Trial · NCT00449956
MK0507A Clinical Study in Patients With Glaucoma and Ocular Hypertension (0507A-149)(COMPLETED)
NCT00449956, Phase 3, Completed, Merck Sharp & Dohme LLC; results first posted 2009-05-29
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. MK0507A Clinical Study in Patients With Glaucoma and Ocular Hypertension (0507A-149)(COMPLETED). Trials, record NCT00449956. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00449956
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- MK0507A Clinical Study in Patients With Glaucoma and Ocular Hypertension (0507A-149)(COMPLETED)
- NCT number
- NCT00449956
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 474 participants, actual
- Lead sponsor
- Merck Sharp & Dohme LLC
- Conditions
- Glaucoma
- Interventions
- dorzolamide hydrochloride (+) timolol maleate, Comparator: timolol maleate, Comparator: dorzolamide hydrochloride
- First posted
- 2007-03-21
- Last updated
- 2017-06-20
- Results first posted
- 2009-05-29
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change in Intraocular Pressure (IOP) From Baseline at 8 Weeks | 8 weeks | Change from baseline to 8 weeks in Intraocular Pressure (IOP) assessed 2 hours after ocular instillation (at Hour 2) |
| Secondary | Percent Change From Baseline in Intraocular Pressure (IOP) at 8 Weeks | 8 Weeks | Percent Change from baseline to 8 weeks in Intraocular Pressure (IOP) assessed 2 hours after ocular instillation (at Hour 2) |
| Secondary | Percent Change From Baseline in Outflow Pressure Reduction Rate at 8 Weeks | 8 weeks | Percent Change from baseline to 8 weeks in Outflow Pressure Reduction Rate assessed 2 hours after ocular instillation (at Hour 2) |
Source ClinicalTrials.gov
Outcomes3
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change in Intraocular Pressure (IOP) From Baseline at 8 Weeks | 8 weeks | Last observed value during the 8-week treatment period was used in the Full Analysis Set (FAS). | mmHg | LEAST_SQUARES_MEAN |
| SECONDARY | Percent Change From Baseline in Intraocular Pressure (IOP) at 8 Weeks | 8 Weeks | Last observed value during the 8-week treatment period was used in the FAS. | Percent Change | LEAST_SQUARES_MEAN |
| SECONDARY | Percent Change From Baseline in Outflow Pressure Reduction Rate at 8 Weeks | 8 weeks | Last observed value during the 8-week treatment period was used in the FAS. | Percent Change | LEAST_SQUARES_MEAN |
Source ClinicalTrials.gov
Results by group9
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change in Intraocular Pressure (IOP) From Baseline at 8 Weeks | MK0507A (Dorzolamide 1.0% / Timolol 0.5% Combination) | -2.50 | 95% Confidence Interval -2.86 to -2.15 | mmHg | |
| Change in Intraocular Pressure (IOP) From Baseline at 8 Weeks | Timolol 0.5% | -1.82 | 95% Confidence Interval -2.33 to -1.31 | mmHg | |
| Change in Intraocular Pressure (IOP) From Baseline at 8 Weeks | Concomitant (Dorzolamide 1.0% / Timolol 0.5%) | -2.78 | 95% Confidence Interval -3.13 to -2.43 | mmHg | |
| Percent Change From Baseline in Intraocular Pressure (IOP) at 8 Weeks | MK0507A (Dorzolamide 1.0% / Timolol 0.5% Combination) | -11.99 | 95% Confidence Interval -13.69 to -10.28 | Percent Change | |
| Percent Change From Baseline in Intraocular Pressure (IOP) at 8 Weeks | Timolol 0.5% | -8.74 | 95% Confidence Interval -11.18 to -6.30 | Percent Change | |
| Percent Change From Baseline in Intraocular Pressure (IOP) at 8 Weeks | Concomitant (Dorzolamide 1.0% / Timolol 0.5%) | -13.46 | 95% Confidence Interval -15.15 to -11.77 | Percent Change | |
| Percent Change From Baseline in Outflow Pressure Reduction Rate at 8 Weeks | MK0507A (Dorzolamide 1.0% / Timolol 0.5% Combination) | 23.47 | 95% Confidence Interval 20.07 to 26.88 | Percent Change | |
| Percent Change From Baseline in Outflow Pressure Reduction Rate at 8 Weeks | Timolol 0.5% | 17.17 | 95% Confidence Interval 12.29 to 22.05 | Percent Change | |
| Percent Change From Baseline in Outflow Pressure Reduction Rate at 8 Weeks | Concomitant (Dorzolamide 1.0% / Timolol 0.5%) | 26.75 | 95% Confidence Interval 23.37 to 30.12 | Percent Change |
Source ClinicalTrials.gov
Participant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | MK0507A (Dorzolamide 1.0% / Timolol 0.5% Combination) | 189 | |
| Overall Study | STARTED | Timolol 0.5% | 92 | |
| Overall Study | STARTED | Concomitant (Dorzolamide 1.0% / Timolol 0.5%) | 193 | |
| Overall Study | COMPLETED | MK0507A (Dorzolamide 1.0% / Timolol 0.5% Combination) | 179 | |
| Overall Study | COMPLETED | Timolol 0.5% | 88 | |
| Overall Study | COMPLETED | Concomitant (Dorzolamide 1.0% / Timolol 0.5%) | 184 | |
| Overall Study | NOT COMPLETED | MK0507A (Dorzolamide 1.0% / Timolol 0.5% Combination) | 10 | |
| Overall Study | NOT COMPLETED | Timolol 0.5% | 4 | |
| Overall Study | NOT COMPLETED | Concomitant (Dorzolamide 1.0% / Timolol 0.5%) | 9 |
Source ClinicalTrials.gov
Adverse events42
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Conjunctival hyperaemia | Eye disorders | MK0507A (Dorzolamide 1.0% / Timolol 0.5% Combination) | 3 | 189 | |
| other | Conjunctival hyperaemia | Eye disorders | Timolol 0.5% | 1 | 92 | |
| other | Conjunctival hyperaemia | Eye disorders | Concomitant (Dorzolamide 1.0% / Timolol 0.5%) | 4 | 193 | |
| other | Corneal epithelium defect | Eye disorders | MK0507A (Dorzolamide 1.0% / Timolol 0.5% Combination) | 2 | 189 | |
| other | Corneal epithelium defect | Eye disorders | Timolol 0.5% | 2 | 92 | |
| other | Corneal epithelium defect | Eye disorders | Concomitant (Dorzolamide 1.0% / Timolol 0.5%) | 5 | 193 | |
| other | Punctate keratitis | Eye disorders | MK0507A (Dorzolamide 1.0% / Timolol 0.5% Combination) | 3 | 189 | |
| other | Punctate keratitis | Eye disorders | Timolol 0.5% | 0 | 92 | |
| other | Punctate keratitis | Eye disorders | Concomitant (Dorzolamide 1.0% / Timolol 0.5%) | 6 | 193 | |
| other | Instillation site irritation | General disorders | MK0507A (Dorzolamide 1.0% / Timolol 0.5% Combination) | 13 | 189 |
1 to 10 of 42Source ClinicalTrials.gov
See all 42 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | MK0507A (Dorzolamide 1.0% / Timolol 0.5% Combination) | ||
| Total, all-cause mortality | Timolol 0.5% | ||
| Total, all-cause mortality | Concomitant (Dorzolamide 1.0% / Timolol 0.5%) | ||
| Total, other adverse events | MK0507A (Dorzolamide 1.0% / Timolol 0.5% Combination) | 36 | |
| Total, other adverse events | Timolol 0.5% | 12 | |
| Total, other adverse events | Concomitant (Dorzolamide 1.0% / Timolol 0.5%) | 40 | |
| Total, serious adverse events | MK0507A (Dorzolamide 1.0% / Timolol 0.5% Combination) | 2 | |
| Total, serious adverse events | Timolol 0.5% | 1 | |
| Total, serious adverse events | Concomitant (Dorzolamide 1.0% / Timolol 0.5%) | 0 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 21735753 | RESULT |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00449956
GET https://conductscience.org/api/trials/v1/NCT00449956/events?page=2