Effect of Myocilin Genetic Variants on Intraocular Pressure and Pressure Variation in Sitting and Supine Positions

• Status: Completed
• Trial end date: 2012-07-18
• Target enrollment: 0
• Participant gender: All

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.).

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Michigan
• Collaborator: Merck Sharp & Dohme Corp.
• Treatments: Dorzolamide; Ophthalmic Solutions; Tetrahydrozoline; Timolol

Criteria

Inclusion Criteria:

• 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

• 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

Exclusion Criteria:

• 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

• 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