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| Tracking Information | |||||
|---|---|---|---|---|---|
| First Received Date ICMJE | February 13, 2008 | ||||
| Last Updated Date | February 13, 2008 | ||||
| Start Date ICMJE | March 2007 | ||||
| Estimated Primary Completion Date | November 2008 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Comparison of the tolerability and effectiveness of Combigan and Cosopt in the treatment of open angle glaucoma or ocular hypertension [ Time Frame: 12 weeks ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | No Changes Posted | ||||
| Current Secondary Outcome Measures ICMJE | |||||
| Original Secondary Outcome Measures ICMJE | |||||
| Descriptive Information | |||||
| Brief Title ICMJE | A Investigator Masked Parallel Comparison of Tolerability of Combigan and Cosopt | ||||
| Official Title ICMJE | A 12- Week Investigator Masked, Parallel Comparison of Tolerability of Combigan and Cosopt in the Treatment of Open Angle Glaucoma or Ocular Hypertension | ||||
| Brief Summary | The objective of this research study is to compare the tolerability and effectiveness of Combigan(brimonidine tartrate/timolol maleate) and Cosopt (dorzolamide hydrochloride)in the treatment of open angle glaucoma or ocular hypertension. |
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| Detailed Description | Patients between the ages of 40 to 90 years of age, that have been diagnosed with open angle glaucoma or ocular hypertension,including pseudo-exfoliation and pigmentary glaucoma with definitive glaucomatous optic disk cupping and/or glaucomatous visual field loss, who have been recieving a stable treatment regime for at least 4 weeks prior to the study initiation, with a Cosopt mono or a Prostaglandin + Cosopt combination are to be included in the study.Patients must have an IOP between 16 and 32 mmHg, with no readings above 35 mmHg at baseline. Patients with any other form of glaucoma other than primary open angle glaucoma, with a gonioscopy measured angle grade of less than 2, with a visual field defect not of glaucomatous origen and previous cyclodestructive procedures will be excluded.The use of ocular non steroidal and anti-inflammatory topical agents which inhibit cyclooxygenase and prostaglandin analog synthesis,the use of glucocorticoid therapy, and hypersensitivity to any of the study components also precludes involvement in the study. Any ocular laser therapy within the past three months, ocular inflammation or infection in the past three months or any history of trauma in the last six months will also exclude enrollment in the study. |
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| Study Phase | |||||
| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Cohort, Cross-Sectional | ||||
| Condition ICMJE |
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| Intervention ICMJE | |||||
| Study Arms / Comparison Groups | |||||
| Publications * | |||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Recruiting | ||||
| Estimated Enrollment ICMJE | 50 | ||||
| Estimated Completion Date | November 2008 | ||||
| Estimated Primary Completion Date | November 2008 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 40 Years to 90 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | |||||
| Location Countries ICMJE | Canada | ||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00621335 | ||||
| Responsible Party | David Yan, Principal Investigator, Ophthalmic Consultants Centres | ||||
| Study ID Numbers ICMJE | CICOM 1010 | ||||
| Study Sponsor ICMJE | DBYAN Medicine Professional Corporation | ||||
| Collaborators ICMJE | Allergan | ||||
| Investigators ICMJE |
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| Information Provided By | DBYAN Medicine Professional Corporation | ||||
| Verification Date | February 2008 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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