2 mmHg, then a third measurement was obtained and the median of these 3 measurements was recorded. The IOP value for a visit (e.g., Week 4) was the mean of the values recorded at the 3 time points during the visit. For each participant, one "study eye" was identified for data summarization and analysis for this primary efficacy outcome measure. The "study eye" was the eye with the higher (i.e., "worse") IOP at baseline, or if both eyes had the same baseline IOP value, the right eye was designated the "study eye." Change from baseline in IOP at Week 4 = Week 4 IOP value - baseline IOP value.
Number of Participants With an Adverse Event (AE)
Time frame: Up to 14 days after Week 4 visit
An AE is any unfavorable and unintended change in the structure, function or chemistry of the body temporally associated with study drug administration, whether or not considered related to the study drug. Participants with one or more AEs during the study are counted once in this summary.
Number of Participants Who Discontinued Study Drug Due to an AE
Time frame: Up to Week 4
An AE is any unfavorable and unintended change in the structure, function or chemistry of the body temporally associated with study drug administration, whether or not considered related to the study drug. Participants who discontinued study drug treatment due to an AE are counted once in this summary.

1 secondary outcome

Number of Participants With ≥25% Reduction in IOP From Baseline to Week 4 - Study Eye
Time frame: Baseline and Week 4

Results and safety

Results posted to the registry on 9 May 2014, 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	95	87
Timolol	95	86

Primary outcome: Mean Diurnal IOP Change From Baseline at Week 4 - Study Eye

Time frame: Baseline and Week 4. Least squares mean (95% Confidence Interval). Unit: mmHg

Measure	Tafluprost n = 84	Timolol n = 83
Value	-8.3 (-9.0 to -7.6)	-6.6 (-7.3 to -5.9)

Tafluprost vs Timolol: Difference in Least Squares Means: -1.7 (95% CI -2.6 to -0.7), ANCOVA

Population analysed: Per Protocol population: Participants who received at least one dose of study drug, had at least one efficacy measurement available for an analysis endpoint and did not have any protocol violations that may substantially affect the results of the primary efficacy endpoint

Primary outcome: Number of Participants With an Adverse Event (AE)

Time frame: Up to 14 days after Week 4 visit. Number. Unit: participants

Measure	Tafluprost n = 93	Timolol n = 94
Value	28	32

Tafluprost vs Timolol: Difference in percentage: -3.9 (95% CI -17.3 to 9.4), Miettinen and Nurminen

Population analysed: APaT population

Primary outcome: Number of Participants Who Discontinued Study Drug Due to an AE

Time frame: Up to Week 4. Number. Unit: participants

Measure	Tafluprost n = 93	Timolol n = 94
Value	3	2

Tafluprost vs Timolol: Difference in percentage: 1.1 (95% CI -3.5 to 5.7), Miettinen and Nurminen

Population analysed: APaT population

1 secondary outcome is reported in the full results.

Adverse events

Time frame: Up to 14 days after Week 4 visit. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Tafluprost	0 of 93 (0%)	19 of 93 (20.4%)	Not reported
Timolol	1 of 94 (1.1%)	15 of 94 (16%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 20 Sep 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 27292765Chabi A, Baranak C, Lupinacci R, Herring WJ. Preservative-free tafluprost in the treatment of open-angle glaucoma or ocular hypertension in India: a phase III clinical trial. Int J Clin Pract. 2016 Jul;70(7):577-86. doi: 10.1111/ijcp.12815. Epub 2016 Jun 13.
Individual participant dataSharing planned: Yes. https://www.merck.com/clinical-trials/pdf/ProcedureAccessClinicalTrialData.pdf

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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.

The record lists no contact. Use the official record to reach the sponsor.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Preservative-Free Timolol maleate in people with 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 8 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 20 Sep 2018. 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 9 May 2014). 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 Diurnal IOP Change From Baseline at Week 4 - Study Eye (time frame: Baseline and Week 4). The study lists 3 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 NCT01254604, 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 20 Sep 2018.