Trial Outcomes & Findings for Observational Study of the Long-term Effect of Latanoprost in Normal Tension Glaucoma (NCT NCT01209624)
NCT ID: NCT01209624
Last Updated: 2021-02-26
Results Overview
Mean IOP values measured by applanation tonometry or noncontact method; valid range: 8-40 millimeters of mercury (mmHg). Only the IOP reading for the eye treated with Xalatan® was used; if both eyes were treated, the value of the right eye was analyzed. Last visit = last post-baseline visit at which participant provides a value of IOP.
COMPLETED
902 participants
Baseline, Month 6, Month 12, Month 18, Month 24, Last Visit
2021-02-26
Participant Flow
In this prospective non-interventional study, participants did not actively participate in the study but were observed in general clinical practice by office-based ophthalmologists.
Participant milestones
| Measure |
Xalatan®
Once daily as 1 drop (topical application) in the evening
|
|---|---|
|
Overall Study
STARTED
|
902
|
|
Overall Study
Per Protocol Population
|
469
|
|
Overall Study
COMPLETED
|
576
|
|
Overall Study
NOT COMPLETED
|
326
|
Reasons for withdrawal
| Measure |
Xalatan®
Once daily as 1 drop (topical application) in the evening
|
|---|---|
|
Overall Study
Death
|
2
|
|
Overall Study
Adverse Event
|
13
|
|
Overall Study
Lack of Efficacy
|
17
|
|
Overall Study
Lost to Follow-up
|
290
|
|
Overall Study
Other
|
4
|
Baseline Characteristics
Observational Study of the Long-term Effect of Latanoprost in Normal Tension Glaucoma
Baseline characteristics by cohort
| Measure |
Xalatan®
n=902 Participants
Once daily as 1 drop (topical application) in the evening
|
|---|---|
|
Age, Customized
< 18 years
|
5 participants
13.1 • n=99 Participants
|
|
Age, Customized
18 to 44 years
|
68 participants
n=99 Participants
|
|
Age, Customized
45 to 64 years
|
281 participants
n=99 Participants
|
|
Age, Customized
>= 65 years
|
528 participants
n=99 Participants
|
|
Age, Customized
unspecified
|
20 participants
n=99 Participants
|
|
Sex/Gender, Customized
Female
|
545 participants
n=99 Participants
|
|
Sex/Gender, Customized
Male
|
347 participants
n=99 Participants
|
|
Sex/Gender, Customized
Unspecified
|
10 participants
n=99 Participants
|
|
Raw Intraocular Pressure
|
18.14 mmHg
STANDARD_DEVIATION 3.62 • n=99 Participants
|
|
Horizontal Cup to Disc Ratio
|
0.53 Ratio
STANDARD_DEVIATION 0.22 • n=99 Participants
|
|
Vertical Cup to Disc Ratio
|
0.56 Ratio
STANDARD_DEVIATION 0.22 • n=99 Participants
|
|
Rim Area
|
1.26 mm^2
STANDARD_DEVIATION 0.30 • n=99 Participants
|
|
Rim Volume
|
0.30 mm^3
STANDARD_DEVIATION 0.14 • n=99 Participants
|
|
Cup Shape Measure
|
-0.12 Cup shape measure
STANDARD_DEVIATION 0.09 • n=99 Participants
|
|
Retinal Nerve Fiber Layer Thickness
|
0.21 mm
STANDARD_DEVIATION 0.07 • n=99 Participants
|
|
Optic Disc Hemorrhage
|
21 Participants
n=99 Participants
|
PRIMARY outcome
Timeframe: Baseline, Month 6, Month 12, Month 18, Month 24, Last VisitPopulation: Per protocol (PP) analysis set: all participants in the Full Analysis Set (at least 1 dose of Xalatan® and 1 post-baseline IOP measurement) who were treated for ≥18 months; had at least BL and 1 post-BL non-missing efficacy assessments for IOP at least 18 months apart; without ametropy at BL; and without additional glaucoma medication during study.
Mean IOP values measured by applanation tonometry or noncontact method; valid range: 8-40 millimeters of mercury (mmHg). Only the IOP reading for the eye treated with Xalatan® was used; if both eyes were treated, the value of the right eye was analyzed. Last visit = last post-baseline visit at which participant provides a value of IOP.
Outcome measures
| Measure |
Xalatan®
n=469 Participants
Once daily as 1 drop (topical application) in the evening
|
|---|---|
|
Change From Baseline in Raw Intraocular Pressure (IOP) by Visit
Month 6
|
-3.20 mmHg
Standard Deviation 3.11
|
|
Change From Baseline in Raw Intraocular Pressure (IOP) by Visit
Month 12
|
-3.12 mmHg
Standard Deviation 3.35
|
|
Change From Baseline in Raw Intraocular Pressure (IOP) by Visit
Month 18
|
-3.22 mmHg
Standard Deviation 3.52
|
|
Change From Baseline in Raw Intraocular Pressure (IOP) by Visit
Month 24
|
-3.43 mmHg
Standard Deviation 3.51
|
|
Change From Baseline in Raw Intraocular Pressure (IOP) by Visit
Last Visit
|
-3.34 mmHg
Standard Deviation 3.59
|
PRIMARY outcome
Timeframe: Month 12Population: PP; N = number of participants with analyzable data at observation.
Response: Yes = had an IOP 24-hour profile; No = did not have an IOP 24-hour profile.
Outcome measures
| Measure |
Xalatan®
n=436 Participants
Once daily as 1 drop (topical application) in the evening
|
|---|---|
|
Number of Participants With a 24-Hour Intraocular Pressure (IOP) Profile: Month 12
Yes
|
60 Participants
|
|
Number of Participants With a 24-Hour Intraocular Pressure (IOP) Profile: Month 12
No
|
376 Participants
|
PRIMARY outcome
Timeframe: Month 24Population: PP; N = number of participants with analyzable data at observation.
Response: Yes = had an IOP 24-hour profile; No = did not have an IOP 24-hour profile.
Outcome measures
| Measure |
Xalatan®
n=423 Participants
Once daily as 1 drop (topical application) in the evening
|
|---|---|
|
Number of Participants With a 24-Hour Intraocular Pressure (IOP) Profile: Month 24
Yes
|
56 Participants
|
|
Number of Participants With a 24-Hour Intraocular Pressure (IOP) Profile: Month 24
No
|
367 Participants
|
PRIMARY outcome
Timeframe: Month 12Population: PP; N = number of participants with analyzable data at observation. The total number of participants by visit with an IOP peak response of 'Yes' differs from those with numerical values of IOP peaks since 1 of the 2 fields was populated for certain participants.
Response: Yes = had IOP 24-hour pressure peak; No = did not have IOP 24-hour pressure peak.
Outcome measures
| Measure |
Xalatan®
n=120 Participants
Once daily as 1 drop (topical application) in the evening
|
|---|---|
|
Number of Participants Per Visit With Intraocular Pressure (IOP) 24-Hour Pressure Peaks: Month 12
Yes
|
6 Participants
|
|
Number of Participants Per Visit With Intraocular Pressure (IOP) 24-Hour Pressure Peaks: Month 12
No
|
114 Participants
|
PRIMARY outcome
Timeframe: Month 24Population: PP; N = number of participants with analyzable data at observation. The total number of participants by visit with an IOP peak response of 'Yes' differs from those with numerical values of IOP peaks since 1 of the 2 fields was populated for certain participants.
Response: Yes = had IOP 24-hour pressure peak; No = did not have IOP 24-hour pressure peak.
Outcome measures
| Measure |
Xalatan®
n=107 Participants
Once daily as 1 drop (topical application) in the evening
|
|---|---|
|
Number of Participants Per Visit With Intraocular Pressure (IOP) 24-Hour Pressure Peaks: Month 24
Yes
|
6 Participants
|
|
Number of Participants Per Visit With Intraocular Pressure (IOP) 24-Hour Pressure Peaks: Month 24
No
|
101 Participants
|
PRIMARY outcome
Timeframe: Month 24, (or last visit)Population: PP; n = number of subjects in the Per Protocol Analysis Set with a non-missing response at Last Visit. Last visit = last post-baseline visit at which participant provides a value of IOP.
Percentage of participants who achieved their IOP target set at baseline. Response: Yes = achieved IOP target at last vist; No = did not achieve IOP target at last visit.
Outcome measures
| Measure |
Xalatan®
n=469 Participants
Once daily as 1 drop (topical application) in the evening
|
|---|---|
|
Percentage of Participants Who Achieved Intraocular Pressure (IOP) Target at Last Visit
Yes (n = 264)
|
56.3 Percentage of Participants
|
|
Percentage of Participants Who Achieved Intraocular Pressure (IOP) Target at Last Visit
No (n = 62)
|
13.2 Percentage of Participants
|
PRIMARY outcome
Timeframe: Baseline, Month 6, Month 12, Month 18, Month 24, Last VisitPopulation: PP; N = number of participants with horizontal cup to disc ratio data at baseline and at least 1 post-baseline visit; change analyzed for participants with a non-missing response at baseline and observation. Last Visit: change in participants with a non-missing response at both baseline and at least one post-baseline visit.
Mean horizontal cup to disc (cup/disc or C/D) ratio measured by slit lamp examination to assess progression of glaucoma; calculated as the ratio of the diameter of the depression (cup) to that of the optical nerve head (disc). Valid range: 0.1-1.0. Only data for the eye treated with Xalatan® was used; if both eyes were treated, the value of the right eye was analyzed.
Outcome measures
| Measure |
Xalatan®
n=394 Participants
Once daily as 1 drop (topical application) in the evening
|
|---|---|
|
Change From Baseline by Visit in Optic Disc Excavation: Horizontal Cup to Disc Ratio
Month 6
|
-0.00 Ratio
Standard Deviation 0.07
|
|
Change From Baseline by Visit in Optic Disc Excavation: Horizontal Cup to Disc Ratio
Month 12
|
0.00 Ratio
Standard Deviation 0.10
|
|
Change From Baseline by Visit in Optic Disc Excavation: Horizontal Cup to Disc Ratio
Month 18
|
0.01 Ratio
Standard Deviation 0.11
|
|
Change From Baseline by Visit in Optic Disc Excavation: Horizontal Cup to Disc Ratio
Month 24
|
0.01 Ratio
Standard Deviation 0.11
|
|
Change From Baseline by Visit in Optic Disc Excavation: Horizontal Cup to Disc Ratio
Last Visit
|
0.00 Ratio
Standard Deviation 0.12
|
PRIMARY outcome
Timeframe: Baseline, Month 6, Month 12, Month 18, Month 24, Last VisitPopulation: PP. N = number of participants with vertical cup to disc ratio at baseline and at least 1 post-baseline visit; change analyzed for participants with a non-missing response at baseline and observation. Last Visit: change in vertical cup to disc ratio in participants with a non-missing response at both baseline and at least one post-baseline visit.
Mean vertical cup to disc (cup/disc or C/D) ratio measured by slit lamp examination to assess progression of glaucoma; calculated as the ratio of the diameter of the depression (cup) to that of the optical nerve head (disc). Valid range: 0.1-1.0; a high cup/disc ratio may imply glaucoma. Only data for the eye treated with Xalatan® was used; if both eyes were treated, the value of the right eye was analyzed.
Outcome measures
| Measure |
Xalatan®
n=374 Participants
Once daily as 1 drop (topical application) in the evening
|
|---|---|
|
Change From Baseline by Visit in Optic Disc Excavation: Vertical Cup to Disc Ratio
Month 6
|
0.01 Ratio
Standard Deviation 0.08
|
|
Change From Baseline by Visit in Optic Disc Excavation: Vertical Cup to Disc Ratio
Month 12
|
0.01 Ratio
Standard Deviation 0.10
|
|
Change From Baseline by Visit in Optic Disc Excavation: Vertical Cup to Disc Ratio
Month 18
|
0.00 Ratio
Standard Deviation 0.11
|
|
Change From Baseline by Visit in Optic Disc Excavation: Vertical Cup to Disc Ratio
Month 24
|
0.01 Ratio
Standard Deviation 0.11
|
|
Change From Baseline by Visit in Optic Disc Excavation: Vertical Cup to Disc Ratio
Last Visit
|
0.00 Ratio
Standard Deviation 0.12
|
PRIMARY outcome
Timeframe: Month 6Population: PP; N = number of participants who indicated whether or not they had an optic disc hemorrhage at the given visit.
Presence of optic disc hemorrhages assessed by slip lamp examination. Only data for eye were treated with Xalatan® was used; if both eyes were treated, the value of the right eye was analyzed.
Outcome measures
| Measure |
Xalatan®
n=368 Participants
Once daily as 1 drop (topical application) in the evening
|
|---|---|
|
Number of Participants With Optic Disc Hemorrhage by Visit: Month 6
|
7 Participants
|
PRIMARY outcome
Timeframe: Month 12Population: PP; N = number of participants who indicated whether or not they had an optic disc hemorrhage at the given visit.
Presence of optic disc hemorrhages assessed by slip lamp examination. Only data for eye were treated with Xalatan® was used; if both eyes were treated, the value of the right eye was analyzed.
Outcome measures
| Measure |
Xalatan®
n=364 Participants
Once daily as 1 drop (topical application) in the evening
|
|---|---|
|
Number of Participants With Optic Disc Hemorrhage by Visit: Month 12
|
6 Participants
|
PRIMARY outcome
Timeframe: Month 18Population: PP; N = number of participants who indicated whether or not they had an optic disc hemorrhage at the given visit.
Presence of optic disc hemorrhages assessed by slip lamp examination. Only data for eye were treated with Xalatan® was used; if both eyes were treated, the value of the right eye was analyzed.
Outcome measures
| Measure |
Xalatan®
n=373 Participants
Once daily as 1 drop (topical application) in the evening
|
|---|---|
|
Number of Participants With Optic Disc Hemorrhage by Visit: Month 18
|
9 Participants
|
PRIMARY outcome
Timeframe: Month 24Population: PP; N = number of participants who indicated whether or not they had an optic disc hemorrhage at the given visit.
Presence of optic disc hemorrhages assessed by slip lamp examination. Only data for eye were treated with Xalatan® was used; if both eyes were treated, the value of the right eye was analyzed.
Outcome measures
| Measure |
Xalatan®
n=366 Participants
Once daily as 1 drop (topical application) in the evening
|
|---|---|
|
Number of Participants With Optic Disc Hemorrhage by Visit: Month 24
|
5 Participants
|
PRIMARY outcome
Timeframe: Baseline, Month 6, Month 12, Month 18, Month 24, Last VisitPopulation: PP; n = number of participants with a non-missing response at both visits (baseline and observation). Last Visit = last post-baseline visit at which participant provides a value for rim area.
Rim area (millimeter \[mm\]2) right and left eye assessed by HRT imaging. Valid range: 0.500 to 1.900 mm2. Only the rim area for the eye treated with Xalatan® was used; if both eyes were treated, the value of the right eye was analyzed.
Outcome measures
| Measure |
Xalatan®
n=469 Participants
Once daily as 1 drop (topical application) in the evening
|
|---|---|
|
Change From Baseline in Heidelberg Retina Tomograph (HRT) Parameters: Rim Area
Month 6 (n = 47)
|
-0.01 mm2
Standard Deviation 0.11
|
|
Change From Baseline in Heidelberg Retina Tomograph (HRT) Parameters: Rim Area
Month 12 (n = 65)
|
-0.01 mm2
Standard Deviation 0.15
|
|
Change From Baseline in Heidelberg Retina Tomograph (HRT) Parameters: Rim Area
Month 18 (n = 63)
|
-0.02 mm2
Standard Deviation 0.17
|
|
Change From Baseline in Heidelberg Retina Tomograph (HRT) Parameters: Rim Area
Month 24 (n = 70)
|
-0.03 mm2
Standard Deviation 0.16
|
|
Change From Baseline in Heidelberg Retina Tomograph (HRT) Parameters: Rim Area
Last Visit (n = 111)
|
-0.02 mm2
Standard Deviation 0.16
|
PRIMARY outcome
Timeframe: Baseline, Month 6, Month 12, Month 18, Month 24, Last VisitPopulation: PP; n = number of participants with a non-missing response at both visits (baseline and observation). Last Visit = last post-baseline visit at which participant provides a value for rim volume.
Rim volume (mm3) right and left eye assessed by HRT imaging. Valid range: 0.080 to 0.700 mm3. Only the rim volume for the eye treated with Xalatan® was used; if both eyes were treated, the value of the right eye was analyzed.
Outcome measures
| Measure |
Xalatan®
n=469 Participants
Once daily as 1 drop (topical application) in the evening
|
|---|---|
|
Change From Baseline in Heidelberg Retina Tomograph (HRT) Parameters: Rim Volume
Month 6 (n = 46)
|
0.01 mm3
Standard Deviation 0.06
|
|
Change From Baseline in Heidelberg Retina Tomograph (HRT) Parameters: Rim Volume
Month 12 (n = 65)
|
0.00 mm3
Standard Deviation 0.06
|
|
Change From Baseline in Heidelberg Retina Tomograph (HRT) Parameters: Rim Volume
Month 18 (n = 62)
|
0.01 mm3
Standard Deviation 0.11
|
|
Change From Baseline in Heidelberg Retina Tomograph (HRT) Parameters: Rim Volume
Month 24 (n = 70)
|
-0.00 mm3
Standard Deviation 0.05
|
|
Change From Baseline in Heidelberg Retina Tomograph (HRT) Parameters: Rim Volume
Last Visit (n = 112)
|
0.00 mm3
Standard Deviation 0.08
|
PRIMARY outcome
Timeframe: Baseline, Month 6, Month 12, Month 18, Month 24, Last VisitPopulation: PP; n = number of participants with a non-missing response at both visits (baseline and observation). Last Visit = last post-baseline visit at which participant provides a value for cup shape measure.
Cup shape measure right and left eye assessed by HRT imaging . Valid range: -0.400 to -0.010. Only the cup shape measure for the eye treated with Xalatan® was used; if both eyes were treated, the value of the right eye was analyzed.
Outcome measures
| Measure |
Xalatan®
n=469 Participants
Once daily as 1 drop (topical application) in the evening
|
|---|---|
|
Change From Baseline in Heidelberg Retina Tomograph Parameters: Cup Shape Measure
Month 6 (n = 47)
|
-0.00 Cup shape measure
Standard Deviation 0.02
|
|
Change From Baseline in Heidelberg Retina Tomograph Parameters: Cup Shape Measure
Month 12 (n = 69)
|
-0.00 Cup shape measure
Standard Deviation 0.04
|
|
Change From Baseline in Heidelberg Retina Tomograph Parameters: Cup Shape Measure
Month 18 (n = 65)
|
-0.00 Cup shape measure
Standard Deviation 0.05
|
|
Change From Baseline in Heidelberg Retina Tomograph Parameters: Cup Shape Measure
Month 24 (n = 71)
|
-0.01 Cup shape measure
Standard Deviation 0.04
|
|
Change From Baseline in Heidelberg Retina Tomograph Parameters: Cup Shape Measure
Last Visit (n = 113)
|
-0.00 Cup shape measure
Standard Deviation 0.05
|
PRIMARY outcome
Timeframe: Baseline, Month 6, Month 12, Month 18, Month 24, Last VisitPopulation: PP; n = number of participants with a non-missing response at both visits (baseline and observation). Last Visit = last post-baseline visit at which participant provides a value for RNFL thickness.
Mean retinal nerve fiber layer (RNFL) thickness in millimeters (mm) right and left eye assessed by HRT imaging. Valid range: 0.100 to 0.400 mm. Only the RNFL for the eye treated with Xalatan® was used; if both eyes were treated, the value of the right eye was analyzed.
Outcome measures
| Measure |
Xalatan®
n=469 Participants
Once daily as 1 drop (topical application) in the evening
|
|---|---|
|
Change From Baseline in Heidelberg Retina Tomograph (HRT) Parameters: Mean RNFL Thickness
Month 6 (n = 47)
|
-0.00 mm
Standard Deviation 0.03
|
|
Change From Baseline in Heidelberg Retina Tomograph (HRT) Parameters: Mean RNFL Thickness
Month 12 (n = 67)
|
-0.01 mm
Standard Deviation 0.04
|
|
Change From Baseline in Heidelberg Retina Tomograph (HRT) Parameters: Mean RNFL Thickness
Month 18 (n = 63)
|
-0.00 mm
Standard Deviation 0.05
|
|
Change From Baseline in Heidelberg Retina Tomograph (HRT) Parameters: Mean RNFL Thickness
Month 24 (n = 69)
|
0.00 mm
Standard Deviation 0.04
|
|
Change From Baseline in Heidelberg Retina Tomograph (HRT) Parameters: Mean RNFL Thickness
Last Visit (n = 110)
|
0.00 mm
Standard Deviation 0.05
|
PRIMARY outcome
Timeframe: Baseline, Month 24Population: PP; N = number of participants who provided Aulhorn stage values of 1 to 5 at both baseline and month 24 visits.
Values of change in Aulhorn Stage measured by Humphrey Visual Field Analyzer. Aulhorn stages: no scotoma, Stage I (relative scotomas only), Stage II (absolute scotomas without connection to blind spot), Stage III (absolute scotomas with connection to blind spot), Stage IV (absolute scotomas more than 1 quadrant affected), and Stage V (temporal residual visual field only). If both eyes were treated with Xalantan® the value of right eye was analyzed; otherwise, only the assessment for the eye treated with study medication was used.
Outcome measures
| Measure |
Xalatan®
n=62 Participants
Once daily as 1 drop (topical application) in the evening
|
|---|---|
|
Number of Participants With Change From Baseline to Month 24 in Aulhorn Stages
Change in Aulhorn Stage: -4
|
1 Participants
|
|
Number of Participants With Change From Baseline to Month 24 in Aulhorn Stages
Change in Aulhorn Stage: -3
|
2 Participants
|
|
Number of Participants With Change From Baseline to Month 24 in Aulhorn Stages
Change in Aulhorn Stage: -2
|
0 Participants
|
|
Number of Participants With Change From Baseline to Month 24 in Aulhorn Stages
Change in Aulhorn Stage: -1
|
6 Participants
|
|
Number of Participants With Change From Baseline to Month 24 in Aulhorn Stages
Change in Aulhorn Stage: 0
|
45 Participants
|
|
Number of Participants With Change From Baseline to Month 24 in Aulhorn Stages
Change in Aulhorn Stage: +1
|
6 Participants
|
|
Number of Participants With Change From Baseline to Month 24 in Aulhorn Stages
Change in Aulhorn Stage: +2
|
2 Participants
|
|
Number of Participants With Change From Baseline to Month 24 in Aulhorn Stages
Change in Aulhorn Stage: +3
|
0 Participants
|
|
Number of Participants With Change From Baseline to Month 24 in Aulhorn Stages
Change in Aulhorn Stage: +4
|
0 Participants
|
PRIMARY outcome
Timeframe: Baseline, Month 24Population: PP; N = number of participants who provided a Mean Defect value at both Baseline and Month 24 visits.
Change in mean defect right and left eye; valid range: -30 - + 30 decibels (dB). Visual field defect categories: preperimetric glaucoma: ≥ -2 dB; mild damage: \< -2 dB and ≥ -3.3 dB; moderate damage: \< -3.3 dB and ≥ -4.6 dB; and severe damage: \< -4.6 dB. If both eyes were treated with Xalatan® , the value for the right eye was used; otherwise, only the mean defect value for the eye treated with study medication was used.
Outcome measures
| Measure |
Xalatan®
n=138 Participants
Once daily as 1 drop (topical application) in the evening
|
|---|---|
|
Number of Participants With Change From Baseline to Month 24 in Visual Field Defect
Change in mean defect: < 0dB
|
60 Participants
|
|
Number of Participants With Change From Baseline to Month 24 in Visual Field Defect
Change in mean defect: 0 to < 0.5dB
|
31 Participants
|
|
Number of Participants With Change From Baseline to Month 24 in Visual Field Defect
Change in mean defect: ≥ 0.5dB to < 1.5dB
|
17 Participants
|
|
Number of Participants With Change From Baseline to Month 24 in Visual Field Defect
Change in mean defect: ≥ 1.5dB to < 2.5dB
|
12 Participants
|
|
Number of Participants With Change From Baseline to Month 24 in Visual Field Defect
Change in mean defect: ≥ 2.5dB to < 3.5dB
|
6 Participants
|
|
Number of Participants With Change From Baseline to Month 24 in Visual Field Defect
Change in mean defect: ≥ 3.5dB to < 4.5dB
|
5 Participants
|
|
Number of Participants With Change From Baseline to Month 24 in Visual Field Defect
Change in mean defect: ≥ 4.5dB
|
7 Participants
|
PRIMARY outcome
Timeframe: Month 24Population: PP; N = number of participants with a non-missing response at Month 24 visit.
Number of participants with Investigator assessments of the efficacy of Xalatan® treatment rated as: 1=very good, 2=good, 3=moderate, 4=insufficient. If study medication was stopped before 24 months, assessment was performed at the time of early termination.
Outcome measures
| Measure |
Xalatan®
n=442 Participants
Once daily as 1 drop (topical application) in the evening
|
|---|---|
|
Number of Participants With Investigator Assessments of Efficacy at Month 24
Very Good
|
269 Participants
|
|
Number of Participants With Investigator Assessments of Efficacy at Month 24
Good
|
147 Participants
|
|
Number of Participants With Investigator Assessments of Efficacy at Month 24
Moderate
|
24 Participants
|
|
Number of Participants With Investigator Assessments of Efficacy at Month 24
Insufficient
|
2 Participants
|
PRIMARY outcome
Timeframe: Month 24 (or last visit)Population: PP; results based on participants with both a Baseline and at least one post-baseline visit. Last Visit = last post-baseline visit at which participant provides a value for the relevant outcome measure.
Increase in Horizontal Cup to Disc Ratio and/or Vertical Cup to Disc Ratio by at least 0.2 (Last Visit minus Baseline).
Outcome measures
| Measure |
Xalatan®
n=469 Participants
Once daily as 1 drop (topical application) in the evening
|
|---|---|
|
Number of Participants With Individual Progression of Glaucoma Damage: Horizontal Cup to Disc Ratio and/or Vertical Cup to Disc Ratio
|
34 Participants
|
PRIMARY outcome
Timeframe: Month 24 (or last visit)Population: PP; results based on participants with at least one post-baseline assessment of optic disc hemorrhage. Last Visit = last post-baseline visit at which participant provides a value for the relevant outcome measure.
Participants with at least one post-baseline optic disc hemorrhage.
Outcome measures
| Measure |
Xalatan®
n=469 Participants
Once daily as 1 drop (topical application) in the evening
|
|---|---|
|
Number of Participants With Individual Progression of Glaucoma Damage: Optic Disc Hemorrhage
|
16 Particpants
|
PRIMARY outcome
Timeframe: Month 24 (or last visit)Population: PP; results based on participants with a value of the variable in question at both Baseline and at least one post-baseline visit. Last Visit = last post-baseline visit at which participant provides a value for the relevant outcome measure.
Decrease in at least one Heidelberg Retina Tomograph (HRT) parameter by: Rim Area 0.2 millimeter (mm)2, Rim Volume 0.1 mm3, or mean retinal nerve fiber layer (RNFL) Thickness 0.1 mm, (Last Visit minus Baseline).
Outcome measures
| Measure |
Xalatan®
n=469 Participants
Once daily as 1 drop (topical application) in the evening
|
|---|---|
|
Number of Participants With Individual Progression of Glaucoma Damage: Rim Area, Rim Volume, or Mean Retinal Nerve Fiber Layer (RNFL) Thickness
|
12 Participants
|
PRIMARY outcome
Timeframe: Month 24 (or last visit)Population: PP; results based on participants with at least one post-baseline assessment of change in visual field defect. Last Visit = last post-baseline visit at which participant provides a value for the relevant outcome measure.
Visual Field Deterioration rated as progressive by physician on at least one post-baseline visit; range: 1= improved 2= stable 3= progressive. If both eyes were treated with Xalatan® the value for the right eye was used; otherwise, only the assessment for the eye treated with study medication was used.
Outcome measures
| Measure |
Xalatan®
n=469 Participants
Once daily as 1 drop (topical application) in the evening
|
|---|---|
|
Number of Participants With Individual Progression of Glaucoma Damage: Visual Field Defect-Deterioration
|
51 Participants
|
PRIMARY outcome
Timeframe: Month 24 (or last visit)Population: PP; results based on participants with a value for Aulhorn Stage at both Baseline and at least one post-baseline visit. Last Visit = last post-baseline visit at which participant provides a value for the relevant outcome measure.
Increase in Aulhorn Stage by at least one stage (last visit minus baseline). Three different visual field defect categories defined using Aulhorn stage values 1-5: Aulhorn stage 1 = mild damage, Aulhorn stages 2, 3 = moderate damage, Aulhorn stages 4, 5 =severe damage.
Outcome measures
| Measure |
Xalatan®
n=469 Participants
Once daily as 1 drop (topical application) in the evening
|
|---|---|
|
Number of Participants With Individual Progression of Glaucoma Damage: Aulhorn Stage
|
20 Participants
|
PRIMARY outcome
Timeframe: Month 24 (or last visit)Population: PP; results based on participants with a value for mean defect at both Baseline and at least one post-baseline visit. Last Visit = last post-baseline visit at which participant provides a value for the relevant outcome measure.
Decrease in mean defect by at least 2.5 decibels (dB) (Last Visit minus Baseline).
Outcome measures
| Measure |
Xalatan®
n=469 Participants
Once daily as 1 drop (topical application) in the evening
|
|---|---|
|
Number of Participants With Individual Progression of Glaucoma Damage: Mean Defect
|
28 Participants
|
PRIMARY outcome
Timeframe: Month 24 (or last visit)Population: PP; to be included in the percentage, participants must have provided a response for at least one of the six individual progression of glaucoma damage measures. Last Visit = last post-baseline visit at which participant provides a value for the relevant outcome measure.
Overall progression defined as at least 1 of the 6 individual progression of glaucoma damage measures met: increase in horizontal cup to disc ratio and/or vertical cup to disc ratio by at least 0.2; at least 1 post Baseline (BL) optic-disc hemorrhage; decreased rim area (0.2 mm2), rim volume (0.1 mm3), mean retinal nerve fiber layer (RNFL)(0.1 mm), progressive visual field deterioration, increase in Aulhorn stage (by at least 1 stage), and/or decrease in mean defect by at least 2.5 decibels \[dB\])
Outcome measures
| Measure |
Xalatan®
n=469 Participants
Once daily as 1 drop (topical application) in the evening
|
|---|---|
|
Percentage of Participants With Overall Progression of Glaucoma Damage
|
25.8 Percentage of Participants
|
PRIMARY outcome
Timeframe: Month 24 (or last visit)Population: PP; to be included in the percentage, participants must have provided a response for at least one of following events: increase in horizontal or vertical cup to disc ratio, or decrease in rim area, rim volume, or mean RNFL thickness. Last Visit = last post-baseline visit at which participant provides a value for the relevant outcome measure.
Progression (Last Visit minus Baseline) defined as increase in horizontal cup to disc ratio and/or vertical cup to disc ratio by at least 0.2, and/or decrease in at least 1 of Heidelberg Retina Tomograph (HRT) parameters (deterioration of rim area 0.2 mm2; deterioration of rim volume 0.1 mm3 deterioration or mean retinal nerve fiber layer (RNFL) thickness 0.1 mm).
Outcome measures
| Measure |
Xalatan®
n=469 Participants
Once daily as 1 drop (topical application) in the evening
|
|---|---|
|
Percentage of Participants With Progression of Optic Disc Excavation
|
11.3 Percentage of Participants
|
PRIMARY outcome
Timeframe: Month 24 (or last visit)Population: PP; to be included in the percentage, participants must have had Visual Field Deterioration rated as progressive by the physician on at least 1 post-baseline visit, and at least one measure of increase in Aulhorn Stage by at least 1 stage, and decrease in Mean Defect by at least 2 dB (last visit minus baseline).
Progression defined as visual field deterioration rated progressive by physician on at least 1 post-baseline visit, and increase in Aulhorn stage (by at least 1 stage) and/or decrease in mean defect by at least 2.5 dB (Last Visit minus Baseline).
Outcome measures
| Measure |
Xalatan®
n=469 Participants
Once daily as 1 drop (topical application) in the evening
|
|---|---|
|
Percentage of Participants With Progression of Visual Field
|
3.1 Percentage of Participants
|
Adverse Events
Xalatan®
Serious adverse events
| Measure |
Xalatan®
n=902 participants at risk
Once daily as 1 drop (topical application) in the evening
|
|---|---|
|
Cardiac disorders
Myocardial infarction
|
0.11%
1/902
Safety population: all subjects who received at least 1 dose of study medication. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.11%
1/902
Safety population: all subjects who received at least 1 dose of study medication. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
|
|
Infections and infestations
Herpes zoster
|
0.11%
1/902
Safety population: all subjects who received at least 1 dose of study medication. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm
|
0.11%
1/902
Safety population: all subjects who received at least 1 dose of study medication. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.11%
1/902
Safety population: all subjects who received at least 1 dose of study medication. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
|
|
Nervous system disorders
Dementia
|
0.11%
1/902
Safety population: all subjects who received at least 1 dose of study medication. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.11%
1/902
Safety population: all subjects who received at least 1 dose of study medication. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
|
Other adverse events
| Measure |
Xalatan®
n=902 participants at risk
Once daily as 1 drop (topical application) in the evening
|
|---|---|
|
Cardiac disorders
Angina pectoris
|
0.11%
1/902
Safety population: all subjects who received at least 1 dose of study medication. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
|
|
Ear and labyrinth disorders
Vertigo
|
0.11%
1/902
Safety population: all subjects who received at least 1 dose of study medication. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
|
|
Eye disorders
Conjunctival irritation
|
0.22%
2/902
Safety population: all subjects who received at least 1 dose of study medication. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
|
|
Eye disorders
Conjunctivitis
|
0.33%
3/902
Safety population: all subjects who received at least 1 dose of study medication. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
|
|
Eye disorders
Conjunctivitis allergic
|
0.44%
4/902
Safety population: all subjects who received at least 1 dose of study medication. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
|
|
Eye disorders
Diplopia
|
0.11%
1/902
Safety population: all subjects who received at least 1 dose of study medication. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
|
|
Eye disorders
Eye irritation
|
0.11%
1/902
Safety population: all subjects who received at least 1 dose of study medication. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
|
|
Eye disorders
Glaucoma
|
0.11%
1/902
Safety population: all subjects who received at least 1 dose of study medication. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
|
|
General disorders
Ill-defined disorder
|
0.22%
2/902
Safety population: all subjects who received at least 1 dose of study medication. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
|
|
Immune system disorders
Drug hypersensitivity
|
0.22%
2/902
Safety population: all subjects who received at least 1 dose of study medication. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
|
|
Immune system disorders
Hypersensitivity
|
0.22%
2/902
Safety population: all subjects who received at least 1 dose of study medication. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
|
|
Immune system disorders
Seasonal allergy
|
0.11%
1/902
Safety population: all subjects who received at least 1 dose of study medication. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
|
|
Nervous system disorders
Dizziness
|
0.11%
1/902
Safety population: all subjects who received at least 1 dose of study medication. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
|
|
Nervous system disorders
Trigeminal nerve paresis
|
0.11%
1/902
Safety population: all subjects who received at least 1 dose of study medication. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.11%
1/902
Safety population: all subjects who received at least 1 dose of study medication. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.22%
2/902
Safety population: all subjects who received at least 1 dose of study medication. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
|
|
Skin and subcutaneous tissue disorders
Rash macular
|
0.11%
1/902
Safety population: all subjects who received at least 1 dose of study medication. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
|
|
Surgical and medical procedures
Cataract operation
|
0.11%
1/902
Safety population: all subjects who received at least 1 dose of study medication. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
- Publication restrictions are in place
Restriction type: OTHER