Trial Outcomes & Findings for 12-Month Stability of Diurnal IOP Control on Cosopt (NCT NCT00379834)

Results Overview

Change from baseline in mean diurnal IOP (measured every two hours from 8AM to 8PM) averaged across on-treatment study visits (week 1, months 1, 6, 12)

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

10 participants

Primary outcome timeframe

12 months

Results posted on

2015-02-10

Participant Flow

10 subjects enrolled from WVU Eye Institute between April 2006 and April 2008

No patients excluded at any time

Participant milestones

Participant milestones
Measure	Cosopt Cosopt BID OU
Overall Study STARTED	10
Overall Study COMPLETED	8
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Reasons for withdrawal
Measure	Cosopt Cosopt BID OU
Overall Study Time constraints	2

Baseline Characteristics

12-Month Stability of Diurnal IOP Control on Cosopt

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Cosopt n=10 Participants Cosopt BID OU
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	4 Participants n=5 Participants
Age, Categorical >=65 years	6 Participants n=5 Participants
Age, Continuous	58 years STANDARD_DEVIATION 12 • n=5 Participants
Sex: Female, Male Female	7 Participants n=5 Participants
Sex: Female, Male Male	3 Participants n=5 Participants
Region of Enrollment United States	10 participants n=5 Participants

PRIMARY outcome

Timeframe: 12 months

Population: Selected by level funding available

Change from baseline in mean diurnal IOP (measured every two hours from 8AM to 8PM) averaged across on-treatment study visits (week 1, months 1, 6, 12)

Outcome measures

Outcome measures
Measure	Cosopt n=10 Participants Cosopt twice daily in both eyes
Diurnal Intraocular Pressure Control	-4.4 millimeters of mercury Standard Deviation 2.0

Adverse Events

Cosopt

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Tony Realini

West Virginia University

Phone: 3045986926

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place