Glaucoma
Conditions
Keywords
Glaucoma
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.
Interventions
DRUGBrinzolamide 1% ophthalmic solution (Azopt)
One drop three times a day in both eyes for 3 months
One drop three times a day in both eyes for 3 months
One drop once a day in both eyes for 3 months
Sponsors
Alcon Research
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
35 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| 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. |
| 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. |
Countries
United States
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 details
This reporting group includes all enrolled subjects.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 42 |
| 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. | 44 |
| Total | 86 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 1 | 0 |
| Overall Study | Exited in error by site | 1 | 1 |
| Overall Study | Use of medication | 1 | 0 |
Baseline characteristics
| Characteristic | Xalatan + Azopt | Xalatan + Placebo | Total |
|---|---|---|---|
| Age, Continuous | 62.90 years STANDARD_DEVIATION 11.43 | 68.13 years STANDARD_DEVIATION 11.59 | 65.58 years STANDARD_DEVIATION 11.75 |
| Sex: Female, Male Female | 27 Participants | 25 Participants | 52 Participants |
| Sex: Female, Male Male | 15 Participants | 19 Participants | 34 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 42 | 0 / 44 |
| serious Total, serious adverse events | 0 / 42 | 0 / 44 |
Outcome results
Primary
Mean Change From Baseline in Intraocular Pressure, 12 PM, at 3 Months
Intraocular pressure was measured by Goldmann applanation tonometry. A negative number indicated a reduction in intraocular pressure.
Time frame: Day 0, 3 months
Population: All enrolled. Two subjects were excluded from the efficacy analysis due to an adverse event (1) and use of medication not permitted (1).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Xalatan + Azopt | Mean Change From Baseline in Intraocular Pressure, 12 PM, at 3 Months | -3.30 mmHg | Standard Deviation 2.36 |
| Xalatan + Placebo | Mean Change From Baseline in Intraocular Pressure, 12 PM, at 3 Months | -2.48 mmHg | Standard Deviation 2.92 |
Primary
Mean Change From Baseline in Intraocular Pressure, 4 PM, at 3 Months
Intraocular pressure was measured by Goldmann applanation tonometry. A negative number indicated a reduction in intraocular pressure.
Time frame: Day 0, 3 months
Population: All enrolled. Two subjects were excluded from the efficacy analysis due to an adverse event (1) and use of medication not permitted (1).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Xalatan + Azopt | Mean Change From Baseline in Intraocular Pressure, 4 PM, at 3 Months | -3.00 mmHg | Standard Deviation 3.4 |
| Xalatan + Placebo | Mean Change From Baseline in Intraocular Pressure, 4 PM, at 3 Months | -2.33 mmHg | Standard Deviation 3.18 |
Primary
Mean Change From Baseline in Intraocular Pressure, 8 AM, at 3 Months
Intraocular pressure was measured by Goldmann applanation tonometry. A negative number indicated a reduction in intraocular pressure.
Time frame: Day 0, 3 months
Population: All enrolled. Two subjects were excluded from the efficacy analysis due to an adverse event (1) and use of medication not permitted (1).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Xalatan + Azopt | Mean Change From Baseline in Intraocular Pressure, 8 AM, at 3 Months | -3.13 mmHg | Standard Deviation 3.03 |
| Xalatan + Placebo | Mean Change From Baseline in Intraocular Pressure, 8 AM, at 3 Months | -2.57 mmHg | Standard Deviation 2.63 |
Primary
Mean Change From Baseline in Intraocular Pressure, Diurnal, at 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.
Time frame: Day 0, 3 months
Population: All enrolled. Two subjects were excluded from the efficacy analysis due to an adverse event (1) and use of medication not permitted (1).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Xalatan + Azopt | Mean Change From Baseline in Intraocular Pressure, Diurnal, at 3 Months | -3.20 mmHg | Standard Deviation 2.55 |
| Xalatan + Placebo | Mean Change From Baseline in Intraocular Pressure, Diurnal, at 3 Months | -2.48 mmHg | Standard Deviation 2.37 |