24-hr Intraocular Pressure Control With SIMBRINZA ®

• Sponsor: Alcon Research (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02770248
• Collaborator: (none)
• Enrollment: 162
• Arms: 2
• Actual Duration (Months): 7.8

Study Details

Study Description

Brief Summary

The purpose of this study is to evaluate differences between treatments in mean change from baseline in 24-hr intraocular pressure (IOP) at Week 4.

Condition or Disease	Intervention/Treatment	Phase
Glaucoma	Drug: Brinzolamide 1%/brimonidine 0.2% tartrate ophthalmic suspension; Drug: Vehicle	Phase 4

Detailed Description

Subjects will undergo washout of pre-study IOP-lowering medications for the appropriate duration, then undergo 2 eligibility visits. Eligible subjects will be randomized 1:1, to receive masked SIMBRINZA ® or Vehicle for 4 weeks. Two 24-hour visits will be conducted (Day 0 and Week 4) during which intraocular pressure will be collected every 2 hours. The expected duration of subject participation in the study is 10 weeks.

Study Design

• Study Type: Interventional
• Actual Enrollment: 162 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: 24-hr Intraocular Pressure Control With Brinzolamide 1% / Brimonidine 0.2% Ophthalmic Suspension vs Vehicle
• Actual Study Start Date: May 23, 2016
• Actual Primary Completion Date: Jan 14, 2017
• Actual Study Completion Date: Jan 14, 2017

Arms and Interventions

Arm	Intervention/Treatment
Experimental: SIMBRINZA Brinzolamide 1% / Brimonidine 0.2% tartrate ophthalmic suspension, 1 drop 3 times per day in each eye at 8 AM, 3 PM, and 10 PM for 28 days	Drug: Brinzolamide 1%/brimonidine 0.2% tartrate ophthalmic suspension; Other Names: SIMBRINZA ®
Active Comparator: Vehicle Vehicle, 1 drop 3 times per day in each eye at 8 AM, 3 PM, and 10 PM for 28 days	Drug: Vehicle; Inactive ingredients used as a placebo for masking purposes

Outcome Measures

Primary Outcome Measures

1. Least Squares Mean Change From Baseline in 24-hr Intraocular Pressure (IOP) at Week 4 [Baseline (Day 0), Week 4]

   IOP (fluid pressure inside the eye) was measured in millimeters of mercury (mmHg). Change was calculated by taking the change from baseline at each time point and averaging the available changes. A higher IOP can be a greater risk for developing glaucoma or glaucoma progression (leading to optic nerve damage). A more negative change indicates greater improvement. Only one eye (study eye) contributed to the analysis.

Secondary Outcome Measures

1. Least Squares Mean Change From Baseline in Daytime IOP at Week 4 [Baseline (Day 0), Week 4]

   IOP (fluid pressure inside the eye) was measured in mmHg. Change was calculated by taking the change from baseline at each time point (8 AM through 8 PM) and averaging the available changes. A higher IOP can be a greater risk for developing glaucoma or glaucoma progression (leading to optic nerve damage). A more negative change indicates greater improvement. Only one eye (study eye) contributed to the analysis.

2. Least Squares Mean Change From Baseline in Nocturnal IOP at Week 4 [Baseline (Day 0), Week 4]

   IOP (fluid pressure inside the eye) was measured in mmHg. Change was calculated by taking the change from baseline at each time point (10 PM through 6 AM) and averaging the available changes. A higher IOP can be a greater risk for developing glaucoma or glaucoma progression (leading to optic nerve damage). A more negative change indicates greater improvement. Only one eye (study eye) contributed to the analysis.

3. Least Squares Mean Change From Baseline in IOP for Each Time Point (8 AM Through 6 AM) at Week 4 [Baseline (Day 0), Week 4]

   IOP (fluid pressure inside the eye) was measured in 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 greater improvement. Only one eye (study eye) contributed to the analysis.

Eligibility Criteria

Criteria

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

Inclusion Criteria:

• Diagnosis of either open-angle glaucoma or ocular hypertension;

• Able to attend all study related visits and be housed overnight at clinical site for the study assessments;

• Willing and able to sign an informed consent form;

• Other protocol-specified inclusion criteria may apply.

Exclusion Criteria:

• Women of childbearing potential who are pregnant, intend to become pregnant during the study, breast-feeding, or not using adequate birth control;

• Diagnosed with any form of glaucoma other than open angle glaucoma or ocular hypertension;

• Ocular surgeries or procedures excluded by the protocol;

• Diseases, illnesses, infections, or ocular abnormalities excluded by the protocol;

• Best-corrected visual acuity score less than 55 ETDRS letters (equivalent to approximately 20/80 Snellen) in either eye;

• Other protocol-specific exclusion criteria may apply.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Alcon Research

Investigators

• Study Director: Clinical Manager, GCRA, Alcon Research

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Alcon Research
• ClinicalTrials.gov Identifier: NCT02770248
• Other Study ID Numbers: GLT320a-P001
• First Posted: May 12, 2016
• Last Update Posted: Jul 2, 2018
• Last Verified: Jan 1, 2018

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Additional relevant MeSH terms: Glaucoma; Brimonidine Tartrate; Brinzolamide

Study Results

Participant Flow

Recruitment Details	Subjects were recruited from 16 study centers located in the United States.
Pre-assignment Detail	Of the 162 enrolled, 37 subjects were exited as screen failures prior to randomization. This reporting group includes all randomized subjects (125).

Arm/Group Title	SIMBRINZA	Vehicle
Arm/Group Description	Brinzolamide 1% / Brimonidine 0.2% tartrate ophthalmic suspension, 1 drop 3 times per day in each eye at 8 AM, 3 PM, and 10 PM for 28 days	Vehicle, 1 drop 3 times per day in each eye at 8 AM, 3 PM, and 10 PM for 28 days
Period Title: Overall Study
STARTED	62	63
COMPLETED	62	61
NOT COMPLETED	0	2

Baseline Characteristics

Arm/Group Title	SIMBRINZA	Vehicle	Total
Arm/Group Description	Brinzolamide 1% / Brimonidine 0.2% tartrate ophthalmic suspension, 1 drop 3 times per day in each eye at 8 AM, 3 PM, and 10 PM for 28 days	Vehicle, 1 drop 3 times per day in each eye at 8 AM, 3 PM, and 10 PM for 28 days	Total of all reporting groups
Overall Participants	62	61	123
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	67.5 (8.52)	63.6 (11.22)	65.5 (10.10)
Sex: Female, Male (Count of Participants)
Female	38 61.3%	41 67.2%	79 64.2%
Male	24 38.7%	20 32.8%	44 35.8%

Outcome Measures

1. Primary Outcome

Title	Least Squares Mean Change From Baseline in 24-hr Intraocular Pressure (IOP) at Week 4
Description	IOP (fluid pressure inside the eye) was measured in millimeters of mercury (mmHg). Change was calculated by taking the change from baseline at each time point and averaging the available changes. A higher IOP can be a greater risk for developing glaucoma or glaucoma progression (leading to optic nerve damage). A more negative change indicates greater improvement. Only one eye (study eye) contributed to the analysis.
Time Frame	Baseline (Day 0), Week 4

Outcome Measure Data

Analysis Population Description

Full Analysis Set

Arm/Group Title	SIMBRINZA	Vehicle
Arm/Group Description	Brinzolamide 1% / Brimonidine 0.2% tartrate ophthalmic suspension, 1 drop 3 times per day in each eye at 8 AM, 3 PM, and 10 PM for 28 days	Vehicle, 1 drop 3 times per day in each eye at 8 AM, 3 PM, and 10 PM for 28 days
Measure Participants	62	61
Least Squares Mean (95% Confidence Interval) [mmHg]	-3.09	-0.60

2. Secondary Outcome

Title	Least Squares Mean Change From Baseline in Daytime IOP at Week 4
Description	IOP (fluid pressure inside the eye) was measured in mmHg. Change was calculated by taking the change from baseline at each time point (8 AM through 8 PM) and averaging the available changes. A higher IOP can be a greater risk for developing glaucoma or glaucoma progression (leading to optic nerve damage). A more negative change indicates greater improvement. Only one eye (study eye) contributed to the analysis.
Time Frame	Baseline (Day 0), Week 4

Outcome Measure Data

Analysis Population Description

Full Analysis Set

Arm/Group Title	SIMBRINZA	Vehicle
Arm/Group Description	Brinzolamide 1% / Brimonidine 0.2% tartrate ophthalmic suspension, 1 drop 3 times per day in each eye at 8 AM, 3 PM, and 10 PM for 28 days	Vehicle, 1 drop 3 times per day in each eye at 8 AM, 3 PM, and 10 PM for 28 days
Measure Participants	62	61
Least Squares Mean (95% Confidence Interval) [mmHg]	-3.93	-0.51

3. Secondary Outcome

Title	Least Squares Mean Change From Baseline in Nocturnal IOP at Week 4
Description	IOP (fluid pressure inside the eye) was measured in mmHg. Change was calculated by taking the change from baseline at each time point (10 PM through 6 AM) and averaging the available changes. A higher IOP can be a greater risk for developing glaucoma or glaucoma progression (leading to optic nerve damage). A more negative change indicates greater improvement. Only one eye (study eye) contributed to the analysis.
Time Frame	Baseline (Day 0), Week 4

Outcome Measure Data

Analysis Population Description

Full Analysis Set

Arm/Group Title	SIMBRINZA	Vehicle
Arm/Group Description	Brinzolamide 1% / Brimonidine 0.2% tartrate ophthalmic suspension, 1 drop 3 times per day in each eye at 8 AM, 3 PM, and 10 PM for 28 days	Vehicle, 1 drop 3 times per day in each eye at 8 AM, 3 PM, and 10 PM for 28 days
Measure Participants	62	61
Least Squares Mean (95% Confidence Interval) [mmHg]	-1.88	-0.73

4. Secondary Outcome

Title	Least Squares Mean Change From Baseline in IOP for Each Time Point (8 AM Through 6 AM) at Week 4
Description	IOP (fluid pressure inside the eye) was measured in 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 greater improvement. Only one eye (study eye) contributed to the analysis.
Time Frame	Baseline (Day 0), Week 4

Outcome Measure Data

Analysis Population Description

Full Analysis Set

Arm/Group Title	SIMBRINZA	Vehicle
Arm/Group Description	Brinzolamide 1% / Brimonidine 0.2% tartrate ophthalmic suspension, 1 drop 3 times per day in each eye at 8 AM, 3 PM, and 10 PM for 28 days	Vehicle, 1 drop 3 times per day in each eye at 8 AM, 3 PM, and 10 PM for 28 days
Measure Participants	62	61
8AM	-3.28	-0.49
10AM	-5.05	-0.61
12PM	-4.03	-0.27
2PM	-3.36	-0.66
4PM	-3.95	-0.51
6PM	-4.46	-0.32
8PM	-3.42	-0.72
10PM	-2.10	-0.67
12AM	-1.79	-0.83
2AM	-2.30	-0.55
4AM	-1.42	-0.98
6AM	-1.95	-0.63

Adverse Events

Time Frame	Day 0 treatment through study completion, an average of 4 weeks
Adverse Event Reporting Description	An AE was 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. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. Two subjects were administered both Investigational Products. For the Safety analysis, they are grouped under the first administered treatment. "As treated" analysis is reported.
Arm/Group Title	SIMBRINZA		Vehicle
Arm/Group Description	All subjects exposed to SIMBRINZA		All subjects exposed to Vehicle
All Cause Mortality
	SIMBRINZA		Vehicle
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/64 (0%)		0/60 (0%)
Serious Adverse Events
	SIMBRINZA		Vehicle
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/64 (0%)		2/60 (3.3%)
Blood and lymphatic system disorders
Thrombocytopenia	0/64 (0%)		1/60 (1.7%)
Gastrointestinal disorders
Haemorrhoids	0/64 (0%)		1/60 (1.7%)
Infections and infestations
Sepsis	0/64 (0%)		1/60 (1.7%)
Other (Not Including Serious) Adverse Events
	SIMBRINZA		Vehicle
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/64 (0%)		4/60 (6.7%)
Eye disorders
Conjunctival hyperaemia	0/64 (0%)		4/60 (6.7%)

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.