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| ID | Type | Description | Link |
|---|---|---|---|
| 2009_524 |
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A study to evaluate the effect of the 12-week treatment with timolol/dorzolamide combination eyedrops (COSOPT) on decrease in intraocular pressure (IOP) at 2 hours after the study drug administration
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Timolol/Dorzolamide | Experimental | Timolol/Dorzolamide, 1 drop, twice daily, for 12 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| timolol/dorzolamide combination | Drug | Timolol/Dorzolamide, 1 drop, twice daily, for 12 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mean Change in the Peak Intraocular Pressure (IOP) Measured Two Hours After Study Drug Administration at Week 12 Compared to Baseline IOP. | The therapeutic goal of normal tension glaucoma treatment includes lowering IOP to prevent progression of damage in optic nerves or vision. In this trial, IOP was measured with the same tonometer throughout the study. A decreased IOP from baseline is considered an improvement. IOP was measured in both eyes and the eye with the higher IOP was used for the participant. | Baseline and 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Change in Trough IOP Measured Right Before Study Drug Administration at Week 12 Compared to Baseline IOP. | The therapeutic goal of normal tension glaucoma treatment includes lowering IOP to prevent progression of damage in optic nerves or vision. In this trial, IOP was measured with the same tonometer throughout the study. A decreased IOP from baseline is considered an improvement. IOP was measured in both eyes and the eye with the higher IOP was used for the participant. |
| Measure | Description | Time Frame |
|---|---|---|
| Baseline IOP | Baseline IOP was measured at ~9 AM of first day of treatment period. IOP was measured in both eyes and the eye with the higher IOP was used for the participant. | Baseline |
Inclusion Criteria:
Exclusion Criteria:
Patients with another type of glaucoma but primary open-angle glaucoma
Patients treated with other glaucoma medications within 6 weeks prior to study participation
Patients with a history of chronic ocular inflammation or recurrent ocular inflammation
Patients using contact lenses
Patients who are allergic to timolol or dorzolamide
Patients with a history of any of the following COSOPT (timolol/dorzolamide combination) contraindications:
Patients with a history of significant ocular trauma or intraocular surgery within 6 months before participating the study, or intraocular laser surgery within 3 months before the participating the study
Patients with a history of a corneal disease
Patients who are using steroid or used the drug for more than 2 weeks within 12 months before participating the study
Pregnant women
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| Name | Affiliation | Role |
|---|---|---|
| Medical Monitor | Merck Sharp & Dohme LLC | Study Director |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23377586 | Result | Kim TW, Kim M, Lee EJ, Jeoung JW, Park KH. Intraocular pressure-lowering efficacy of dorzolamide/timolol fixed combination in normal-tension glaucoma. J Glaucoma. 2014 Jun-Jul;23(5):329-32. doi: 10.1097/IJG.0b013e3182741f4d. |
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44 participants were actually screened. Among them, 7 participants failed in screening (2 participants withdrew and 5 did not meet eligibility criteria). Therefore 37 participants were considered to have enrolled.
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| ID | Title | Description |
|---|---|---|
| FG000 | Timolol/Dorzolamide | Timolol/Dorzolamide, 1 drop, twice daily, for 12 weeks |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Timolol/Dorzolamide | Timolol/Dorzolamide, 1 drop, twice daily, for 12 weeks |
| 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 | Mean Change in the Peak Intraocular Pressure (IOP) Measured Two Hours After Study Drug Administration at Week 12 Compared to Baseline IOP. | The therapeutic goal of normal tension glaucoma treatment includes lowering IOP to prevent progression of damage in optic nerves or vision. In this trial, IOP was measured with the same tonometer throughout the study. A decreased IOP from baseline is considered an improvement. IOP was measured in both eyes and the eye with the higher IOP was used for the participant. | Posted | Mean | Standard Deviation | mmHg | Baseline and 12 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 | Timolol/Dorzolamide | Timolol/Dorzolamide, 1 drop, twice daily, for 12 weeks |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Eye irritation | Eye disorders | MedDRA (13.0) |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Vice President, Global Clinical Development | Merck Sharp & Dohme Corp | 1-800-672-6372 | ClinicalTrialsDisclosure@merck.com |
| 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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| Baseline and 12 weeks |
| Mean Change in IOP 8 Hours After the Study Drug Administration at Week 12 Compared to Baseline IOP | The therapeutic goal of normal tension glaucoma treatment includes lowering IOP to prevent progression of damage in optic nerves or vision. In this trial, IOP was measured with the same tonometer throughout the study. A decreased IOP from baseline is considered an improvement. IOP was measured in both eyes and the eye with the higher IOP was used for the participant. | Baseline and 12 weeks |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Participants |
|
|
|
| Secondary | Mean Change in Trough IOP Measured Right Before Study Drug Administration at Week 12 Compared to Baseline IOP. | The therapeutic goal of normal tension glaucoma treatment includes lowering IOP to prevent progression of damage in optic nerves or vision. In this trial, IOP was measured with the same tonometer throughout the study. A decreased IOP from baseline is considered an improvement. IOP was measured in both eyes and the eye with the higher IOP was used for the participant. | Posted | Mean | Standard Deviation | mmHg | Baseline and 12 weeks |
|
|
|
|
| Secondary | Mean Change in IOP 8 Hours After the Study Drug Administration at Week 12 Compared to Baseline IOP | The therapeutic goal of normal tension glaucoma treatment includes lowering IOP to prevent progression of damage in optic nerves or vision. In this trial, IOP was measured with the same tonometer throughout the study. A decreased IOP from baseline is considered an improvement. IOP was measured in both eyes and the eye with the higher IOP was used for the participant. | Posted | Mean | Standard Deviation | mmHg | Baseline and 12 weeks |
|
|
|
|
| Other Pre-specified | Baseline IOP | Baseline IOP was measured at ~9 AM of first day of treatment period. IOP was measured in both eyes and the eye with the higher IOP was used for the participant. | Posted | Mean | Standard Deviation | mmHg | Baseline |
|
|
|
| 0 |
| 37 |
| 24 |
| 37 |
| Ocular hyperaemia | Eye disorders | MedDRA (13.0) |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (13.0) |
|
| Headache | Nervous system disorders | MedDRA (13.0) |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA (13.0) |
|
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.