A Phase 4 interventional study of Brinzolamide 1% ophthalmic solution (Azopt) and Placebo eye drops in Glaucoma, sponsored by Alcon Research. Completed at 1 site in United States. Open to participants aged 35 Years and older. Per ClinicalTrials.gov, last updated 2014-01-13.
Sponsored by Alcon Research · Phase 4, Interventional, and Treatment
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.
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This study's enrollment of 86 is above the median of 65 across 1,272 interventional studies indexed under Glaucoma.
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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) · Drug: Latanoprost 0.005% ophthalmic solution (Xalatan)
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 · Drug: Latanoprost 0.005% ophthalmic solution (Xalatan)
One drop three times a day in both eyes for 3 months
Also known as: AZOPT
One drop three times a day in both eyes for 3 months
One drop once a day in both eyes for 3 months
Also known as: Xalatan
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
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
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
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
Eligible glaucoma patients were recruited and enrolled from 7 US study sites between Oct 15, 2007 and April 06, 2009.
| Milestone | Xalatan + Azopt | Xalatan + Placebo |
|---|---|---|
| Started | 42 | 44 |
| Completed | 39 | 43 |
| Not completed | 3 | 1 |
| Withdrew: Use of medication | 1 | 0 |
| Withdrew: Adverse event | 1 | 0 |
| Withdrew: Exited in error by site | 1 | 1 |
Intraocular pressure was measured by Goldmann applanation tonometry. A negative number indicated a reduction in intraocular pressure.
| mmHg | Xalatan + Azopt | Xalatan + Placebo |
|---|---|---|
| Mean Change From Baseline in Intraocular Pressure, 8 AM, at 3 Months | -3.13 ± 3.03 | -2.57 ± 2.63 |
Intraocular pressure was measured by Goldmann applanation tonometry. A negative number indicated a reduction in intraocular pressure.
| mmHg | Xalatan + Azopt | Xalatan + Placebo |
|---|---|---|
| Mean Change From Baseline in Intraocular Pressure, 12 PM, at 3 Months | -3.30 ± 2.36 | -2.48 ± 2.92 |
Intraocular pressure was measured by Goldmann applanation tonometry. A negative number indicated a reduction in intraocular pressure.
| mmHg | Xalatan + Azopt | Xalatan + Placebo |
|---|---|---|
| Mean Change From Baseline in Intraocular Pressure, 4 PM, at 3 Months | -3.00 ± 3.40 | -2.33 ± 3.18 |
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.
| mmHg | Xalatan + Azopt | Xalatan + Placebo |
|---|---|---|
| Mean Change From Baseline in Intraocular Pressure, Diurnal, at 3 Months | -3.20 ± 2.55 | -2.48 ± 2.37 |
Collected over Adverse events were collected for the duration of the study: 15-OCT-2007 to 31-JUL-2009.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Xalatan + Azopt | — | 0/42 (0%) | 0/42 (0%) |
| Xalatan + Placebo | — | 0/44 (0%) | 0/44 (0%) |
| Age, Continuous(years) | Xalatan + Azopt | Xalatan + Placebo | Total |
|---|---|---|---|
| Mean | 62.90 ± 11.43 | 68.13 ± 11.59 | 65.58 ± 11.75 |
| Sex: Female, Male(Participants) | Xalatan + Azopt | Xalatan + Placebo | Total |
|---|---|---|---|
| Female | 27 | 25 | 52 |
| Male | 15 | 19 | 34 |
This study is completed, as verified in Jul 2012. You cannot join it, but the record below documents what was studied.
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