GlaucomaPhase 3NCT00108017
Comparison of the Effects of Two Glaucoma Drugs Over 24 Hours (0507A-137)(COMPLETED)
A Phase 3 study testing MK0507A, dorzolamide hydrochloride (+) timolol maleate, Comparator: timolol maleate and Duration of Treatment: Part 1) 6 wk timolol maleate run in in people with Glaucoma and Ocular Hypertension, run by Merck Sharp & Dohme LLC.
Trial summary
This study is comparing 2 medications for glaucoma and how effective they are at controlling glaucoma over the course of an entire day. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Glaucoma, Ocular Hypertension
- What is being tested?
- MK0507A, dorzolamide hydrochloride (+) timolol maleate, Comparator: timolol maleate and Duration of Treatment: Part 1) 6 wk timolol maleate run in
- How many people
- 330 participants
- Where
- No sites listed yet
- Study dates
- Apr 2005to Jul 2006
- 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
- Patients with glaucoma or ocular hypertension
Who cannot join
- Other eye conditions
- Poor vision
- Recent eye surgery
- Use of contact lenses
- Nursing or pregnant women
- Use of some other selected medications
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- Drug or alcohol abuse
- Asthma
- Slow heart beat
- Allergy or previous reaction to study drugs
About this study
Official title: Randomized, Multicenter, Dbl-Masked, Parallel Study Evaluating the 24 Hr. Diurnal Ocular Hypotensive Effect of 2% Dorzolamide Hydrochloride/0.5% Timolol Maleate Combo. Ophthalmic Sol. in Patients w/ Open Angle Glaucoma or Ocular Hypertension
This study is comparing 2 medications for glaucoma and how effective they are at controlling glaucoma over the course of an entire day.
- Conditions
- Glaucoma, Ocular Hypertension
- Being tested
- MK0507A, dorzolamide hydrochloride (+) timolol maleate, Comparator: timolol maleate, Duration of Treatment: Part 1) 6 wk timolol maleate run in, Part 2) 6 wk washout pd Part 3) two 8 wk active tx pds
- Keywords
- Ocular hypertension (excessive pressure in the eye)
- Medical subject headings
- Glaucoma, Ocular Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MK0507A, dorzolamide hydrochloride (+) timolol maleateDrug
Comparator: timolol maleateDrug
Duration of Treatment: Part 1) 6 wk timolol maleate run inDrug
Part 2) 6 wk washout pd Part 3) two 8 wk active tx pdsDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
24 hour diurnal IOP reduction after 8 weeks of treatment
Measured: After 8 weeks of treatment
Secondary outcomes (1)
IOP reduction a) from baseline at 6 weeks; b) comparison with timolol; c) comparison day versus night
Measured: At 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2005 (estimated)
- Study startApr 2005
- Primary completionJul 2006
- Study completionJul 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 330 participants (actual)
Sponsor and investigators
- Lead sponsor
- Merck Sharp & Dohme LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Monitor, Study director, Merck Sharp & Dohme LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00108017
- Sponsor's protocol ID
- 0507A-137
- Other IDs
- 2005_021
- Status last verified
- May 2015
- First submitted
- 12 Apr 2005
- Last updated
- 13 May 2015
- Results posted
- No
Publications
Feldman RM, Stewart RH, Stewart WC, Jia G, Smugar SS, Galet VA. 24-hour control of intraocular pressure with 2% dorzolamide/0.5% timolol fixed-combination ophthalmic solution in open-angle glaucoma. Curr Med Res Opin. 2008 Aug;24(8):2403-12. doi: 10.1185/03007990802243366. Epub 2008 Jul 14.
PubMed 18627642Olander KW, Galet VA, Jia G, Smugar SS, Stewart WC. Relationship between visual field severity and response to fixed combination dorzolamide/timolol or timolol alone. J Ocul Pharmacol Ther. 2009 Aug;25(4):357-64. doi: 10.1089/jop.2008.0104.
PubMed 19441888
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Multicenter, Dbl-Masked, Parallel Study Evaluating the 24 Hr. Diurnal Ocular Hypotensive Effect of 2% Dorzolamide Hydrochloride/0.5% Timolol Maleate Combo. Ophthalmic Sol. in Patients w/ Open Angle Glaucoma or Ocular Hypertension
- ClinicalTrials.gov ID
- NCT00108017
- Acronym / sponsor ID
- 0507A-137
- Conditions
- Glaucoma, Ocular Hypertension
- Keywords
- Ocular hypertension (excessive pressure in the eye)
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 330 participants (actual)
- Lead sponsor
- Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
- Study start
- Apr 2005
- Primary completion
- Jul 2006 (actual)
- Study completion
- Jul 2006 (actual)
- First posted
- 13 Apr 2005 (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 is comparing 2 medications for glaucoma and how effective they are at controlling glaucoma over the course of an entire day.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with glaucoma or ocular hypertension
Key exclusion criteria (10 listed)
- Other eye conditions
- Poor vision
- Recent eye surgery
- Use of contact lenses
- Nursing or pregnant women
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 |
|---|---|---|
| MK0507A, dorzolamide hydrochloride (+) timolol maleate | Drug | – |
| Comparator: timolol maleate | Drug | – |
| Duration of Treatment: Part 1) 6 wk timolol maleate run in | Drug | – |
| Part 2) 6 wk washout pd Part 3) two 8 wk active tx pds | Drug | – |
Primary outcome
24 hour diurnal IOP reduction after 8 weeks of treatment
Time frame: After 8 weeks of treatment
1 secondary outcome
IOP reduction a) from baseline at 6 weeks; b) comparison with timolol; c) comparison day versus night
Time frame: At 6 weeks
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 13 May 2015.
- Background: PubMed 18627642Feldman RM, Stewart RH, Stewart WC, Jia G, Smugar SS, Galet VA. 24-hour control of intraocular pressure with 2% dorzolamide/0.5% timolol fixed-combination ophthalmic solution in open-angle glaucoma. Curr Med Res Opin. 2008 Aug;24(8):2403-12. doi: 10.1185/03007990802243366. Epub 2008 Jul 14.
- Background: PubMed 19441888Olander KW, Galet VA, Jia G, Smugar SS, Stewart WC. Relationship between visual field severity and response to fixed combination dorzolamide/timolol or timolol alone. J Ocul Pharmacol Ther. 2009 Aug;25(4):357-64. doi: 10.1089/jop.2008.0104.
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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 MK0507A, dorzolamide hydrochloride (+) timolol maleate, Comparator: timolol maleate and Duration of Treatment: Part 1) 6 wk timolol maleate run in 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 1 inclusion and 10 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 13 May 2015. 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?
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?
24 hour diurnal IOP reduction after 8 weeks of treatment (time frame: After 8 weeks of treatment). 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 NCT00108017, which also lists 2 linked publications.
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 13 May 2015.