GlaucomaPhase 4Myoc GeneNCT00906087
Effect of Myocilin Genetic Variants on Intraocular Pressure and Pressure Variation in Sitting and Supine Positions
A Phase 4 study testing Cosopt (combination eyedrop of dorzolamide and timolol) in people with Glaucoma, run by University of Michigan at 1 site in United States.
Trial 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®… Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Glaucoma
- What is being tested?
- Cosopt (combination eyedrop of dorzolamide and timolol)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Aug 2009to 18 Jul 2012
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Early OAG, as determined by a comprehensive ophthalmic examination
- Greater than or equal to 18 years of age
- Either gender
- Any race
- Both eyes meet eligibility criteria
- Cup to disc ratio less than 0.8 determined by fundoscopy and confirmed by disc photos
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- Visual field parameters in the study eye: Pattern Standard Deviation (PSD) greater than 1.0 dB but less than 6.0 dB
- Ability to cooperate for an outpatient study involving at least five visits over a four month study period
- Ability to comply with Cosopt treatment regimen
Who cannot join
- Less than or equal to 18 years old
- Refusal to be genotyped or sign Informed Consent for Protocol 1991-144
- Pregnant or lactating women
- Medical conditions of severe pulmonary compromise with asthma or emphysema or cardiac contraindications to beta-blockers
- Ocular disease of chronic angle-closure glaucoma, iridocorneal endothelial disease, posterior polymorphous corneal dystrophy, epithelial downgrowth, uveitic glaucoma, or neovascular glaucoma
- Ocular surgery for glaucoma, including trabeculectomy, other glaucoma filtration surgery, glaucoma drainage implant, or laser cyclophotocoagulation
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- Current use of systemic steroids or chemotherapeutic agents that non-selectively inhibit dividing cells
- Proliferative diabetic retinopathy, history of panretinal photocoagulation treatment, diabetic macular edema, or history of macular grid laser treatment
- History of changing treatment involving the use oral beta-blockers, angiotensin converting enzyme inhibitors, calcium channel blockers, or oral alpha 2-agonists in the prior two months or in the next month (i.e., must be on stable treatment with any of these drugs for at least two months)
- Patients taking erectile dysfunction drugs (i.e., Viagra, Cialis, Levitra)
- Contradictions:
- bronchial asthma or a history of bronchial asthma
- severe chronic obstructive pulmonary disease
- sinus bradycardia
- second or third degree atrioventricular block
- overt cardiac failure
- cardiogenic shock
- hypersensitivity to any component of Cosopt
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Myocilin Genetic Variants on Intraocular Pressure and Blood Pressure Variation in Sitting and Supine Positions.
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.).
Read the 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 eye pressure, eye pressure fluctuation, and drug response variation.
It is well known that eye pressure varies over a 24-hour period,1-6 but the mechanisms that regulate this eye pressure rhythm are not yet fully known. Drance reported that 84% of normal eyes (N=320 eyes) had eye pressure fluctuations of less than 5 mmHg in contrast to only 6% of untreated glaucomatous eyes (N=138).7 Drance clearly recognized that eye pressure factors were more variable in eyes with glaucoma. Attention to this eye pressure fluctuation during glaucoma treatment is important because fluctuation leads to progression. The variation in eye pressure 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. The molecular and genetic tools are now available 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, it is possible to test for relationships between glaucoma genes and eye pressure. Although it is known that myocilin (MYOC) mutations cause the phenotype of high pressure open-angle glaucoma, the effect of these MYOC mutations in "pre-symptomatic" subjects and patients with early open-angle glaucoma on eye pressure variation is not known.
- Conditions
- Glaucoma
- Being tested
- Cosopt (combination eyedrop of dorzolamide and timolol)
- Keywords
- Myocilin gene, Glaucoma, dorzolamide and timolol combination eyedrop
- Medical subject headings
- Glaucoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cosopt (combination eyedrop of dorzolamide and timolol)Drug
Also called Cosopt
One drop in each eye every twelve hours for six weeks
| Study group | Role | What they receive |
|---|---|---|
| Cosopt | Other | Intraocular pressure and blood pressure measurements will be compared under the following conditions: 1) after washout of clinical treatment, 2) after treatment with Cosopt, and 3) after another washout of Cosopt. Receives: Drug: Cosopt (combination eyedrop of dorzolamide and timolol) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intraocular Pressure in Sitting and Supine Positions.
Effect of Cosopt treatment on intraocular pressure changes in sitting to supine positions.
Measured: 10 weeks
Blood Pressure in Sitting to Supine Positions
Effect of Cosopt treatment on blood pressure changes in sitting to supine positions.
Measured: 10 weeks
Secondary outcomes (1)
Myocilin Mutation Arg272Gly in Subjects
Number of subjects with Myocilin Arg272Gly
Measured: 10 week study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2009 (estimated)
- Study start4 Aug 2009
- Primary completion18 Jul 2012
- Study completion18 Jul 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for GlaucomaStudies of the same condition, open and under way.
- More trials run by University of MichiganThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Responsible party
- Principal investigator, Sayoko E. Moroi, University of Michigan
- Investigators
- Sayoko E Moroi, MD, PhD, Principal investigator, University of Michigan Department of Ophthalmology and Visual Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00906087
- Sponsor's protocol ID
- Merck IISP#31911
- Other IDs
- Merck IISP#31911
- Acronym
- Myoc Gene
- Status last verified
- May 2017
- First submitted
- 19 May 2009
- Last updated
- 2 Jun 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Myocilin Genetic Variants on Intraocular Pressure and Blood Pressure Variation in Sitting and Supine Positions.
- ClinicalTrials.gov ID
- NCT00906087
- Acronym / sponsor ID
- Myoc Gene / Merck IISP#31911
- Conditions
- Glaucoma
- Keywords
- Myocilin gene, Glaucoma, dorzolamide and timolol combination eyedrop
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Study start
- 4 Aug 2009 (actual)
- Primary completion
- 18 Jul 2012 (actual)
- Study completion
- 18 Jul 2012 (actual)
- First posted
- 21 May 2009 (estimated)
- Results
- Posted 2 Jun 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.).
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 eye pressure, eye pressure fluctuation, and drug response variation.
It is well known that eye pressure varies over a 24-hour period,1-6 but the mechanisms that regulate this eye pressure rhythm are not yet fully known. Drance reported that 84% of normal eyes (N=320 eyes) had eye pressure fluctuations of less than 5 mmHg in contrast to only 6% of untreated glaucomatous eyes (N=138).7 Drance clearly recognized that eye pressure factors were more variable in eyes with glaucoma. Attention to this eye pressure fluctuation during glaucoma treatment is important because fluctuation leads to progression. The variation in eye pressure 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. The molecular and genetic tools are now available 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, it is possible to test for relationships between glaucoma genes and eye pressure. Although it is known that myocilin (MYOC) mutations cause the phenotype of high pressure open-angle glaucoma, the effect of these MYOC mutations in "pre-symptomatic" subjects and patients with early open-angle glaucoma on eye pressure variation is not known.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cosopt | Other | Drug: Cosopt (combination eyedrop of dorzolamide and timolol)Intraocular pressure and blood pressure measurements will be compared under the following conditions: 1) after washout of clinical treatment, 2) after treatment with Cosopt, and 3) after another washout of Cosopt. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Early OAG, as determined by a comprehensive ophthalmic examination
- Greater than or equal to 18 years of age
- Either gender
- Any race
- Both eyes meet eligibility criteria
Key exclusion criteria (18 listed)
- Less than or equal to 18 years old
- Refusal to be genotyped or sign Informed Consent for Protocol 1991-144
- Pregnant or lactating women
- Medical conditions of severe pulmonary compromise with asthma or emphysema or cardiac contraindications to beta-blockers
- Ocular disease of chronic angle-closure glaucoma, iridocorneal endothelial disease, posterior polymorphous corneal dystrophy, epithelial downgrowth, uveitic glaucoma, or neovascular glaucoma
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cosopt (combination eyedrop of dorzolamide and timolol)Also: CosoptOne drop in each eye every twelve hours for six weeks | Drug | Cosopt |
Primary outcome
Intraocular Pressure in Sitting and Supine Positions.
Time frame: 10 weeks
Effect of Cosopt treatment on intraocular pressure changes in sitting to supine positions.
Blood Pressure in Sitting to Supine Positions
Time frame: 10 weeks
Effect of Cosopt treatment on blood pressure changes in sitting to supine positions.
1 secondary outcome
Myocilin Mutation Arg272Gly in Subjects
Time frame: 10 week study
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sayoko E Moroi, MD, PhD principal investigator
University of Michigan Department of Ophthalmology and Visual Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Cosopt (combination eyedrop of dorzolamide and timolol) in people with Glaucoma, run by University of Michigan at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 2 Jun 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intraocular Pressure in Sitting and Supine Positions. (time frame: 10 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jun 2017.