Patient Preference Comparison of AZARGA Versus COSOPT

• Sponsor: Alcon Research (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01340014
• Collaborator: (none)
• Enrollment: 112
• Arms: 2
• Duration (Months): 13

Study Details

Study Description

Brief Summary

The purpose of this study was to assess patient preference regarding ocular comfort of AZARGA® compared to COSOPT® after one week instillation of each study medication.

Condition or Disease	Intervention/Treatment	Phase
Open-Angle Glaucoma; Ocular Hypertension	Drug: Brinzolamide 1.0% + Timolol 0.5% ophthalmic suspension; Drug: Dorzolamide 2.0% + Timolol 0.5% ophthalmic solution	Phase 4

Detailed Description

At the Screening Visit, each intervention was instilled in one eye in a contralateral fashion to establish baseline ocular comfort prior to randomization. A 48-hour washout period separated the two treatment periods.

Study Design

• Study Type: Interventional
• Actual Enrollment: 112 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Single (Participant)
• Primary Purpose: Treatment
• Official Title: Patient Preference Comparison of AZARGA Versus COSOPT in Patients With Open-Angle Glaucoma or Ocular Hypertension
• Study Start Date: Sep 1, 2011
• Actual Primary Completion Date: Oct 1, 2012
• Actual Study Completion Date: Oct 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Other: AZARGA/COSOPT 1 drop AZARGA instilled in each eye twice a day for 7 days, followed by 1 drop COSOPT instilled in each eye twice a day for 7 days. A 48-hour washout period separated the two treatment periods.	Drug: Brinzolamide 1.0% + Timolol 0.5% ophthalmic suspension; Other Names: AZARGA® ; Drug: Dorzolamide 2.0% + Timolol 0.5% ophthalmic solution; Other Names: COSOPT®
Other: COSOPT/AZARGA 1 drop COSOPT instilled in each eye twice a day for 7 days, followed by 1 drop AZARGA instilled in each eye twice a day for 7 days. A 48-hour washout period separated the two treatment periods.	Drug: Brinzolamide 1.0% + Timolol 0.5% ophthalmic suspension; Other Names: AZARGA® ; Drug: Dorzolamide 2.0% + Timolol 0.5% ophthalmic solution; Other Names: COSOPT®

Outcome Measures

Primary Outcome Measures

1. Preferred Treatment [At the end of both periods, Day 15]

   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.

Secondary Outcome Measures

1. Ocular Discomfort [Day 7 of each period]

   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).

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Clinical diagnosis of ocular hypertension, open-angle with or without pseudoexfoliation or pigment dispersion glaucoma in both eyes.

• On a stable regimen of intraocular pressure-lowering (IOP) medication within 30 days of Screening Visit.

• IOP considered safe (in the opinion of the Investigator) in both eyes in such a way that assures clinical stability of vision and the optic nerve throughout the study period.

• IOP between 19 and 35 millimeters mercury (mmHg) in at least one eye (study eye).

• Willing to discontinue the use of all other ocular drugs (prescribed and over-the-counter) prior to receiving the screening dose during the Screening Visit and for the entire course of the study.

• Able to follow instructions and willing and able to attend all study visits.

• Read, sign, and date an Ethics Committee reviewed and approved Informed Consent Form.

• Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

• Known medical history of allergy, hypersensitivity or poor tolerance to any component of the preparations to be used in this study that is deemed clinically significant in the opinion of the Principal Investigator.

• Best corrected visual acuity worse than 20/80 Snellen in either eye.

• Any abnormality preventing reliable applanation tonometry in either eye.

• Intraocular conventional surgery or laser surgery in either eye less than 3 months prior to the Screening Visit.

• Risk of visual field or visual acuity worsening as a consequence of participation in the study, in the Investigator's best judgment.

• Progressive retinal or optic nerve disease from any cause.

• History of ocular herpes simplex.

• Severe allergic rhinitis or bronchial hypersensitivity that would preclude the safe administration of a topical beta-blocker.

• Bronchial asthma, a history of bronchial asthma, or severe chronic obstructive pulmonary disease that would preclude the safe administration of a topical beta-blocker.

• Women who are pregnant, lactating, or of childbearing potential and not using a reliable means of birth control.

• Participation in any other investigational study within 30 days prior to the Screening/baseline Visit.

• Other protocol-defined exclusion criteria may apply.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Alcon Research

Investigators

• Study Director: Severine Durier, Pharm.D, Alcon Global Medical Affairs, Europe

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Alcon Research
• ClinicalTrials.gov Identifier: NCT01340014
• Other Study ID Numbers: RDG-10-251; 2010-024244-15
• First Posted: Apr 21, 2011
• Last Update Posted: Feb 10, 2014
• Last Verified: Jan 1, 2014

• Keywords provided by Alcon Research: Glaucoma; Intraocular pressure; Tonometry, ocular
• Additional relevant MeSH terms: Glaucoma; Glaucoma, Open-Angle; Ocular Hypertension; Hypertension; Timolol; Dorzolamide; Ophthalmic Solutions; Brinzolamide

Study Results

Participant Flow

Recruitment Details	Participants were recruited from 11 study centers located in Europe.
Pre-assignment Detail	This reporting group includes all enrolled participants as treated.

Arm/Group Title	AZARGA/COSOPT	COSOPT/AZARGA
Arm/Group Description	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.	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 Title: Period 1, First 7 Days
STARTED	55	57
COMPLETED	53	57
NOT COMPLETED	2	0
Period Title: Period 1, First 7 Days
STARTED	53	57
COMPLETED	53	56
NOT COMPLETED	0	1

Baseline Characteristics

Arm/Group Title	AZARGA/COSOPT	COSOPT/AZARGA	Total
Arm/Group Description	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.	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 of all reporting groups
Overall Participants	54	54	108
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	67.7 (10.1)	65.0 (11.92)	66.3 (11.40)
Sex: Female, Male (Count of Participants)
Female	38 70.4%	31 57.4%	69 63.9%
Male	16 29.6%	23 42.6%	39 36.1%

Outcome Measures

1. Primary Outcome

Title	Preferred Treatment
Description	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.
Time Frame	At the end of both periods, Day 15

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	AZARGA	COSOPT
Arm/Group Description	1 drop AZARGA instilled in each eye twice a day for 7 days during Period 1 or Period 2	1 drop COSOPT instilled in each eye twice a day for 7 days during Period 1 or Period 2
Measure Participants	108	108
Number [Percentage of participants]	60.2 111.5%	39.8 73.7%

2. Secondary Outcome

Title	Ocular Discomfort
Description	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).
Time Frame	Day 7 of each period

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	AZARGA	COSOPT
Arm/Group Description	1 drop AZARGA instilled in each eye twice a day for 7 days during Period 1 or Period 2	1 drop COSOPT instilled in each eye twice a day for 7 days during Period 1 or Period 2
Measure Participants	108	108
Mean (Standard Deviation) [Units on a scale]	2.6 (2.27)	3.7 (2.63)

Adverse Events

Time Frame	Adverse events were collected for the duration of the study (September 2011 to October 2012). An adverse event was defined as any untoward medical condition in a subject administered a study treatment regardless of causal relationship.
Adverse Event Reporting Description	This reporting group includes all participants who received at least one dose of study medication. At each visit the Investigator inquired about adverse events by asking the standard question, "Have you had any health problems since your last study visit?"
Arm/Group Title	AZARGA		COSOPT
Arm/Group Description	1 drop AZARGA instilled in each eye twice a day for 7 days during Period 1 or Period 2		1 drop COSOPT instilled in each eye twice a day for 7 days during Period 1 or Period 2
All Cause Mortality
	AZARGA		COSOPT
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	AZARGA		COSOPT
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/112 (0%)		0/112 (0%)
Other (Not Including Serious) Adverse Events
	AZARGA		COSOPT
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/112 (0%)		0/112 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

Sponsor reserves the right of prior review of any publication or presentation of information related to the study.