Trial Outcomes & Findings for Efficacy and Tolerability of AZARGA® as Replacement Therapy in Patients on COMBIGAN® Therapy in Canada (NCT NCT01415401)

Results Overview

IOP (fluid pressure inside the eye) was assessed by Goldmann applanation tonometry and measured in millimeters of mercury (mmHg). A higher IOP can be a greater risk for developing glaucoma or glaucoma progression (leading to optic nerve damage). A more negative change indicates a greater amount of improvement. One eye was chosen as the study eye, and only data from the study eye were used for the efficacy analysis.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

57 participants

Primary outcome timeframe

Baseline, Week 8

Results posted on

2014-07-01

Participant Flow

Participants were recruited from 8 study centers located in Canada.

Of the 57 enrolled, 3 participants were exited as screen failures. This reporting group includes all participants who received study medication (54).

Participant milestones

Participant milestones
Measure	AZARGA Brinzolamide 1% / timolol 0.5% maleate fixed combination, 1 drop self-administered in study eye(s) twice daily for 8 weeks (8AM and 8PM)
Overall Study STARTED	54
Overall Study COMPLETED	47
Overall Study NOT COMPLETED	7

Reasons for withdrawal

Reasons for withdrawal
Measure	AZARGA Brinzolamide 1% / timolol 0.5% maleate fixed combination, 1 drop self-administered in study eye(s) twice daily for 8 weeks (8AM and 8PM)
Overall Study Adverse Event	5
Overall Study DId not meet inclusion/exclusion criteri	1
Overall Study Terminated by Sponsor	1

Baseline Characteristics

Efficacy and Tolerability of AZARGA® as Replacement Therapy in Patients on COMBIGAN® Therapy in Canada

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	AZARGA n=54 Participants Brinzolamide 1% / timolol 0.5% maleate fixed combination, 1 drop self-administered in study eye(s) twice daily for 8 weeks (8AM and 8PM)
Age, Continuous	69.6 years STANDARD_DEVIATION 10.37 • n=5 Participants
Sex: Female, Male Female	28 Participants n=5 Participants
Sex: Female, Male Male	26 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline, Week 8

Population: This analysis population includes all subjects who received study medication and had at least one on-therapy study visit. Last observation carried forward (LOCF) was used.

IOP (fluid pressure inside the eye) was assessed by Goldmann applanation tonometry and measured in millimeters of mercury (mmHg). A higher IOP can be a greater risk for developing glaucoma or glaucoma progression (leading to optic nerve damage). A more negative change indicates a greater amount of improvement. One eye was chosen as the study eye, and only data from the study eye were used for the efficacy analysis.

Outcome measures

Outcome measures
Measure	AZARGA n=54 Participants Brinzolamide 1% / timolol 0.5% maleate fixed combination, 1 drop self-administered in study eye(s) twice daily for 8 weeks (8AM and 8PM)
Change in IOP at the Final Visit From Prior Brimonidine 0.2%/Timolol 0.5% Fixed Combination (COMBIGAN®) Therapy (i.e. From Baseline) Baseline	22.24 mmHg Standard Deviation 3.150
Change in IOP at the Final Visit From Prior Brimonidine 0.2%/Timolol 0.5% Fixed Combination (COMBIGAN®) Therapy (i.e. From Baseline) Change from baseline at Week 8	-2.24 mmHg Standard Deviation 3.928

SECONDARY outcome

Timeframe: Week 8

Population: This analysis population includes all subjects who received study medication, completed all study visits, and satisfied inclusion/exclusion criteria. In addition, no imputation methods were employed; therefore only efficacy measurements available at each visit and time point were analyzed.

IOP (fluid pressure inside the eye) was assessed by Goldmann applanation tonometry and measured in mmHg. A higher IOP can be a greater risk for developing glaucoma or glaucoma progression (leading to optic nerve damage). One eye was chosen as the study eye, and only data from the study eye were used for the efficacy analysis.

Outcome measures

Outcome measures
Measure	AZARGA n=47 Participants Brinzolamide 1% / timolol 0.5% maleate fixed combination, 1 drop self-administered in study eye(s) twice daily for 8 weeks (8AM and 8PM)
Percentage of Subjects Who Reach Target IOP (≤ 18 mmHg)	36.2 percentage of participants

Adverse Events

AZARGA

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	AZARGA n=54 participants at risk Brinzolamide 1% / timolol 0.5% maleate fixed combination, 1 drop self-administered in study eye(s) twice daily for 8 weeks (8AM and 8PM)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Basal cell carcinoma	1.9% 1/54 • Adverse events (AEs) were collected for the duration of the study (1 year, 9 months). This analysis group includes all subjects who received study medication. An AE is defined as any untoward medical occurrence in a subject who is administered a study treatment regardless of whether or not the event has a causal relationship with the treatment. Adverse events were obtained as solicited comments from the study patients and as observations by the Investigator as outlined in the study protocol.

Other adverse events

Adverse event data not reported

Additional Information

Doug Hubatsch, Global Brand Leader

Alcon Research, Ltd.

Phone: 1-888-451-3937

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Sponsor reserves the right of prior review of any publication or presentation of information related to the study.
Publication restrictions are in place

Restriction type: OTHER