Effect of Myocilin Genetic Variants on Intraocular Pressure and Pressure Variation in Sitting and Supine Positions (Myoc Gene)
Recruitment status was Recruiting
| Tracking Information | |||||||||
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| First Received Date ICMJE | May 19, 2009 | ||||||||
| Last Updated Date | May 22, 2009 | ||||||||
| Start Date ICMJE | May 2009 | ||||||||
| Estimated Primary Completion Date | July 2010 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
To determine if the myocilin gene which can cause glaucoma affects eye and blood pressure changes in sitting and supine positions with and without glaucoma drug (Cosopt eyedrop specifically) treatment. [ Time Frame: 10 weeks ] [ Designated as safety issue: No ] | ||||||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | Complete list of historical versions of study NCT00906087 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE |
Blood pressure and eye pressure changes with and without treatment in sitting and supine positions [ Time Frame: 10 week study ] [ Designated as safety issue: No ] | ||||||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Effect of Myocilin Genetic Variants on Intraocular Pressure and Pressure Variation in Sitting and Supine Positions | ||||||||
| Official Title ICMJE | The Effect of Myocilin Genetic Variants on Intraocular Pressure and Blood Pressure Variation in Sitting and Supine Positions. | ||||||||
| Brief Summary | The purpose of this study is to determine if one of the genes that can cause glaucoma, called myocilin, are associated with larger eye pressure and blood pressure changes in sitting and lying down positions without glaucoma drug treatment and with glaucoma drug treatment with a combination medication called Cosopt® (Merck & Co., Inc.). |
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| Detailed Description | Glaucoma is an important public health issue, and identifying new markers to improve treatment outcomes is a high priority. Progress in Mendelian genetic approaches has led to identifying 15 genes and 31 loci (http://www.ncbi.nlm.nih.gov/); however, since these monogenic forms of glaucoma are uncommon, other approaches are needed to identify genetic markers that contribute to common risk factors, such as elevated IOP, IOP fluctuation, and drug response variation. It is well known that IOP varies over a 24-hour period,1-6 but the mechanisms that regulate this IOP rhythm are not yet fully known. Drance reported that 84% of normal eyes (N=320 eyes) had IOP fluctuations of less than 5 mmHg in contrast to only 6% of untreated glaucomatous eyes (N=138).7 Drance clearly recognized that IOP factors were more variable in eyes with glaucoma. Attention to this IOP fluctuation during glaucoma treatment is important because fluctuation leads to progression. The variation in IOP drug response profiles measured at selected times over a 24-hour period is related to the mechanism of action of these drugs, endogenous circadian rhythms, and glaucoma. We now have the molecular and genomic tools to identify potential genetic markers for these variable traits. Advancing clinical research to the "translational" level is an important step to integrate our ever increasing knowledge base in genomics and proteinomics with clinical trials and clinical studies. Given the infrastructure at the University of Michigan with the strength in both glaucoma genetics and our resources in the clinic, we are well-positioned to conduct such translational research in glaucoma. Although it is known that myocilin (MYOC) mutations cause the phenotype of high pressure open-angle glaucoma (OAG), the effect of these MYOC mutations in "pre-symptomatic" subjects and patients with early OAG on IOP variation is not known. |
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| Study Type ICMJE | Interventional | ||||||||
| Study Phase | Phase 4 | ||||||||
| Study Design ICMJE | Endpoint Classification: Pharmacokinetics Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Basic Science |
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| Condition ICMJE | Glaucoma | ||||||||
| Intervention ICMJE | Drug: Cosopt (combination eyedrop of dorzolamide and timolol)
One drop in each eye every twelve hours for six weeks |
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| Study Arm (s) | Not Provided | ||||||||
| Publications * | Not Provided | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE | 20 | ||||||||
| Estimated Completion Date | July 2010 | ||||||||
| Estimated Primary Completion Date | July 2010 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 18 Years and older | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | United States | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT00906087 | ||||||||
| Other Study ID Numbers ICMJE | Merck IISP#31911, Merck IISP#31911 | ||||||||
| Has Data Monitoring Committee | Yes | ||||||||
| Responsible Party | Sayoko Moroi, MD, PhD, University of Michigan Department of Ophthalmology and Visual Science | ||||||||
| Study Sponsor ICMJE | University of Michigan | ||||||||
| Collaborators ICMJE | Merck | ||||||||
| Investigators ICMJE |
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| Information Provided By | University of Michigan | ||||||||
| Verification Date | May 2009 | ||||||||
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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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