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

NCT00906087 | Completed Phase 4 Results DMC

• 1 other identifier: Merck IISP#31911
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

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.).

Conditions

Glaucoma

Keywords

Myocilin gene; Glaucoma; dorzolamide and timolol combination eyedrop

Outcome Measures

Primary Outcomes (2)

• Intraocular Pressure in Sitting and Supine Positions.

  Effect of Cosopt treatment on intraocular pressure changes in sitting to supine positions.

  10 weeks

• Blood Pressure in Sitting to Supine Positions

  Effect of Cosopt treatment on blood pressure changes in sitting to supine positions.

  10 weeks

Secondary Outcomes (1)

• Myocilin Mutation Arg272Gly in Subjects

  10 week study

Study Arms (1)

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.

Drug: Cosopt (combination eyedrop of dorzolamide and timolol)

Interventions

Cosopt (combination eyedrop of dorzolamide and timolol) DRUG

One drop in each eye every twelve hours for six weeks

Also known as: Cosopt

Cosopt

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Michigan: lead
• Merck Sharp & Dohme LLC: collaborator

Study Sites (1)

W.K. Kellogg Eye Center

Ann Arbor, Michigan, 48105, United States

Location

MeSH Terms

Conditions

Glaucoma

Interventions

dorzolamide-timolol combination; Timolol

Condition Hierarchy (Ancestors)

Ocular Hypertension; Eye Diseases

Intervention Hierarchy (Ancestors)

Propanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Propanols; Amines; Thiadiazoles; Thiazoles; Sulfur Compounds; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Morpholines; Oxazines

Results Point of Contact

• Title: Sayoko E. Moroi
• Organization: University of Michigan

smoroi@med.umich.edu

734-763-3732

Study Officials

• Sayoko E Moroi, MD, PhD

  University of Michigan Department of Ophthalmology and Visual Sciences

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: May 19, 2009
• First Posted: May 21, 2009
• Study Start: August 4, 2009
• Primary Completion: July 18, 2012
• Study Completion: July 18, 2012
• Last Updated: June 2, 2017
• Results First Posted: June 2, 2017

Record last verified: 2017-05

Locations

US (1)