NCT00906087: Myoc Gene

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

Completed Phase 4 Results posted Last updated 2 June 2017

What this trial tests

Phase 4 trial testing Cosopt (combination eyedrop of dorzolamide and timolol) in Glaucoma in 14 participants. Completed in 18 July 2012.

Timeline

4 August 2009

Primary endpoint
18 July 2012

18 July 2012

Quick facts

Lead sponsor	University of Michigan
Phase	Phase 4
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	basic science
Enrollment	14
Start date	4 August 2009
Primary completion	18 July 2012
Estimated completion	18 July 2012
Sites	1 location across United States

Drugs / interventions tested

• Cosopt (combination eyedrop of dorzolamide and timolol) — full drug profile →

Conditions studied

• Glaucoma — all drugs for Glaucoma →

Sponsor

University of Michigan

Who can join

Adults 18 to 99, any sex, with Glaucoma. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Intraocular Pressure in Sitting and Supine Positions. Primary · 10 weeks

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

Sitting right eye

Group	Value	95% CI
Cosopt	18.5	± 2.94

Sitting left eye

Group	Value	95% CI
Cosopt	19.4	± 3.23

Supine right eye

Group	Value	95% CI
Cosopt	22.2	± 3.06

Supine left eye

Group	Value	95% CI
Cosopt	22.8	± 4.32

Blood Pressure in Sitting to Supine Positions Primary · 10 weeks

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

Sitting systolic blood pressure

Group	Value	95% CI
Cosopt	139.6	± 20.40

Supine systolic blood pressure

Group	Value	95% CI
Cosopt	133.8	± 21.7

Sitting diastolic blood pressure

Group	Value	95% CI
Cosopt	86.8	± 12.29

Supine diastolic blood pressure

Group	Value	95% CI
Cosopt	89.3	± 16.96

Myocilin Mutation Arg272Gly in Subjects Secondary · 10 week study

Number of subjects with Myocilin Arg272Gly

Group	Value	95% CI
Cosopt	1

Adverse events — posted to ClinicalTrials.gov

Time frame: 12 weeks of study participation (2 week washout; 6 weeks on Cosopt; 4 weeks washout). Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Cosopt

Serious: 0/12 (0%)

Deaths: 0/12

Washout (no Glaucoma Medication)

Serious: 0/14 (0%)

Deaths: 0/14

Other adverse events (1 terms — click to expand)

Reaction	System	Cosopt	Washout (no Glaucoma Medic…
Eye pressure greater than 30 mmHg	Eye disorders	—	—

Data from ClinicalTrials.gov NCT00906087 adverse events section.

Sponsor's own description

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.).

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.