A Comparison of Azopt Versus Placebo Added to Xalatan in Patients With Elevated Intraocular Pressure (IOP) on a Prostaglandin

• Sponsor: Alcon Research (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00759941
• Collaborator: (none)
• Enrollment: 86
• Location: 1
• Arms: 2
• Duration (Months): 21
• Patients Per Site Per Month: 4.1

Study Details

Study Description

Brief Summary

The purpose of this study was to assess the efficacy of adding Azopt dosed three times a day to Xalatan as compared to that of adding placebo to Xalatan in patients with elevated intraocular pressure.

Condition or Disease	Intervention/Treatment	Phase
Glaucoma	Drug: Brinzolamide 1% ophthalmic solution (Azopt); Drug: Placebo eye drops; Drug: Latanoprost 0.005% ophthalmic solution (Xalatan)	Phase 4

Study Design

• Study Type: Interventional
• Actual Enrollment: 86 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: A Comparison of Brinzolamide Ophthalmic Suspension, 1% (Azopt) TID vs. Placebo TID Added to Latanoprost Ophthalmic Solution, 0.005% (Xalatan) in Patients With Elevated IOP on a Prostaglandin
• Study Start Date: Oct 1, 2007
• Actual Primary Completion Date: Jul 1, 2009
• Actual Study Completion Date: Jul 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Xalatan + Azopt Xalatan dosed once a day at 10 pm, with Azopt dosed three times a day at 8 AM, 2 PM, and 10:05 PM as an adjunctive therapy for 3 months.	Drug: Brinzolamide 1% ophthalmic solution (Azopt); One drop three times a day in both eyes for 3 months; Other Names: AZOPT ; Drug: Latanoprost 0.005% ophthalmic solution (Xalatan); One drop once a day in both eyes for 3 months; Other Names: Xalatan
Active Comparator: Xalatan + Placebo Xalatan dosed once a day at 10 pm, with placebo dosed three times a day at 8 AM, 2 PM, and 10:05 PM concomitantly for 3 months.	Drug: Placebo eye drops; One drop three times a day in both eyes for 3 months; Drug: Latanoprost 0.005% ophthalmic solution (Xalatan); One drop once a day in both eyes for 3 months; Other Names: Xalatan

Outcome Measures

Primary Outcome Measures

1. Mean Change From Baseline in Intraocular Pressure, 8 AM, at 3 Months [Day 0, 3 months]

   Intraocular pressure was measured by Goldmann applanation tonometry. A negative number indicated a reduction in intraocular pressure.

2. Mean Change From Baseline in Intraocular Pressure, 12 PM, at 3 Months [Day 0, 3 months]

   Intraocular pressure was measured by Goldmann applanation tonometry. A negative number indicated a reduction in intraocular pressure.

3. Mean Change From Baseline in Intraocular Pressure, 4 PM, at 3 Months [Day 0, 3 months]

   Intraocular pressure was measured by Goldmann applanation tonometry. A negative number indicated a reduction in intraocular pressure.

4. Mean Change From Baseline in Intraocular Pressure, Diurnal, at 3 Months [Day 0, 3 months]

   Diurnal intraocular pressure is the mean of the three timepoints measured (8AM, 12PM & 4PM). Intraocular pressure was measured by Goldmann applanation tonometry. A negative number indicated a reduction in mean intraocular pressure.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 35 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Unilateral or bilateral primary open angle glaucoma, ocular hypertension or pseudoexfoliation syndrome.

• Intraocular pressure greater than 18 mmHg (mean diurnal) and less than 32 mmHg.

• Other protocol-defined inclusion criteria applied.

Exclusion:

• Previous intraocular surgery, except uncomplicated clear cornea phacoemulsification or argon laser trabeculoplasty.

• Argon laser trabeculoplasty or phacoemulsification within the last 3 months.

• Central corneal thickness outside the 500 - 600 (inclusive) micron range as measured by ultrasonic pachymetry.

• Ocular or periocular inflammation within 3 months prior to study (except blepharitis related or seasonal allergic conjunctivitis).

• History of uveitis or previous intraocular inflammation (other than post-operatively).

• Hypersensitivity to sulfa, or benzalkonium chloride.

• History of use of any steroids for over 1 week within 3 months of screening or likely need for any corticosteroids during the study (except inhaled, nasal or topical non-ocular).

• Other protocol-defined exclusion criteria applied.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Contact Alcon Call Center for Trial Locations	Fort Worth	Texas	United States	76134

Sponsors and Collaborators

• Alcon Research

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Alcon Research
• ClinicalTrials.gov Identifier: NCT00759941
• Other Study ID Numbers: SMA-07-08
• First Posted: Sep 25, 2008
• Last Update Posted: Jan 13, 2014
• Last Verified: Jul 1, 2012

• Keywords provided by Alcon Research: Glaucoma
• Additional relevant MeSH terms: Glaucoma; Pharmaceutical Solutions; Latanoprost; Ophthalmic Solutions; Brinzolamide

Study Results

Participant Flow

Recruitment Details	Eligible glaucoma patients were recruited and enrolled from 7 US study sites between Oct 15, 2007 and April 06, 2009.
Pre-assignment Detail	This reporting group includes all enrolled subjects.

Arm/Group Title	Xalatan + Azopt	Xalatan + Placebo
Arm/Group Description	Xalatan dosed once a day at 10 pm, with Azopt dosed three times a day at 8 AM, 2 PM, and 10:05 PM as an adjunctive therapy for 3 months.	Xalatan dosed once a day at 10 pm, with placebo dosed three times a day at 8 AM, 2 PM, and 10:05 PM concomitantly for 3 months.
Period Title: Overall Study
STARTED	42	44
COMPLETED	39	43
NOT COMPLETED	3	1

Baseline Characteristics

Arm/Group Title	Xalatan + Azopt	Xalatan + Placebo	Total
Arm/Group Description	Xalatan dosed once a day at 10 pm, with Azopt dosed three times a day at 8 AM, 2 PM, and 10:05 PM as an adjunctive therapy for 3 months.	Xalatan dosed once a day at 10 pm, with placebo dosed three times a day at 8 AM, 2 PM, and 10:05 PM concomitantly for 3 months.	Total of all reporting groups
Overall Participants	42	44	86
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	62.90 (11.43)	68.13 (11.59)	65.58 (11.75)
Sex: Female, Male (Count of Participants)
Female	27 64.3%	25 56.8%	52 60.5%
Male	15 35.7%	19 43.2%	34 39.5%

Outcome Measures

1. Primary Outcome

Title	Mean Change From Baseline in Intraocular Pressure, 8 AM, at 3 Months
Description	Intraocular pressure was measured by Goldmann applanation tonometry. A negative number indicated a reduction in intraocular pressure.
Time Frame	Day 0, 3 months

Outcome Measure Data

Analysis Population Description

All enrolled. Two subjects were excluded from the efficacy analysis due to an adverse event (1) and use of medication not permitted (1).

Arm/Group Title	Xalatan + Azopt	Xalatan + Placebo
Arm/Group Description	Xalatan dosed once a day at 10 pm, with Azopt dosed three times a day at 8 AM, 2 PM, and 10:05 PM as an adjunctive therapy for 3 months.	Xalatan dosed once a day at 10 pm, with placebo dosed three times a day at 8 AM, 2 PM, and 10:05 PM concomitantly for 3 months.
Measure Participants	40	44
Mean (Standard Deviation) [mmHg]	-3.13 (3.03)	-2.57 (2.63)

2. Primary Outcome

Title	Mean Change From Baseline in Intraocular Pressure, 12 PM, at 3 Months
Description	Intraocular pressure was measured by Goldmann applanation tonometry. A negative number indicated a reduction in intraocular pressure.
Time Frame	Day 0, 3 months

Outcome Measure Data

Analysis Population Description

All enrolled. Two subjects were excluded from the efficacy analysis due to an adverse event (1) and use of medication not permitted (1).

Arm/Group Title	Xalatan + Azopt	Xalatan + Placebo
Arm/Group Description	Xalatan dosed once a day at 10 pm, with Azopt dosed three times a day at 8 AM, 2 PM, and 10:05 PM as an adjunctive therapy for 3 months.	Xalatan dosed once a day at 10 pm, with placebo dosed three times a day at 8 AM, 2 PM, and 10:05 PM concomitantly for 3 months.
Measure Participants	40	44
Mean (Standard Deviation) [mmHg]	-3.30 (2.36)	-2.48 (2.92)

3. Primary Outcome

Title	Mean Change From Baseline in Intraocular Pressure, 4 PM, at 3 Months
Description	Intraocular pressure was measured by Goldmann applanation tonometry. A negative number indicated a reduction in intraocular pressure.
Time Frame	Day 0, 3 months

Outcome Measure Data

Analysis Population Description

All enrolled. Two subjects were excluded from the efficacy analysis due to an adverse event (1) and use of medication not permitted (1).

Arm/Group Title	Xalatan + Azopt	Xalatan + Placebo
Arm/Group Description	Xalatan dosed once a day at 10 pm, with Azopt dosed three times a day at 8 AM, 2 PM, and 10:05 PM as an adjunctive therapy for 3 months.	Xalatan dosed once a day at 10 pm, with placebo dosed three times a day at 8 AM, 2 PM, and 10:05 PM concomitantly for 3 months.
Measure Participants	40	44
Mean (Standard Deviation) [mmHg]	-3.00 (3.40)	-2.33 (3.18)

4. Primary Outcome

Title	Mean Change From Baseline in Intraocular Pressure, Diurnal, at 3 Months
Description	Diurnal intraocular pressure is the mean of the three timepoints measured (8AM, 12PM & 4PM). Intraocular pressure was measured by Goldmann applanation tonometry. A negative number indicated a reduction in mean intraocular pressure.
Time Frame	Day 0, 3 months

Outcome Measure Data

Analysis Population Description

All enrolled. Two subjects were excluded from the efficacy analysis due to an adverse event (1) and use of medication not permitted (1).

Arm/Group Title	Xalatan + Azopt	Xalatan + Placebo
Arm/Group Description	Xalatan dosed once a day at 10 pm, with Azopt dosed three times a day at 8 AM, 2 PM, and 10:05 PM as an adjunctive therapy for 3 months.	Xalatan dosed once a day at 10 pm, with placebo dosed three times a day at 8 AM, 2 PM, and 10:05 PM concomitantly for 3 months.
Measure Participants	40	44
Mean (Standard Deviation) [mmHg]	-3.20 (2.55)	-2.48 (2.37)

Adverse Events

Time Frame	Adverse events were collected for the duration of the study: 15-OCT-2007 to 31-JUL-2009.
Adverse Event Reporting Description	The safety population included all enrolled and exposed subjects.
Arm/Group Title	Xalatan + Azopt		Xalatan + Placebo
Arm/Group Description	Xalatan dosed once a day at 10 pm, with Azopt dosed three times a day at 8 AM, 2 PM, and 10:05 PM as an adjunctive therapy for 3 months.		Xalatan dosed once a day at 10 pm, with placebo dosed three times a day at 8 AM, 2 PM, and 10:05 PM concomitantly for 3 months.
All Cause Mortality
	Xalatan + Azopt		Xalatan + Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Xalatan + Azopt		Xalatan + Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/42 (0%)		0/44 (0%)
Other (Not Including Serious) Adverse Events
	Xalatan + Azopt		Xalatan + Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/42 (0%)		0/44 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

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

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