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| ID | Type | Description | Link |
|---|---|---|---|
| MK0507A-149 | |||
| 2007_011 |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | combination of dorzolamide hydrochloride and timolol maleate |
|
| 2 | Active Comparator | Concomitant use of dorzolamide hydrochloride and timolol maleate |
|
| 3 | Active Comparator | timolol maleate |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| dorzolamide hydrochloride (+) timolol maleate | Drug | Dorzolamide hydrochloride 1% + timolol 0.5%, 8-week |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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) | 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | 8 Weeks |
| Percent Change From Baseline in Outflow Pressure Reduction Rate at 8 Weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Monitor | Merck Sharp & Dohme LLC | Study Director |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21735753 | Result | 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. |
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Outpatients with primary open angle glaucoma (broad definition) and/or ocular hypertension received 4-week timolol 0.5% monotherapy in the wash-out period before the study randomization.
Phase III.
Studied period: April 9, 2007 (date study therapy started for the first subject) to February 16, 2008 (the last subject's last visit stipulated in study protocol). Study was conducted at 67 clinical sites.
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| ID | Title | Description |
|---|---|---|
| FG000 | MK0507A (Dorzolamide 1.0% / Timolol 0.5% Combination) | MK0507A (Dorzolamide 1.0% / Timolol 0.5% combination), one drop per dose twice daily to the study eye. |
| FG001 | Timolol 0.5% | Timolol 0.5%, one drop per dose twice daily to the study eye. |
| FG002 | Concomitant (Dorzolamide 1.0% / Timolol 0.5%) | Concomitant (Dorzolamide 1.0%, one drop per dose three times daily to the study eye / Timolol 0.5%, one drop per dose twice daily to the study eye). |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | MK0507A (Dorzolamide 1.0% / Timolol 0.5% Combination) | MK0507A (Dorzolamide 1.0% / Timolol 0.5% combination), one drop per dose twice daily to the study eye. |
| BG001 | Timolol 0.5% |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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) | Last observed value during the 8-week treatment period was used in the Full Analysis Set (FAS). | Posted | Least Squares Mean | 95% Confidence Interval | mmHg | 8 weeks |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | MK0507A (Dorzolamide 1.0% / Timolol 0.5% Combination) | MK0507A (Dorzolamide 1.0% / Timolol 0.5% combination), one drop per dose twice daily to the study eye. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Arteriosclerosis obliterans | Vascular disorders | MedDRA 10.1 | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Conjunctival hyperaemia | Eye disorders | MedDRA 10.1 | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Vice President, Global Clinical Development | Merck Sharp & Dohme Corp | 1-800-672-6372 |
| ID | Term |
|---|---|
| D005901 | Glaucoma |
| ID | Term |
|---|---|
| D009798 | Ocular Hypertension |
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| C479140 | dorzolamide-timolol combination |
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| Comparator: timolol maleate | Drug | timolol maleate 0.5%, 8-week |
|
| Comparator: dorzolamide hydrochloride | Drug | dorzolamide hydrochloride 1%, 8-week |
|
Percent Change from baseline to 8 weeks in Outflow Pressure Reduction Rate assessed 2 hours after ocular instillation (at Hour 2) |
| 8 weeks |
| Protocol Violation |
|
| Withdrawal by Subject |
|
| Physician Decision |
|
Timolol 0.5%, one drop per dose twice daily to the study eye.
| BG002 | Concomitant (Dorzolamide 1.0% / Timolol 0.5%) | Concomitant (Dorzolamide 1.0%, one drop per dose three times daily to the study eye / Timolol 0.5%, one drop per dose twice daily to the study eye). |
| BG003 | Total | Total of all reporting groups |
| Years |
|
| Age, Customized | Number | participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Diagnosis | Number | participants |
|
| Intraocular pressure (IOP) at Hour 2 | Mean | Standard Deviation | mmHg |
|
| OG002 | Concomitant (Dorzolamide 1.0% / Timolol 0.5%) | Concomitant (Dorzolamide 1.0%, one drop per dose three times daily to the study eye / Timolol 0.5%, one drop per dose twice daily to the study eye). |
|
|
|
| Secondary | 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) | Last observed value during the 8-week treatment period was used in the FAS. | Posted | Least Squares Mean | 95% Confidence Interval | Percent Change | 8 Weeks |
|
|
|
| Secondary | 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) | Last observed value during the 8-week treatment period was used in the FAS. | Posted | Least Squares Mean | 95% Confidence Interval | Percent Change | 8 weeks |
|
|
|
| 2 |
| 36 |
| EG001 | Timolol 0.5% | Timolol 0.5%, one drop per dose twice daily to the study eye. | 1 | 12 |
| EG002 | Concomitant (Dorzolamide 1.0% / Timolol 0.5%) | Concomitant (Dorzolamide 1.0%, one drop per dose three times daily to the study eye / Timolol 0.5%, one drop per dose twice daily to the study eye). | 0 | 40 |
| Forearm fracture | Injury, poisoning and procedural complications | MedDRA 10.1 | Non-systematic Assessment |
|
| Cerebral infarction | Nervous system disorders | MedDRA 10.1 | Non-systematic Assessment |
|
| Corneal epithelium defect | Eye disorders | MedDRA 10.1 | Non-systematic Assessment |
|
| Punctate keratitis | Eye disorders | MedDRA 10.1 | Non-systematic Assessment |
|
| Instillation site irritation | General disorders | MedDRA 10.1 | Non-systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA 10.1 | Non-systematic Assessment |
|
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA 10.1 | Non-systematic Assessment |
|
| Lumbar spinal stenosis | Musculoskeletal and connective tissue disorders | MedDRA 10.1 | Non-systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 10.1 | Non-systematic Assessment |
|
| Alanine aminotransferase increased | Investigations | MedDRA 10.1 | Non-systematic Assessment |
|
| Glucose urine present | Investigations | MedDRA 10.1 | Non-systematic Assessment |
|
| Blood urine present | Investigations | MedDRA 10.1 | Non-systematic Assessment |
|
Merck agreements may vary with individual investigators, but will not prohibit any investigator from publishing. Merck supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.