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

Plain-language summary

This study investigates how variants (genetic variations) in the Myocilin (MYOC) gene affect intraocular pressure and its change with body position in patients with open-angle glaucoma, using Cosopt eyedrops. It included patients over 18 with early open-angle glaucoma. It was a Phase 4 study and has been completed.

The summary above is a plain-language rendering of the official record. The original English title is shown for reference.

Trial details

Phase

Phase 4

Status

Completed

Sponsor

University of Michigan

Intervention

Cosopt (combination eyedrop of dorzolamide and timolol)

Start date

8/4/2009

Estimated completion

7/18/2012

Countries

United States

Related genes

Locations

• Ann Arbor, United States

Eligibility criteria

Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine eligibility.

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