GlaucomaPhase 3NCT00449956

MK0507A Clinical Study in Patients With Glaucoma and Ocular Hypertension (0507A-149)(COMPLETED)

A Phase 3 study testing dorzolamide hydrochloride (+) timolol maleate, Comparator: timolol maleate and Comparator: dorzolamide hydrochloride in people with Glaucoma, 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

The clinical study compares safety and efficacy of MK0507A (dorzolamide 1.0% / timolol 0.5%) with 1) timolol 0.5% and with 2) concomitant therapy with dorzolamide 1.0% / timolol 0.5% in patients with glaucoma and ocular hypertension. Read more about this study

Who is it for?: Ages 20 years and older
Conditions the study is for: Glaucoma
What is being tested?: dorzolamide hydrochloride (+) timolol maleate, Comparator: timolol maleate and Comparator: dorzolamide hydrochloride
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 474 participants
Where: No sites listed yet
Study dates: 12 Mar 2007to 16 Feb 2008
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 20 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Patients with glaucoma and ocular hypertension

Who cannot join

History of ocular surgery within 3 months
Administration contradiction to timolol and dorzolamide

About this study

Official title: Multicenter, Double-Blind, Active Comparator-controlled Study to Evaluate the Safety and Efficacy of MK0507A in Patients With Glaucoma and Ocular Hypertension Who Are Inadequately Controlled on Beta-Blockers

Conditions: Glaucoma
Being tested: dorzolamide hydrochloride (+) timolol maleate, Comparator: timolol maleate, Comparator: dorzolamide hydrochloride
Medical subject headings: Glaucoma

What participants receive

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

dorzolamide hydrochloride (+) timolol maleateDrug
Dorzolamide hydrochloride 1% + timolol 0.5%, 8-week
Comparator: timolol maleateDrug
timolol maleate 0.5%, 8-week
Comparator: dorzolamide hydrochlorideDrug
dorzolamide hydrochloride 1%, 8-week

Study groups in NCT00449956
Study group	Role	What they receive
1	Experimental	combination of dorzolamide hydrochloride and timolol maleate Receives: Drug: dorzolamide hydrochloride (+) timolol maleate
2	Active comparator	Concomitant use of dorzolamide hydrochloride and timolol maleate Receives: Drug: Comparator: timolol maleate; Drug: Comparator: dorzolamide hydrochloride
3	Active comparator	timolol maleate Receives: Drug: Comparator: timolol maleate

What is being measured

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

Change in Intraocular Pressure (IOP) From Baseline at 8 Weeks
Change from baseline to 8 weeks in Intraocular Pressure (IOP) assessed 2 hours after ocular instillation (at Hour 2)
Measured: 8 weeks

Secondary outcomes (2)

Percent Change From Baseline in Intraocular Pressure (IOP) at 8 Weeks
Percent Change from baseline to 8 weeks in Intraocular Pressure (IOP) assessed 2 hours after ocular instillation (at Hour 2)
Measured: 8 Weeks
Percent Change From Baseline in Outflow Pressure Reduction Rate at 8 Weeks
Percent Change from baseline to 8 weeks in Outflow Pressure Reduction Rate assessed 2 hours after ocular instillation (at Hour 2)
Measured: 8 weeks

Timeline

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

12 Mar 200716 Feb 2008

First posted21 Mar 2007 (estimated)
Study start12 Mar 2007
Primary completion16 Feb 2008
Study completion16 Feb 2008

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: 474 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00449956
Sponsor's protocol ID: 0507A-149
Other IDs: MK0507A-149, 2007_011
Status last verified: May 2017
First submitted: 19 Mar 2007
Last updated: 20 Jun 2017
Results posted: Yes, on ClinicalTrials.gov
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

Kitazawa Y, Araie M; Research Group on MK-0507A. [Double-masked, phase III comparative study of the combination ophthalmic solution of the 1% dorzolamide hydrochloride/0.5% timolol maleate (MK-0507A) in patients with glaucoma and ocular hypertension]. Nippon Ganka Gakkai Zasshi. 2011 Jun;115(6):495-507. Japanese.
PubMed 21735753

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

Official title: Multicenter, Double-Blind, Active Comparator-controlled Study to Evaluate the Safety and Efficacy of MK0507A in Patients With Glaucoma and Ocular Hypertension Who Are Inadequately Controlled on Beta-Blockers
ClinicalTrials.gov ID: NCT00449956
Acronym / sponsor ID: 0507A-149
Conditions: Glaucoma
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 474 participants (actual)
Lead sponsor: Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
Study start: 12 Mar 2007 (actual)
Primary completion: 16 Feb 2008 (actual)
Study completion: 16 Feb 2008 (actual)
First posted: 21 Mar 2007 (estimated)
Results: Posted 29 May 2009

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: 3

Arm	Type	Receives
1	Experimental	Drug: dorzolamide hydrochloride (+) timolol maleatecombination of dorzolamide hydrochloride and timolol maleate
2	Active comparator	Drug: Comparator: timolol maleate, Drug: Comparator: dorzolamide hydrochlorideConcomitant use of dorzolamide hydrochloride and timolol maleate
3	Active comparator	Drug: Comparator: timolol maleatetimolol maleate

Who may qualify

Ages: 20 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (1 listed)

Patients with glaucoma and ocular hypertension

Key exclusion criteria (2 listed)

History of ocular surgery within 3 months
Administration contradiction to timolol and dorzolamide

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
dorzolamide hydrochloride (+) timolol maleateDorzolamide hydrochloride 1% + timolol 0.5%, 8-week	Drug	1
Comparator: timolol maleatetimolol maleate 0.5%, 8-week	Drug	2, 3
Comparator: dorzolamide hydrochloridedorzolamide hydrochloride 1%, 8-week	Drug	2

Primary outcome

Change in Intraocular Pressure (IOP) From Baseline at 8 Weeks
Time frame: 8 weeks
Change from baseline to 8 weeks in Intraocular Pressure (IOP) assessed 2 hours after ocular instillation (at Hour 2)

2 secondary outcomes

Percent Change From Baseline in Intraocular Pressure (IOP) at 8 Weeks
Time frame: 8 Weeks
Percent Change From Baseline in Outflow Pressure Reduction Rate at 8 Weeks
Time frame: 8 weeks

Results and safety

Results posted to the registry on 29 May 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
MK0507A (Dorzolamide 1.0% / Timolol 0.5% Combination)	189	179
Timolol 0.5%	92	88
Concomitant (Dorzolamide 1.0% / Timolol 0.5%)	193	184

Primary outcome: Change in Intraocular Pressure (IOP) From Baseline at 8 Weeks

Time frame: 8 weeks. Least squares mean (95% Confidence Interval). Unit: mmHg

Measure	MK0507A (Dorzolamide 1.0% / Timolol 0.5% Combination) n = 185	Timolol 0.5% n = 90	Concomitant (Dorzolamide 1.0% / Timolol 0.5%) n = 188
Value	-2.50 (-2.86 to -2.15)	-1.82 (-2.33 to -1.31)	-2.78 (-3.13 to -2.43)

MK0507A (Dorzolamide 1.0% / Timolol 0.5% Combination) vs Timolol 0.5%: Mean Difference (Final Values): -0.68 (95% CI -1.30 to -0.06)
MK0507A (Dorzolamide 1.0% / Timolol 0.5% Combination) vs Concomitant (Dorzolamide 1.0% / Timolol 0.5%): Mean Difference (Final Values): 0.28 (95% CI -0.22 to 0.78)

Population analysed: Last observed value during the 8-week treatment period was used in the Full Analysis Set (FAS).

2 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 2% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
MK0507A (Dorzolamide 1.0% / Timolol 0.5% Combination)	2 of ?	36 of ?	Not reported
Timolol 0.5%	1 of ?	12 of ?	Not reported
Concomitant (Dorzolamide 1.0% / Timolol 0.5%)	0 of ?	40 of ?	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 20 Jun 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 21735753Kitazawa Y, Araie M; Research Group on MK-0507A. [Double-masked, phase III comparative study of the combination ophthalmic solution of the 1% dorzolamide hydrochloride/0.5% timolol maleate (MK-0507A) in patients with glaucoma and ocular hypertension]. Nippon Ganka Gakkai Zasshi. 2011 Jun;115(6):495-507. Japanese.
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

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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 dorzolamide hydrochloride (+) timolol maleate, Comparator: timolol maleate and Comparator: dorzolamide hydrochloride in people with Glaucoma, 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 1 inclusion and 2 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 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 29 May 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?

Change in Intraocular Pressure (IOP) From Baseline at 8 Weeks (time frame: 8 weeks). 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 NCT00449956, 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 Jun 2017.