Trial Outcomes & Findings for AZARGA Transition Study in Taiwan for Patients With Uncontrolled Intraocular Pressure (NCT NCT01484951)

Results Overview

As measured at baseline and final visit with Goldmann applanation tonometry. The outcome measure was pre-specified for Timolol 0.5% only participants.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

74 participants

Primary outcome timeframe

Baseline, Week 8

Results posted on

2013-05-01

Participant Flow

Subjects were recruited from 3 study centers in Taiwan.

Participant milestones

Participant milestones
Measure	AZARGA Brinzolamide 1% and timolol 0.5% fixed combination eye drops, one drop administered to the study eye(s) twice daily (8:00 am and 8:00 pm) for up to 8 weeks.
Overall Study STARTED	74
Overall Study COMPLETED	69
Overall Study NOT COMPLETED	5

Reasons for withdrawal

Reasons for withdrawal
Measure	AZARGA Brinzolamide 1% and timolol 0.5% fixed combination eye drops, one drop administered to the study eye(s) twice daily (8:00 am and 8:00 pm) for up to 8 weeks.
Overall Study Adverse Event	3
Overall Study Personal Reasons	1
Overall Study Non-Compliance	1

Baseline Characteristics

AZARGA Transition Study in Taiwan for Patients With Uncontrolled Intraocular Pressure

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	AZARGA n=74 Participants Brinzolamide 1% and timolol 0.5% fixed combination eye drops, one drop administered to the study eye(s) twice daily (8:00 am and 8:00 pm) for up to 8 weeks.
Age Continuous	60 years STANDARD_DEVIATION 15 • n=5 Participants
Sex: Female, Male Female	42 Participants n=5 Participants
Sex: Female, Male Male	32 Participants n=5 Participants
Region of Enrollment Taiwan	74 participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline, Week 8

Population: Per protocol: All participants who received study medication, completed all study visits, and satisfied inclusion/exclusion criteria.

As measured at baseline and final visit with Goldmann applanation tonometry. The outcome measure was pre-specified for Timolol 0.5% only participants.

Outcome measures

Outcome measures
Measure	AZARGA n=9 Participants Brinzolamide 1% and timolol 0.5% fixed combination eye drops, one drop administered to the study eye(s) twice daily (8:00 am and 8:00 pm) for up to 8 weeks.
Change in Intraocular Pressure (IOP) at the Final Visit From Prior Beta-blocker Monotherapy (Timolol 0.5% Only) Change at Week 8	-3.56 millimeters mercury (mmHg) Standard Deviation 3.16
Change in Intraocular Pressure (IOP) at the Final Visit From Prior Beta-blocker Monotherapy (Timolol 0.5% Only) Baseline	18.22 millimeters mercury (mmHg) Standard Deviation 2.64

SECONDARY outcome

Timeframe: Week 8

Population: Per protocol: All participants who received study medication, completed all study visits, and satisfied inclusion/exclusion criteria.

As measured with Goldmann applanation tonometry. The outcome measure was pre-specified for all participants.

Outcome measures

Outcome measures
Measure	AZARGA n=70 Participants Brinzolamide 1% and timolol 0.5% fixed combination eye drops, one drop administered to the study eye(s) twice daily (8:00 am and 8:00 pm) for up to 8 weeks.
Percentage of Patients With Target IOP (≤18 mmHg), Regardless of Prior Therapy	54.3 Percentage of Participants

Adverse Events

AZARGA

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	AZARGA n=74 participants at risk Brinzolamide 1% and timolol 0.5% fixed combination eye drops, one drop administered to the study eye(s) twice daily (8:00 am and 8:00 pm) for up to 8 weeks.
Eye disorders Vision blurred	6.8% 5/74 • Adverse events were collected for the duration of the study (e.g., 10 months, 8 days). Individual adverse events were captured from the time of first administration of test article to the end-of-study visit (8 weeks).

Additional Information

Abayomi Ogundele, Pharm.D

Alcon Global Medical Affairs

Phone: 1-888-451-3937

Results disclosure agreements

Principal investigator is a sponsor employee Alcon reserves the right to review the results communication prior to its public release.
Publication restrictions are in place

Restriction type: OTHER