Trial Outcomes & Findings for A Comparison of Azopt Versus Placebo Added to Xalatan in Patients With Elevated Intraocular Pressure (IOP) on a Prostaglandin (NCT NCT00759941)
NCT ID: NCT00759941
Last Updated: 2014-01-13
Results Overview
Intraocular pressure was measured by Goldmann applanation tonometry. A negative number indicated a reduction in intraocular pressure.
COMPLETED
PHASE4
86 participants
Day 0, 3 months
2014-01-13
Participant Flow
Eligible glaucoma patients were recruited and enrolled from 7 US study sites between Oct 15, 2007 and April 06, 2009.
This reporting group includes all enrolled subjects.
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
42
|
44
|
|
Overall Study
COMPLETED
|
39
|
43
|
|
Overall Study
NOT COMPLETED
|
3
|
1
|
Reasons for withdrawal
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
Use of medication
|
1
|
0
|
|
Overall Study
Adverse Event
|
1
|
0
|
|
Overall Study
Exited in error by site
|
1
|
1
|
Baseline Characteristics
A Comparison of Azopt Versus Placebo Added to Xalatan in Patients With Elevated Intraocular Pressure (IOP) on a Prostaglandin
Baseline characteristics by cohort
| Measure |
Xalatan + Azopt
n=42 Participants
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 + Placebo
n=44 Participants
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
n=86 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
62.90 years
STANDARD_DEVIATION 11.43 • n=99 Participants
|
68.13 years
STANDARD_DEVIATION 11.59 • n=107 Participants
|
65.58 years
STANDARD_DEVIATION 11.75 • n=206 Participants
|
|
Sex: Female, Male
Female
|
27 Participants
n=99 Participants
|
25 Participants
n=107 Participants
|
52 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
15 Participants
n=99 Participants
|
19 Participants
n=107 Participants
|
34 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Day 0, 3 monthsPopulation: All enrolled. Two subjects were excluded from the efficacy analysis due to an adverse event (1) and use of medication not permitted (1).
Intraocular pressure was measured by Goldmann applanation tonometry. A negative number indicated a reduction in intraocular pressure.
Outcome measures
| Measure |
Xalatan + Azopt
n=40 Participants
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 + Placebo
n=44 Participants
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.
|
|---|---|---|
|
Mean Change From Baseline in Intraocular Pressure, 8 AM, at 3 Months
|
-3.13 mmHg
Standard Deviation 3.03
|
-2.57 mmHg
Standard Deviation 2.63
|
PRIMARY outcome
Timeframe: Day 0, 3 monthsPopulation: All enrolled. Two subjects were excluded from the efficacy analysis due to an adverse event (1) and use of medication not permitted (1).
Intraocular pressure was measured by Goldmann applanation tonometry. A negative number indicated a reduction in intraocular pressure.
Outcome measures
| Measure |
Xalatan + Azopt
n=40 Participants
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 + Placebo
n=44 Participants
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.
|
|---|---|---|
|
Mean Change From Baseline in Intraocular Pressure, 12 PM, at 3 Months
|
-3.30 mmHg
Standard Deviation 2.36
|
-2.48 mmHg
Standard Deviation 2.92
|
PRIMARY outcome
Timeframe: Day 0, 3 monthsPopulation: All enrolled. Two subjects were excluded from the efficacy analysis due to an adverse event (1) and use of medication not permitted (1).
Intraocular pressure was measured by Goldmann applanation tonometry. A negative number indicated a reduction in intraocular pressure.
Outcome measures
| Measure |
Xalatan + Azopt
n=40 Participants
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 + Placebo
n=44 Participants
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.
|
|---|---|---|
|
Mean Change From Baseline in Intraocular Pressure, 4 PM, at 3 Months
|
-3.00 mmHg
Standard Deviation 3.40
|
-2.33 mmHg
Standard Deviation 3.18
|
PRIMARY outcome
Timeframe: Day 0, 3 monthsPopulation: All enrolled. Two subjects were excluded from the efficacy analysis due to an adverse event (1) and use of medication not permitted (1).
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.
Outcome measures
| Measure |
Xalatan + Azopt
n=40 Participants
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 + Placebo
n=44 Participants
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.
|
|---|---|---|
|
Mean Change From Baseline in Intraocular Pressure, Diurnal, at 3 Months
|
-3.20 mmHg
Standard Deviation 2.55
|
-2.48 mmHg
Standard Deviation 2.37
|
Adverse Events
Xalatan + Azopt
Xalatan + Placebo
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Alcon reserves the right of prior review of any publication or presentation of information related to the study.
- Publication restrictions are in place
Restriction type: OTHER