Trial Outcomes & Findings for How Similar Are Changes to the Surface of the Eye When Two Different Glaucoma Eye Drops Are Used? (NCT NCT00798694)
NCT ID: NCT00798694
Last Updated: 2018-07-12
Results Overview
Difference of tear break up time (in seconds, average of 3 measurements) at one and two months after enrollment.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
58 participants
Primary outcome timeframe
Baseline, 1 month, 2 months
Results posted on
2018-07-12
Participant Flow
Participant milestones
| Measure |
Group 1 (New to Meds)
Naive to glaucoma therapy medical or surgical. These patients have never used eye drops to lower eye pressure. All patients will receive Xalatan in the right eye and Travatan Z in the left eye.
Xalatan: one drop of Xalatan Ophthalmic Solution instilled in right eye at bedtime
Travatan Z: one drop of Travatan Z Ophthalmic Solution instilled in left eye at bedtime
|
Group 2 (Currently on Xalatan)
Patients currently on Xalatan at least one month. These patients have been using Xalatan at least one month to lower their eye pressure. All patients will receive Xalatan in the right eye and Travatan Z in the left eye.
Xalatan: one drop of Xalatan Ophthalmic Solution instilled in right eye at bedtime
Travatan Z: one drop of Travatan Z Ophthalmic Solution instilled in left eye at bedtime
|
|---|---|---|
|
Overall Study
STARTED
|
30
|
28
|
|
Overall Study
COMPLETED
|
28
|
27
|
|
Overall Study
NOT COMPLETED
|
2
|
1
|
Reasons for withdrawal
| Measure |
Group 1 (New to Meds)
Naive to glaucoma therapy medical or surgical. These patients have never used eye drops to lower eye pressure. All patients will receive Xalatan in the right eye and Travatan Z in the left eye.
Xalatan: one drop of Xalatan Ophthalmic Solution instilled in right eye at bedtime
Travatan Z: one drop of Travatan Z Ophthalmic Solution instilled in left eye at bedtime
|
Group 2 (Currently on Xalatan)
Patients currently on Xalatan at least one month. These patients have been using Xalatan at least one month to lower their eye pressure. All patients will receive Xalatan in the right eye and Travatan Z in the left eye.
Xalatan: one drop of Xalatan Ophthalmic Solution instilled in right eye at bedtime
Travatan Z: one drop of Travatan Z Ophthalmic Solution instilled in left eye at bedtime
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
1
|
|
Overall Study
Physician Decision
|
1
|
0
|
Baseline Characteristics
How Similar Are Changes to the Surface of the Eye When Two Different Glaucoma Eye Drops Are Used?
Baseline characteristics by cohort
| Measure |
Group 1 (New to Meds)
n=28 Participants
Naive to glaucoma therapy medical or surgical. All patients will receive Xalatan in the right eye and Travatan Z in the left eye.
Xalatan: one drop of Xalatan Ophthalmic Solution instilled in right eye at bedtime
Travatan Z: one drop of Travatan Z Ophthalmic Solution instilled in left eye at bedtime
|
Group 2 (Currently on Xalatan)
n=27 Participants
Patients currently on Xalatan at least one month. All patients will receive Xalatan in the right eye and Travatan Z in the left eye.
Xalatan: one drop of Xalatan Ophthalmic Solution instilled in right eye at bedtime
Travatan Z: one drop of Travatan Z Ophthalmic Solution instilled in left eye at bedtime
|
Total
n=55 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
61.6 years
STANDARD_DEVIATION 11.7 • n=5 Participants
|
61.2 years
STANDARD_DEVIATION 13.2 • n=7 Participants
|
61.4 years
STANDARD_DEVIATION 12.4 • n=5 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
29 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
15 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
25 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
50 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
10 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
15 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
32 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
28 participants
n=5 Participants
|
27 participants
n=7 Participants
|
55 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline, 1 month, 2 monthsPopulation: Both eyes combined change from baseline.
Difference of tear break up time (in seconds, average of 3 measurements) at one and two months after enrollment.
Outcome measures
| Measure |
New to Meds
n=28 Participants
Naive to glaucoma therapy medical or surgical. All patients will receive Xalatan in the right eye and Travatan Z in the left eye.
Xalatan: one drop of Xalatan Ophthalmic Solution instilled in right eye at bedtime
Travatan Z: one drop of Travatan Z Ophthalmic Solution instilled in left eye at bedtime
A geometric mean ratio of 1 indicates equivalence of the two geometric means.
|
Currently on Xalatan
n=27 Participants
Patients currently on Xalatan at least one month. All patients will receive Xalatan in the right eye and Travatan Z in the left eye.
Xalatan: one drop of Xalatan Ophthalmic Solution instilled in right eye at bedtime
Travatan Z: one drop of Travatan Z Ophthalmic Solution instilled in left eye at bedtime
|
Group 2 Xalatan
27 patients - Eye using Xalatan (latanoprost with benzalkonium chloride)
|
Group 2 Travatan Z
27 patients - Eye using Travatan Z (travoprost with SofZia)
|
|---|---|---|---|---|
|
Change in Tear Break up Time (TBUT)
1 month
|
-0.86 seconds
Standard Deviation 6.09
|
-0.59 seconds
Standard Deviation 4.70
|
—
|
—
|
|
Change in Tear Break up Time (TBUT)
2 months
|
-2.00 seconds
Standard Deviation 5.42
|
0.27 seconds
Standard Deviation 4.72
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, 1 month, 2 monthsTear production, measured by Schirmer test in millimeters
Outcome measures
| Measure |
New to Meds
n=28 Participants
Naive to glaucoma therapy medical or surgical. All patients will receive Xalatan in the right eye and Travatan Z in the left eye.
Xalatan: one drop of Xalatan Ophthalmic Solution instilled in right eye at bedtime
Travatan Z: one drop of Travatan Z Ophthalmic Solution instilled in left eye at bedtime
A geometric mean ratio of 1 indicates equivalence of the two geometric means.
|
Currently on Xalatan
n=27 Participants
Patients currently on Xalatan at least one month. All patients will receive Xalatan in the right eye and Travatan Z in the left eye.
Xalatan: one drop of Xalatan Ophthalmic Solution instilled in right eye at bedtime
Travatan Z: one drop of Travatan Z Ophthalmic Solution instilled in left eye at bedtime
|
Group 2 Xalatan
27 patients - Eye using Xalatan (latanoprost with benzalkonium chloride)
|
Group 2 Travatan Z
27 patients - Eye using Travatan Z (travoprost with SofZia)
|
|---|---|---|---|---|
|
Tear Production
2 months
|
23.0 millimeters
Standard Deviation 9.35
|
17.4 millimeters
Standard Deviation 9.8
|
—
|
—
|
|
Tear Production
Baseline
|
22.4 millimeters
Standard Deviation 8.7
|
17.1 millimeters
Standard Deviation 9.3
|
—
|
—
|
|
Tear Production
1 month
|
21.1 millimeters
Standard Deviation 9.6
|
17.4 millimeters
Standard Deviation 9.0
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, 1 month, 2 monthsPopulation: One eye per participant in each Arm
Conjunctival hyperemia is the amount of redness on the white part of the eye. A total score was obtained by the sum of assessments in 6 areas of each eye are which are scored from 0 to 3 (0 = no redness; 3 = severe redness), then summed per eye for a total score range of 0-18 (0 = no redness; 18 = severe redness).
Outcome measures
| Measure |
New to Meds
n=28 Participants
Naive to glaucoma therapy medical or surgical. All patients will receive Xalatan in the right eye and Travatan Z in the left eye.
Xalatan: one drop of Xalatan Ophthalmic Solution instilled in right eye at bedtime
Travatan Z: one drop of Travatan Z Ophthalmic Solution instilled in left eye at bedtime
A geometric mean ratio of 1 indicates equivalence of the two geometric means.
|
Currently on Xalatan
n=28 Participants
Patients currently on Xalatan at least one month. All patients will receive Xalatan in the right eye and Travatan Z in the left eye.
Xalatan: one drop of Xalatan Ophthalmic Solution instilled in right eye at bedtime
Travatan Z: one drop of Travatan Z Ophthalmic Solution instilled in left eye at bedtime
|
Group 2 Xalatan
n=27 Participants
27 patients - Eye using Xalatan (latanoprost with benzalkonium chloride)
|
Group 2 Travatan Z
n=27 Participants
27 patients - Eye using Travatan Z (travoprost with SofZia)
|
|---|---|---|---|---|
|
Conjunctival Hyperemia Score
Baseline
|
4.0 units on a scale
Standard Deviation 2.7
|
4.6 units on a scale
Standard Deviation 3.3
|
3.2 units on a scale
Standard Deviation 2.6
|
3.6 units on a scale
Standard Deviation 3.2
|
|
Conjunctival Hyperemia Score
1 month
|
4.0 units on a scale
Standard Deviation 2.7
|
4.6 units on a scale
Standard Deviation 3.3
|
3.4 units on a scale
Standard Deviation 2.5
|
4.8 units on a scale
Standard Deviation 3.2
|
|
Conjunctival Hyperemia Score
2 months
|
4.0 units on a scale
Standard Deviation 3.5
|
5.3 units on a scale
Standard Deviation 3.7
|
3.3 units on a scale
Standard Deviation 3.3
|
4.0 units on a scale
Standard Deviation 3.8
|
SECONDARY outcome
Timeframe: Baseline, 1 month, 2 monthsIntraocular pressure (the fluid pressure inside the eye) was measured two times in each eye using the Goldman applanation tonometer and averaged.
Outcome measures
| Measure |
New to Meds
n=28 Participants
Naive to glaucoma therapy medical or surgical. All patients will receive Xalatan in the right eye and Travatan Z in the left eye.
Xalatan: one drop of Xalatan Ophthalmic Solution instilled in right eye at bedtime
Travatan Z: one drop of Travatan Z Ophthalmic Solution instilled in left eye at bedtime
A geometric mean ratio of 1 indicates equivalence of the two geometric means.
|
Currently on Xalatan
n=28 Participants
Patients currently on Xalatan at least one month. All patients will receive Xalatan in the right eye and Travatan Z in the left eye.
Xalatan: one drop of Xalatan Ophthalmic Solution instilled in right eye at bedtime
Travatan Z: one drop of Travatan Z Ophthalmic Solution instilled in left eye at bedtime
|
Group 2 Xalatan
n=27 Participants
27 patients - Eye using Xalatan (latanoprost with benzalkonium chloride)
|
Group 2 Travatan Z
n=27 Participants
27 patients - Eye using Travatan Z (travoprost with SofZia)
|
|---|---|---|---|---|
|
Intraocular Pressure
2 months
|
14.6 mmHg
Standard Deviation 3.7
|
15.2 mmHg
Standard Deviation 3.8
|
14.6 mmHg
Standard Deviation 3.3
|
14.3 mmHg
Standard Deviation 3.3
|
|
Intraocular Pressure
Baseline
|
20.9 mmHg
Standard Deviation 7.1
|
20.1 mmHg
Standard Deviation 6.3
|
14.8 mmHg
Standard Deviation 2.7
|
15.0 mmHg
Standard Deviation 3.3
|
|
Intraocular Pressure
1 month
|
15.6 mmHg
Standard Deviation 3.8
|
15.5 mmHg
Standard Deviation 3.4
|
15.1 mmHg
Standard Deviation 2.8
|
14.5 mmHg
Standard Deviation 2.8
|
SECONDARY outcome
Timeframe: Baseline, 1 month, 2 monthsOcular Surface Disease Index Scores (OSDI) were obtained from a 12-item validated OSDI questionnaire completed by each participant. This is an assessment related to eye comfort. Each question's score ranges from 0 = no disability to 4 = greatest disability. The total score is multiplied by 25 then divided by the number of questions answered then matched to a grid ranging from 0 to 100 with 0 having symptoms reported none of the time versus 100 having disability symptoms reported all of the time.
Outcome measures
| Measure |
New to Meds
n=28 Participants
Naive to glaucoma therapy medical or surgical. All patients will receive Xalatan in the right eye and Travatan Z in the left eye.
Xalatan: one drop of Xalatan Ophthalmic Solution instilled in right eye at bedtime
Travatan Z: one drop of Travatan Z Ophthalmic Solution instilled in left eye at bedtime
A geometric mean ratio of 1 indicates equivalence of the two geometric means.
|
Currently on Xalatan
n=28 Participants
Patients currently on Xalatan at least one month. All patients will receive Xalatan in the right eye and Travatan Z in the left eye.
Xalatan: one drop of Xalatan Ophthalmic Solution instilled in right eye at bedtime
Travatan Z: one drop of Travatan Z Ophthalmic Solution instilled in left eye at bedtime
|
Group 2 Xalatan
n=27 Participants
27 patients - Eye using Xalatan (latanoprost with benzalkonium chloride)
|
Group 2 Travatan Z
n=27 Participants
27 patients - Eye using Travatan Z (travoprost with SofZia)
|
|---|---|---|---|---|
|
Ocular Surface Disease Index Score
Baseline
|
10.8 scores on a scale
Standard Deviation 14.7
|
11.7 scores on a scale
Standard Deviation 14.2
|
9.8 scores on a scale
Standard Deviation 11.4
|
14.2 scores on a scale
Standard Deviation 17.7
|
|
Ocular Surface Disease Index Score
1 month
|
10.8 scores on a scale
Standard Deviation 14.7
|
11.7 scores on a scale
Standard Deviation 14.2
|
7.0 scores on a scale
Standard Deviation 6.9
|
8.1 scores on a scale
Standard Deviation 7.7
|
|
Ocular Surface Disease Index Score
2 months
|
11.1 scores on a scale
Standard Deviation 11.9
|
11.8 scores on a scale
Standard Deviation 11.6
|
6.6 scores on a scale
Standard Deviation 8.7
|
11.2 scores on a scale
Standard Deviation 18.3
|
SECONDARY outcome
Timeframe: Baseline, 1 month, 2 monthsPopulation: One eye from each patient per arm.
Corneal staining is an indication of the amount of dryness of the cornea (front clear part of the eye). A total score was obtained by the sum of assessments in five areas of each eye which are scored from 0 to 3 (0 = no dryness; 3 = severe dryness), then summed per eye for a total score range of 0-15 (0 = no dryness; 15 = severe dryness).
Outcome measures
| Measure |
New to Meds
n=28 Participants
Naive to glaucoma therapy medical or surgical. All patients will receive Xalatan in the right eye and Travatan Z in the left eye.
Xalatan: one drop of Xalatan Ophthalmic Solution instilled in right eye at bedtime
Travatan Z: one drop of Travatan Z Ophthalmic Solution instilled in left eye at bedtime
A geometric mean ratio of 1 indicates equivalence of the two geometric means.
|
Currently on Xalatan
n=28 Participants
Patients currently on Xalatan at least one month. All patients will receive Xalatan in the right eye and Travatan Z in the left eye.
Xalatan: one drop of Xalatan Ophthalmic Solution instilled in right eye at bedtime
Travatan Z: one drop of Travatan Z Ophthalmic Solution instilled in left eye at bedtime
|
Group 2 Xalatan
n=27 Participants
27 patients - Eye using Xalatan (latanoprost with benzalkonium chloride)
|
Group 2 Travatan Z
n=27 Participants
27 patients - Eye using Travatan Z (travoprost with SofZia)
|
|---|---|---|---|---|
|
Corneal Staining Score
Baseline
|
0.7 scores on a scale
Standard Deviation 1.0
|
0.8 scores on a scale
Standard Deviation 1.0
|
1.0 scores on a scale
Standard Deviation 1.9
|
1.0 scores on a scale
Standard Deviation 1.8
|
|
Corneal Staining Score
1 month
|
0.7 scores on a scale
Standard Deviation 1.0
|
0.8 scores on a scale
Standard Deviation 1.0
|
1.3 scores on a scale
Standard Deviation 2.0
|
1.2 scores on a scale
Standard Deviation 1.6
|
|
Corneal Staining Score
2 months
|
1.0 scores on a scale
Standard Deviation 2.0
|
1.3 scores on a scale
Standard Deviation 1.9
|
1.0 scores on a scale
Standard Deviation 1.5
|
1.0 scores on a scale
Standard Deviation 0.9
|
Adverse Events
New to Meds
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Currently on Xalatan
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
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
- Publication restrictions are in place