Trial Outcomes & Findings for Patient Preference Comparison of AZARGA Versus COSOPT (NCT NCT01340014)

Results Overview

The participant completed a questionnaire on the Day 15 visit (ie, after administration of both study medications) consisting of a single preference question: "Thinking about the comfort of the two medications (1st and 2nd) that you took during this study, which medication do you prefer?" Preferred treatment is presented as a percentage.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

112 participants

Primary outcome timeframe

At the end of both periods, Day 15

Results posted on

2014-02-10

Participant Flow

Participants were recruited from 11 study centers located in Europe.

This reporting group includes all enrolled participants as treated.

Participant milestones

Participant milestones
Measure	AZARGA/COSOPT 1 drop AZARGA instilled in each eye twice a day for 7 days during Period 1, followed by 1 drop COSOPT instilled in each eye twice a day for 7 days during Period 2. A 48-hour washout period separated the two treatment periods.	COSOPT/AZARGA 1 drop COSOPT instilled in each eye twice a day for 7 days during Period 1, followed by 1 drop AZARGA instilled in each eye twice a day for 7 days during Period 2. A 48-hour washout period separated the two treatment periods.
Period 1, First 7 Days STARTED	55	57
Period 1, First 7 Days COMPLETED	53	57
Period 1, First 7 Days NOT COMPLETED	2	0
Period 2, Second 7 Days STARTED	53	57
Period 2, Second 7 Days COMPLETED	53	56
Period 2, Second 7 Days NOT COMPLETED	0	1

Reasons for withdrawal

Reasons for withdrawal
Measure	AZARGA/COSOPT 1 drop AZARGA instilled in each eye twice a day for 7 days during Period 1, followed by 1 drop COSOPT instilled in each eye twice a day for 7 days during Period 2. A 48-hour washout period separated the two treatment periods.	COSOPT/AZARGA 1 drop COSOPT instilled in each eye twice a day for 7 days during Period 1, followed by 1 drop AZARGA instilled in each eye twice a day for 7 days during Period 2. A 48-hour washout period separated the two treatment periods.
Period 1, First 7 Days Adverse Event	1	0
Period 1, First 7 Days Personal Reasons	1	0
Period 2, Second 7 Days Adverse Event	0	1

Baseline Characteristics

Patient Preference Comparison of AZARGA Versus COSOPT

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	AZARGA/COSOPT n=54 Participants 1 drop AZARGA instilled in each eye twice a day for 7 days during Period 1, followed by 1 drop COSOPT instilled in each eye twice a day for 7 days during Period 2. A 48-hour washout period separated the two treatment periods.	COSOPT/AZARGA n=54 Participants 1 drop COSOPT instilled in each eye twice a day for 7 days during Period 1, followed by 1 drop AZARGA instilled in each eye twice a day for 7 days during Period 2. A 48-hour washout period separated the two treatment periods.	Total n=108 Participants Total of all reporting groups
Age, Continuous	67.7 years STANDARD_DEVIATION 10.1 • n=99 Participants	65.0 years STANDARD_DEVIATION 11.92 • n=107 Participants	66.3 years STANDARD_DEVIATION 11.40 • n=206 Participants
Sex: Female, Male Female	38 Participants n=99 Participants	31 Participants n=107 Participants	69 Participants n=206 Participants
Sex: Female, Male Male	16 Participants n=99 Participants	23 Participants n=107 Participants	39 Participants n=206 Participants

PRIMARY outcome

Timeframe: At the end of both periods, Day 15

Population: This reporting group includes all participants who completed both treatment periods and completed the preference questionnaire, as treated.

The participant completed a questionnaire on the Day 15 visit (ie, after administration of both study medications) consisting of a single preference question: "Thinking about the comfort of the two medications (1st and 2nd) that you took during this study, which medication do you prefer?" Preferred treatment is presented as a percentage.

Outcome measures

Outcome measures
Measure	AZARGA n=108 Participants 1 drop AZARGA instilled in each eye twice a day for 7 days during Period 1 or Period 2	COSOPT n=108 Participants 1 drop COSOPT instilled in each eye twice a day for 7 days during Period 1 or Period 2
Preferred Treatment	60.2 Percentage of participants	39.8 Percentage of participants

SECONDARY outcome

Timeframe: Day 7 of each period

Population: This reporting group includes all participants who completed both treatment periods and completed the preference questionnaire, as treated, minus any missing responses.

Ocular discomfort was assessed by the participant 1 minute after instillation of the study medication. Ocular discomfort was rated on a 10-point scale (0=no discomfort, 9=substantial discomfort).

Outcome measures

Outcome measures
Measure	AZARGA n=108 Participants 1 drop AZARGA instilled in each eye twice a day for 7 days during Period 1 or Period 2	COSOPT n=108 Participants 1 drop COSOPT instilled in each eye twice a day for 7 days during Period 1 or Period 2
Ocular Discomfort	2.6 Units on a scale Standard Deviation 2.27	3.7 Units on a scale Standard Deviation 2.63

Adverse Events

AZARGA

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

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

Doug Hubatsch, Global Brand Leader, Medical Affairs

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