A Comfort Study of Brinzolamide 1% / Brimonidine 0.2% Fixed Combination, Brinzolamide 1% and Brimonidine 0.2%

• Sponsor: Alcon Research (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01426867
• Collaborator: (none)
• Enrollment: 103
• Arms: 3
• Duration (Months): 2

Study Details

Study Description

Brief Summary

The purpose of this study was to describe the ocular discomfort immediately upon instillation of Brinzolamide 1%/Brimonidine 0.2% Tartrate Ophthalmic Suspension, Brinzolamide 1% Ophthalmic Suspension, and Brimonidine Tartrate 0.2% Ophthalmic Solution in subjects with open-angle glaucoma and/or ocular hypertension.

Condition or Disease	Intervention/Treatment	Phase
Open-Angle Glaucoma; Ocular Hypertension	Drug: Brinzolamide 1%/brimonidine tartrate 0.2% ophthalmic suspension; Drug: Brinzolamide ophthalmic suspension, 1%; Drug: Brimonidine tartrate ophthalmic solution, 0.2%	Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 103 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: A Descriptive Comfort Study of Brinzolamide 1% / Brimonidine Tartrate 0.2% Fixed Combination Ophthalmic Suspension, Brinzolamide 1% Ophthalmic Suspension and Brimonidine Tartrate 0.2% Ophthalmic Solution in Patients With Open-Angle Glaucoma or Ocular Hypertension
• Study Start Date: Sep 1, 2011
• Actual Primary Completion Date: Nov 1, 2011
• Actual Study Completion Date: Nov 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Brinz/Brim Brinzolamide 1%/brimonidine tartrate 0.2% ophthalmic suspension, 1 drop instilled in each affected eye 3 times a day for 7 days	Drug: Brinzolamide 1%/brimonidine tartrate 0.2% ophthalmic suspension
Active Comparator: Brinzolamide Brinzolamide ophthalmic suspension, 1%, 1 drop instilled in each affected eye 3 times a day for 7 days	Drug: Brinzolamide ophthalmic suspension, 1%
Active Comparator: Brimonidine Brimonidine tartrate ophthalmic solution, 0.2%, 1 drop instilled in each affected eye 3 times a day for 7 days	Drug: Brimonidine tartrate ophthalmic solution, 0.2%

Outcome Measures

Primary Outcome Measures

1. Mean Ocular Discomfort Score [Week 1]

   Ocular discomfort was assessed by the subject immediately following the 8 AM instillation of study drug and rated on a 5-point scale: 0 (none), 1 (mild), 2 (moderate), 3 (severe), and 4 (very severe).

Eligibility Criteria

Criteria

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

Inclusion Criteria:

• Sign Informed Consent document.

• Diagnosis of open-angle glaucoma or ocular hypertension

• Other protocol-specified inclusion criteria may apply.

Exclusion Criteria:

• Females of childbearing potential if pregnant, lactating, or not using highly effective birth control measures.

• Severe central vision loss in either eye.

• Any chronic or recurrent inflammatory eye disease.

• Ocular trauma within the preceding 6 months.

• Ocular infection or ocular inflammation within the preceding 3 months.

• Best-corrected visual acuity score worse than 55 letters using the Early Treatment Diabetic Retinopathy Study chart.

• Any intraocular surgery within the preceding 6 months.

• Any ocular laser surgery within the preceding 3 months.

• History or current evidence of severe illness or any other conditions which would make the subject, in the opinion of the Investigator, unsuitable for the study.

• Other protocol-defined exclusion criteria may apply.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Alcon Research

Investigators

• Study Director: Ravaughn Williams, OD, MS, Alcon Research

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Alcon Research
• ClinicalTrials.gov Identifier: NCT01426867
• Other Study ID Numbers: C-11-002
• First Posted: Sep 1, 2011
• Last Update Posted: Jul 8, 2013
• Last Verified: May 1, 2013

• Keywords provided by Alcon Research: Open-Angle Glaucoma; Ocular Hypertension; Intraocular Pressure; Brinzolamide; Brimonidine
• Additional relevant MeSH terms: Glaucoma; Glaucoma, Open-Angle; Ocular Hypertension; Hypertension; Brimonidine Tartrate; Ophthalmic Solutions; Brinzolamide

Study Results

Participant Flow

Recruitment Details	Subjects were recruited from 5 investigational centers in the United States.
Pre-assignment Detail	Of the 103 enrolled, 2 subjects did not meet inclusion/exclusion criteria and were exited from the study as screen failures prior to randomization. This reporting group includes all randomized subjects (101).

Arm/Group Title	Brinz/Brim	Brinzolamide	Brimonidine
Arm/Group Description	Brinzolamide 1%/brimonidine tartrate 0.2% ophthalmic suspension, 1 drop instilled in each affected eye 3 times a day for 7 days	Brinzolamide ophthalmic suspension, 1%, 1 drop instilled in each affected eye 3 times a day for 7 days	Brimonidine tartrate ophthalmic solution, 0.2%, 1 drop instilled in each affected eye 3 times a day for 7 days
Period Title: Overall Study
STARTED	33	34	34
COMPLETED	33	34	34
NOT COMPLETED	0	0	0

Baseline Characteristics

Arm/Group Title	Brinz/Brim	Brinzolamide	Brimonidine	Total
Arm/Group Description	Brinzolamide 1%/brimonidine tartrate 0.2% ophthalmic suspension, 1 drop instilled in each affected eye 3 times a day for 7 days	Brinzolamide ophthalmic suspension, 1%, 1 drop instilled in each affected eye 3 times a day for 7 days	Brimonidine tartrate ophthalmic solution, 0.2%, 1 drop instilled in each affected eye 3 times a day for 7 days	Total of all reporting groups
Overall Participants	33	34	34	101
Age, Customized (participants) [Number]
18 to 64 years	8 24.2%	12 35.3%	11 32.4%	31 30.7%
≥65 years	25 75.8%	22 64.7%	23 67.6%	70 69.3%
Sex: Female, Male (Count of Participants)
Female	20 60.6%	23 67.6%	23 67.6%	66 65.3%
Male	13 39.4%	11 32.4%	11 32.4%	35 34.7%
Region of Enrollment (participants) [Number]
United States	33 100%	34 100%	34 100%	101 100%

Outcome Measures

1. Primary Outcome

Title	Mean Ocular Discomfort Score
Description	Ocular discomfort was assessed by the subject immediately following the 8 AM instillation of study drug and rated on a 5-point scale: 0 (none), 1 (mild), 2 (moderate), 3 (severe), and 4 (very severe).
Time Frame	Week 1

Outcome Measure Data

Analysis Population Description

Intent-to-Treat (ITT): All subjects who received study medication and had at least 1 scheduled on-therapy visit.

Arm/Group Title	Brinz/Brim	Brinzolamide	Brimonidine
Arm/Group Description	Brinzolamide 1%/brimonidine tartrate 0.2% ophthalmic suspension, 1 drop instilled in each affected eye 3 times a day for 7 days	Brinzolamide ophthalmic suspension, 1%, 1 drop instilled in each affected eye 3 times a day for 7 days	Brimonidine tartrate ophthalmic solution, 0.2%, 1 drop instilled in each affected eye 3 times a day for 7 days
Measure Participants	33	34	34
Mean (Standard Deviation) [Units on a scale]	0.8 (0.9)	0.4 (0.6)	0.3 (0.5)

Adverse Events

Time Frame	Adverse events were collected for the duration of the study. The safety population includes all subjects who were exposed to study medication.
Adverse Event Reporting Description	An adverse event was defined as any untoward medical occurrence in a subject administered a study medication, regardless of whether or not the event had a causal relationship with the medication. Adverse events were obtained as solicited comments from the subjects and as observations by the Investigator as outlined in the study protocol.
Arm/Group Title	Brinz/Brim		Brinzolamide		Brimonidine
Arm/Group Description	Brinzolamide 1%/brimonidine tartrate 0.2% ophthalmic suspension, 1 drop instilled in each affected eye 3 times a day for 7 days		Brinzolamide ophthalmic suspension, 1%, 1 drop instilled in each affected eye 3 times a day for 7 days		Brimonidine tartrate ophthalmic solution, 0.2%, 1 drop instilled in each affected eye 3 times a day for 7 days
All Cause Mortality
	Brinz/Brim		Brinzolamide		Brimonidine
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)		/ (NaN)
Serious Adverse Events
	Brinz/Brim		Brinzolamide		Brimonidine
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/33 (0%)		0/34 (0%)		0/34 (0%)
Other (Not Including Serious) Adverse Events
	Brinz/Brim		Brinzolamide		Brimonidine
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	5/33 (15.2%)		7/34 (20.6%)		0/34 (0%)
Eye disorders
Vision blurred	2/33 (6.1%)		4/34 (11.8%)		0/34 (0%)
Eye irritation	2/33 (6.1%)		3/34 (8.8%)		0/34 (0%)
Nervous system disorders
Dysgeusia	2/33 (6.1%)		1/34 (2.9%)		0/34 (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.