Trial Outcomes & Findings for Effect of Myocilin Genetic Variants on Intraocular Pressure and Pressure Variation in Sitting and Supine Positions (NCT NCT00906087)

NCT ID: NCT00906087

Last Updated: 2017-06-02

Results Overview

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

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

14 participants

Primary outcome timeframe

10 weeks

Results posted on

2017-06-02

Participant Flow

Participant milestones

Participant milestones
Measure	Cosopt Cosopt 1 drop two times daily was administered for 6 weeks. Cosopt (combination eyedrop of dorzolamide and timolol): One drop in each eye every twelve hours for six weeks
Initial Washout STARTED	14
Initial Washout Completed Screening	14
Initial Washout Begin Washout	13
Initial Washout Completed Washout and Continue Protocol	12
Initial Washout COMPLETED	12
Initial Washout NOT COMPLETED	2
Cosopt Treatment 6 Weeks STARTED	12
Cosopt Treatment 6 Weeks COMPLETED	12
Cosopt Treatment 6 Weeks NOT COMPLETED	0
Final Washout Period 4 Weeks STARTED	12
Final Washout Period 4 Weeks COMPLETED	12
Final Washout Period 4 Weeks NOT COMPLETED	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Cosopt Cosopt 1 drop two times daily was administered for 6 weeks. Cosopt (combination eyedrop of dorzolamide and timolol): One drop in each eye every twelve hours for six weeks
Initial Washout Withdrawal by Subject	1
Initial Washout Physician Decision	1

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Cosopt n=14 Participants Cosopt 1 drop two times daily was administered for 6 weeks. Cosopt (combination eyedrop of dorzolamide and timolol): One drop in each eye every twelve hours for six weeks
Age, Continuous	60 years STANDARD_DEVIATION 19.5 • n=99 Participants
Sex: Female, Male Female	4 Participants n=99 Participants
Sex: Female, Male Male	10 Participants n=99 Participants
Region of Enrollment United States	14 participants n=99 Participants
Intraocular pressure right eye Baseline at initial visit	15.6 mmHg STANDARD_DEVIATION 2.10 • n=99 Participants
Intraocular pressure right eye After 4 week washout	19.9 mmHg STANDARD_DEVIATION 4.33 • n=99 Participants
Intraocular pressure left eye Baseline at initial visit	16.4 mmHg STANDARD_DEVIATION 3.61 • n=99 Participants
Intraocular pressure left eye After 4 week washout	20.4 mmHg STANDARD_DEVIATION 5.57 • n=99 Participants

PRIMARY outcome

Timeframe: 10 weeks

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

Outcome measures

Outcome measures
Measure	Cosopt n=12 Participants Intraocular pressure comparison after washout of Cosopt and while on treatment with Cosopt Cosopt (combination eyedrop of dorzolamide and timolol): One drop in each eye every twelve hours for six weeks
Intraocular Pressure in Sitting and Supine Positions. Supine left eye	22.8 mmHg Standard Deviation 4.32
Intraocular Pressure in Sitting and Supine Positions. Sitting right eye	18.5 mmHg Standard Deviation 2.94
Intraocular Pressure in Sitting and Supine Positions. Sitting left eye	19.4 mmHg Standard Deviation 3.23
Intraocular Pressure in Sitting and Supine Positions. Supine right eye	22.2 mmHg Standard Deviation 3.06

PRIMARY outcome

Timeframe: 10 weeks

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

Outcome measures

Outcome measures
Measure	Cosopt n=12 Participants Intraocular pressure comparison after washout of Cosopt and while on treatment with Cosopt Cosopt (combination eyedrop of dorzolamide and timolol): One drop in each eye every twelve hours for six weeks
Blood Pressure in Sitting to Supine Positions Sitting systolic blood pressure	139.6 mmHg Standard Deviation 20.40
Blood Pressure in Sitting to Supine Positions Supine systolic blood pressure	133.8 mmHg Standard Deviation 21.7
Blood Pressure in Sitting to Supine Positions Sitting diastolic blood pressure	86.8 mmHg Standard Deviation 12.29
Blood Pressure in Sitting to Supine Positions Supine diastolic blood pressure	89.3 mmHg Standard Deviation 16.96

SECONDARY outcome

Timeframe: 10 week study

Population: Only 1 participant had a MYOC mutation in the 3 exons

Number of subjects with Myocilin Arg272Gly

Outcome measures

Outcome measures
Measure	Cosopt n=12 Participants Intraocular pressure comparison after washout of Cosopt and while on treatment with Cosopt Cosopt (combination eyedrop of dorzolamide and timolol): One drop in each eye every twelve hours for six weeks
Myocilin Mutation Arg272Gly in Subjects	1 Participants

Adverse Events

Cosopt

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Washout (no Glaucoma Medication)

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Cosopt n=12 participants at risk Cosopt 1 drop two times daily was administered for 6 weeks. Cosopt (combination eyedrop of dorzolamide and timolol): One drop in each eye every twelve hours for six weeks	Washout (no Glaucoma Medication) n=14 participants at risk After appropriate washout, no glaucoma medication was administered for 6 weeks.
Eye disorders Eye pressure greater than 30 mmHg	0.00% 0/12 • 12 weeks of study participation (2 week washout; 6 weeks on Cosopt; 4 weeks washout)	7.1% 1/14 • 12 weeks of study participation (2 week washout; 6 weeks on Cosopt; 4 weeks washout)

Additional Information

Sayoko E. Moroi

University of Michigan

Phone: 734-763-3732

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Sponsor wants an opportunity to review the data. I will send a PDF of this record on 3/17/2017.
Publication restrictions are in place

Restriction type: OTHER