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| ID | Type | Description | Link |
|---|---|---|---|
| MK0507A-152 | |||
| 2007_026 |
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To evaluate if preservative free cosopt is well tolerated in patients with Open angle glaucoma (OAG) or Ocular hypertension (OH) with dry eyes.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| dorzolamide hydrochloride (+) timolol maleate | Drug | dorzolamide hydrochloride (2%)/ timolol maleate (0.5%) Preservative free twice a day (BID), for 8 weeks of treatment |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Glaucoma Symptom Scale (GSS)-SYMP-6 Score | GSS-SYMP-6 measures 6 non-visual adverse symptoms related to glaucoma medications, with 10 5-point Likert scale questions. Score ranges between 0 and 100, lower scores indicating higher symptoms severity. Change equals post-baseline value minus baseline. | Baseline to week 8 |
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| Measure | Description | Time Frame |
|---|---|---|
| Patient's Global Satisfaction | At week 8, patients were asked to complete a single question describing how satisfied they were regarding with their medication, on a 5-level scale: very satisfied, satisfied, neither satisfied or dissatisfied, dissatisfied, very dissatisfied. | Week 8 |
| Physician's Global Satisfaction |
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 |
|---|---|---|---|
| 20668720 | Result | Hutnik C, Neima D, Ibrahim F, Scott R, Vaillancourt J, Haine D, Sampalis JS, Bastien N, Foucart S. Tolerability and effectiveness of preservative-free dorzolamide-timolol (preservative-free COSOPT) in patients with open-angle glaucoma or ocular hypertension. Clin Ophthalmol. 2010 Jul 21;4:581-90. doi: 10.2147/opth.s10337. |
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First patient in: MAY-23-2007
Last patient out: OCT-15-2008
Total number of sites: 28 sites in Canada. (Study performed in Canada only).
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| ID | Title | Description |
|---|---|---|
| FG000 | Preservative-free Dorzolamide-timolol (COSOPT®) | subjects received preservative-free dorzolamide-timolol (COSOPT®) administered one drop in the affected eye two times daily The number of patients analyzed (n=176) differs from the initial tables because 2 patients withdrew consent and for whom no data were available at subsequent visits (only baseline characteristircs were available). |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Preservative-free Dorzolamide-timolol (COSOPT®) | subjects received preservative-free dorzolamide-timolol (COSOPT®) administered one drop in the affected eye two times daily The number of patients analyzed (n=176) differs from the initial tables because 2 patients withdrew consent and for whom no data were available at subsequent visits (only baseline characteristircs were available). |
| 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 Glaucoma Symptom Scale (GSS)-SYMP-6 Score | GSS-SYMP-6 measures 6 non-visual adverse symptoms related to glaucoma medications, with 10 5-point Likert scale questions. Score ranges between 0 and 100, lower scores indicating higher symptoms severity. Change equals post-baseline value minus baseline. | 176 patients qualified for inclusion in the intent to treat (ITT) analysis and completed the first visit. Observations on GSS-SYMP-6 were available for 114 and 111 patients at week 4 and 8 respectively | Posted | Mean | Standard Deviation | Units on a Scale | Baseline to week 8 |
|
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As per protocol only Serious Adverse Events were systematically reported.
The 0/0 indicates that Other (Not Including Serious) Adverse Events were not collected as per protocol.
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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 | Preservative-free Dorzolamide-timolol (COSOPT®) | subjects received preservative-free dorzolamide-timolol (COSOPT®) administered one drop in the affected eye two times daily The number of patients analyzed (n=176) differs from the initial tables because 2 patients withdrew consent and for whom no data were available at subsequent visits (only baseline characteristircs were available). |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cardiac disorders | Cardiac disorders | MedDRA 11.1 | 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 |
|---|---|
| D009798 | Ocular Hypertension |
| D005902 | Glaucoma, Open-Angle |
| ID | Term |
|---|---|
| D005128 | Eye Diseases |
| D005901 | Glaucoma |
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| ID | Term |
|---|---|
| C479140 | dorzolamide-timolol combination |
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At week 8, physicians were asked to complete a single question describing how satisfied they were regarding their patient's treatment, on a 5-level scale: very satisfied, satisfied, neither satisfied or dissatisfied, dissatisfied, very dissatisfied. |
| Week 8 |
| Change in Intra-ocular Pressure (IOP) for Worse Eye From Baseline to Week 4 and From Baseline to Week 8, in Patients Receiving Preservative-free Dorzolamide-timolol | IOP measurements using Goldmann applanation tonometry, performed by a masked physician two hours after patient was administered study medication. Change is computed as week 4 (or week 8) value minus baseline value. | Baseline to Week 4 and from Baseline to Week 8 |
| cancel all appointments, no rebooking |
|
| inclement weather |
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| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
|
|
|
| Other Pre-specified | Patient's Global Satisfaction | At week 8, patients were asked to complete a single question describing how satisfied they were regarding with their medication, on a 5-level scale: very satisfied, satisfied, neither satisfied or dissatisfied, dissatisfied, very dissatisfied. | 178 - number of patients that signed the consent form and received at least one dose of study medication. The number of patients analyzed (n=176) differs from the initial tables because 2 patients withdrew consent and for whom no data were available at subsequent visits (only baseline characteristics were available). | Posted | Number | Participants | Week 8 |
|
|
|
| Other Pre-specified | Physician's Global Satisfaction | At week 8, physicians were asked to complete a single question describing how satisfied they were regarding their patient's treatment, on a 5-level scale: very satisfied, satisfied, neither satisfied or dissatisfied, dissatisfied, very dissatisfied. | 178 - number of patients that signed the consent form and received at least one dose of study medication. The number of patients analyzed (n=176) differs from the initial tables because 2 patients withdrew consent and for whom no data were available at subsequent visits (only baseline characteristics were available). | Posted | Number | Participants | Week 8 |
|
|
|
| Other Pre-specified | Change in Intra-ocular Pressure (IOP) for Worse Eye From Baseline to Week 4 and From Baseline to Week 8, in Patients Receiving Preservative-free Dorzolamide-timolol | IOP measurements using Goldmann applanation tonometry, performed by a masked physician two hours after patient was administered study medication. Change is computed as week 4 (or week 8) value minus baseline value. | 176 patients qualified for inclusion in the intent to treat (ITT) analysis and completed the first visit. Observations on IOP were available for 164 and 166 patients at week 4 and 8 respectively | Posted | Mean | Standard Deviation | mm Hg | Baseline to Week 4 and from Baseline to Week 8 |
|
|
|
|
| 3 |
| 178 |
| 0 |
| 0 |
| Gastrointestinal disorders | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
|
| Eye disorders | Eye disorders | MedDRA 11.1 | 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.
| Title | Measurements |
|---|---|
|
| Dissatisfied |
|
| Very Dissatisfied |
|
| Missing |
|
| Title | Measurements |
|---|---|
|
| Dissatisfied |
|
| Very Dissatisfied |
|
| Missing |
|
| t-test, 2 sided |
| <0.001 |
| Median Difference (Net) |
| -11.5 |
| Standard Deviation |
| 5.3 |
| 95 |
| -12.3 |
| -10.7 |
| Superiority or Other |