XCHANGE: Non-Interventional Study In Patients With Ocular Hypertension And Open Angle Glaucoma Treated With Xalatan And Xalacom

• Sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01012245
• Collaborator: (none)
• Enrollment: 28,812
• Duration (Months): 107

Study Details

Study Description

Brief Summary

Non-interventional study to obtain real life data from the treatment with Xalatan and Xalacom in Germany and to assess the long-term efficacy and tolerability under routine conditions. Data were entered into an electronic case report form.

Condition or Disease	Intervention/Treatment	Phase
Glaucoma; Ocular Hypertension	Other: no intervention

Study Design

• Study Type: Observational
• Actual Enrollment: 28812 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Project "XCHANGE" Non-Interventional Study
• Study Start Date: Jan 1, 2000
• Actual Primary Completion Date: Dec 1, 2008
• Actual Study Completion Date: Dec 1, 2008

Arms and Interventions

Arm	Intervention/Treatment
patients with glaucoma and ocular hypertension	Other: no intervention

Outcome Measures

Primary Outcome Measures

1. Change From Baseline in Intraocular Pressure (IOP) [Baseline, 1 year, 2 years, and 3 years]

   Mean IOP values measured by applanation tonometry. Only Goldman values are displayed; if values were given for both right and left eye, the value of the right eye was analyzed. Change (absolute difference) calculated as mean of (value of IOP at observation minus baseline value). Study course is reported by yearly intervals and clustered as 1 year (12±3 months), 2 years (24±3 months), and 3 years (36±3 months).

2. Aulhorn Stage (Visual Field Defects) [Baseline, 1 year, 2 years, and 3 years]

   Number of subjects at each Aulhorn stage. Staged as: No scotoma; Stage I (relative scotomas only), Stage II (absolute scotomas without connection to the blind spot), Stage III (absolute scotomas with connection to the blind spot), Stage IV (absolute scotomas more than 1 quadrant affected), and Stage V (temporal residual visual field only). If values were given for both right and left eye, the value of the right eye was analyzed.

3. Change From Baseline in Optic Disc Excavation: Vertical Cup to Disc Ratio [Baseline, 1 year, 2 years, and 3 years]

   Mean vertical cup to disc (cup/disc or C/D) ratio to assess the progression of glaucoma; calculated as the ratio of the diameter of the depression (cup) to that of the optical nerve head (disc). If values were given for both right and left eye, the value of the right eye was analyzed. Change calculated as mean of (value of cup/disc ratio at observation minus baseline value).

4. Change From Baseline in Optic Disc Excavation: Horizontal Cup to Disc Ratio [Baseline, 1 year, 2 years, and 3 years]

   Mean horizontal cup to disc (cup/disc or C/D) ratio to assess the progression of glaucoma; calculated as the ratio of the diameter of the depression (cup) to that of the optical nerve head (disc). If values were given for both right and left eye, the value of the right eye was analyzed. Change calculated as mean of (value of cup/disc ratio at observation minus baseline value).

Secondary Outcome Measures

1. Investigator Assessment of Xalatan® Efficacy [Baseline, 1 year, 2 years, and 3 years]

   Number of subjects for Investigator assessment of the efficacy of Xalatan® treatment rated as excellent (highly effective), very good, good, moderate, sufficient, and insufficient (not effective).

2. Subject Assessment of Satisfaction With Xalatan® Treatment [Baseline, 1 year, 2 years, and 3 years]

   Number of subjects for assessment of subject satisfaction with Xalatan® treatment; categorized as excellent (full satisfaction), very good, good, moderate, sufficient, and insufficient (no satisfaction).

3. Visual Acuity (Visus) [Baseline, 1 year, 2 years, and 3 years]

   Number of subjects with visual acuity evaluations: amaurosis (partial or total loss of sight); hand movements (able to detect gross object and motion perception without detailed discrimination); finger count (able to count fingers at a given distance); visual acuity scale: range 0.05 (low acuity) to >1.2 (greater acuity). If values were given for both the right eye and left eye, the value of the right eye was analyzed.

4. Visual Impairment Due to Glaucoma [Baseline, 1 year, 2 years, and 3 years]

   Number of subjects per level of visual impairment categorized as not at all (no impairment), a little bit, moderate, severe, and very severe (very severe impairment).

5. Subject Self-care: Application of Eye Drops [Baseline, 1 year, 2 years, and 3 years]

   Number of subjects per level of ability for application (administration) of eye drops categorized as without the help of nursing staff (apply without help) and with the help of nursing staff (apply with help).

6. Reasons for Changes in Glaucoma Therapy [January 2000 through December 2008]

   Number of subjects for each reason for change of therapy; there may be more than one reason possible per patient. Reasons for changes in glaucoma therapy was reported from January 2000 through December 2008 independent of the duration of any individual subject's time on study.

7. Investigator Assessment of Tolerability of Xalatan® Treatment [Baseline up to 3 years]

   Number of subjects for the Investigator's assessment of subjects tolerability of Xalatan® treatment categorized as excellent, very good, good, moderate, sufficient, or insufficient. The occurrence of adverse events (a side effect that may not have any causal relationship to study treatment) was documented as tolerability data.

8. Reasons for Discontinuation From Study [January 2000 through December 2008]

   Number of subjects per reason for discontinuation from the study. More than one reason for discontinuation is possible per patient. Discontinuation analysis was performed independent of the duration of any individual subject's time on study.

9. Changes to the Color of the Iris During Xalatan® or Xalacom® Treatment [Baseline up to 3 years]

   Number of subjects with documented change to the color of the iris during treatment with Xalatan® or Xalacom®.

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• patients with ocular hypertension or glaucoma, defined by SmPC

Exclusion Criteria:

• defined by SmPC

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

Investigators

• Study Director: Pfizer CT.gov Call Center, Pfizer

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• To obtain contact information for a study center near you, click here.

Publications

None provided.

• Responsible Party: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
• ClinicalTrials.gov Identifier: NCT01012245
• Other Study ID Numbers: 912-OPT-0091-131; A6111100, 912-OPT-0091-131
• First Posted: Nov 13, 2009
• Last Update Posted: Feb 25, 2021
• Last Verified: Feb 1, 2010

• Keywords provided by Pfizer's Upjohn has merged with Mylan to form Viatris Inc.: Xchange; Xalatan; Xalacom; Betablocker; observational; longterm
• Additional relevant MeSH terms: Glaucoma; Ocular Hypertension; Hypertension

Study Results

Participant Flow

Recruitment Details	Open-label, prospective, multi-center, non-interventional cohort study (NIS) at 385 centers (office-based ophthalmologists); number of subjects per center was not limited.
Pre-assignment Detail	Subjects were assigned to a therapeutic strategy within current practice and not according to a protocol.

Arm/Group Title	Subjects With Glaucoma and Ocular Hypertension
Arm/Group Description	All subjects group: documented diagnosis of glaucoma or ocular hypertension at baseline visit; includes subjects from the 4 treatment groups: Xalatan®: subjects with Xalatan® (latanoprost) monotherapy at baseline visit; Betablockers: subjects with only 1 betablocker and subjects with more than one betablocker at baseline visit; Xalacom®: subjects with Xalacom® (latanoprost + timolol maleate) therapy at baseline visit; other medications: subjects with other or no hypotensive therapy at baseline visit.
Period Title: Overall Study
STARTED	28812
COMPLETED	26385
NOT COMPLETED	2427

Baseline Characteristics

Arm/Group Title	Xalatan®	Betablockers	Xalacom®	Other Medication	Total
Arm/Group Description	Subjects with Xalatan® (latanoprost) monotherapy at baseline visit	Subjects with only 1 betablocker and subjects with more than one betablocker at baseline visit	Subjects with Xalacom® (latanoprost + timolol maleate) therapy at baseline visit	Subjects with other or no hypotensive therapy at baseline visit	Total of all reporting groups
Overall Participants	13486	1884	746	12696	28812
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	64.9 (13.4)	65.3 (12.7)	66.5 (12.7)	66.9 (13.3)	65.9 (13.3)
Sex: Female, Male (Count of Participants)
Female	7636 56.6%	1101 58.4%	383 51.3%	7493 59%	16613 57.7%
Male	5850 43.4%	783 41.6%	363 48.7%	5203 41%	12199 42.3%
Concomitant ocular diseases at baseline (participants) [Number]
Concomitant ocular disease (right eye [OD])	13137 97.4%	1846 98%	731 98%	12328 97.1%	28042 97.3%
Concomitant ocular disease (left eye [OS])	13179 97.7%	1847 98%	732 98.1%	12350 97.3%	28108 97.6%
No concomitant diseases OD	6737 50%	1060 56.3%	315 42.2%	4742 37.4%	12854 44.6%
No concomitant diseases OS	6730 49.9%	1067 56.6%	308 41.3%	4757 37.5%	12862 44.6%
At least 1 concomitant disease OD	5426 40.2%	786 41.7%	416 55.8%	6488 51.1%	13116 45.5%
At least 1 concomitant disease OS	5460 40.5%	780 41.4%	424 56.8%	6492 51.1%	13156 45.7%
Status post cataract surgery OD	309 2.3%	39 2.1%	21 2.8%	731 5.8%	1100 3.8%
Status post cataract surgery OS	338 2.5%	40 2.1%	19 2.5%	752 5.9%	1149 4%
Status post glaucoma surgery OD	1276 9.5%	189 10%	109 14.6%	1799 14.2%	3373 11.7%
Status post glaucoma surgery OS	1292 9.6%	184 9.8%	107 14.3%	1729 13.6%	3312 11.5%
Status post laser surgery for glaucoma OD	656 4.9%	56 3%	54 7.2%	1070 8.4%	1836 6.4%
Status post laser surgery for glaucoma OS	637 4.7%	56 3%	64 8.6%	1061 8.4%	1818 6.3%
Cataract OD	2297 17%	370 19.6%	209 28%	2542 20%	5418 18.8%
Cataract OS	2302 17.1%	370 19.6%	220 29.5%	2587 20.4%	5479 19%
Other disease OD	2249 16.7%	280 14.9%	147 19.7%	2639 20.8%	5315 18.4%
Other disease OS	2269 16.8%	285 15.1%	143 19.2%	2633 20.7%	5330 18.5%
Missing values OD	974 7.2%	0 0%	0 0%	1098 8.6%	2072 7.2%
Missing values OS	989 7.3%	0 0%	0 0%	1101 8.7%	2090 7.3%
Concomitant systemic diseases at baseline (participants) [Number]
No concomitant diseases	6895 51.1%	1045 55.5%	396 53.1%	5734 45.2%	14070 48.8%
At least 1 concomitant disease	5638 41.8%	839 44.5%	350 46.9%	5854 46.1%	12681 44%
Diabetes mellitus	1644 12.2%	247 13.1%	107 14.3%	1743 13.7%	3741 13%
Asthma	532 3.9%	43 2.3%	4 0.5%	484 3.8%	1063 3.7%
Cardiac insufficiency	891 6.6%	136 7.2%	48 6.4%	1118 8.8%	2193 7.6%
Hypotension	347 2.6%	75 4%	24 3.2%	288 2.3%	734 2.5%
Hypertension	2257 16.7%	453 24%	192 25.7%	2288 18%	5190 18%
Other disease	1696 12.6%	200 10.6%	75 10.1%	1902 15%	3873 13.4%
Missing values	953 7.1%	0 0%	0 0%	1108 8.7%	2061 7.2%
Glaucoma diagnosis at baseline (participants) [Number]
Glaucoma chronicum simplex OD	9863 73.1%	1595 84.7%	560 75.1%	9266 73%	21284 73.9%
Glaucoma chronicum simplex OS	9874 73.2%	1590 84.4%	562 75.3%	9269 73%	21295 73.9%
Normal tension glaucoma OD	818 6.1%	51 2.7%	55 7.4%	486 3.8%	1410 4.9%
Normal tension glaucoma OS	834 6.2%	53 2.8%	53 7.1%	507 4%	1447 5%
Chronic narrow-angle glaucoma OD	496 3.7%	43 2.3%	22 2.9%	804 6.3%	1365 4.7%
Chronic narrow-angle glaucoma OS	503 3.7%	43 2.3%	22 2.9%	804 6.3%	1372 4.8%
Congenital glaucoma OD	26 0.2%	7 0.4%	0 0%	58 0.5%	91 0.3%
Congenital glaucoma OS	24 0.2%	8 0.4%	1 0.1%	55 0.4%	88 0.3%
Exfoliation glaucoma OD	339 2.5%	41 2.2%	15 2%	381 3%	776 2.7%
Exfoliation glaucoma OS	335 2.5%	36 1.9%	16 2.1%	390 3.1%	777 2.7%
Pigment dispersion glaucoma OD	135 1%	13 0.7%	8 1.1%	155 1.2%	311 1.1%
Pigment dispersion glaucoma OS	137 1%	13 0.7%	9 1.2%	150 1.2%	309 1.1%
Neovascular glaucoma OD	27 0.2%	3 0.2%	5 0.7%	93 0.7%	128 0.4%
Neovascular glaucoma OS	30 0.2%	6 0.3%	5 0.7%	73 0.6%	114 0.4%
Other secondary glaucoma OD	152 1.1%	14 0.7%	18 2.4%	242 1.9%	426 1.5%
Other secondary glaucoma OS	158 1.2%	10 0.5%	16 2.1%	262 2.1%	446 1.5%
Acute angle closure OD	11 0.1%	3 0.2%	0 0%	11 0.1%	25 0.1%
Acute angle closure OS	10 0.1%	4 0.2%	0 0%	9 0.1%	23 0.1%
Ocular hypertension OD	987 7.3%	60 3.2%	45 6%	467 3.7%	1559 5.4%
Ocular hypertension OS	987 7.3%	63 3.3%	46 6.2%	468 3.7%	1564 5.4%
Other glaucoma OD	283 2.1%	16 0.8%	3 0.4%	365 2.9%	667 2.3%
Other glaucoma OS	287 2.1%	21 1.1%	2 0.3%	363 2.9%	673 2.3%
No glaucoma OD	262 1.9%	38 2%	14 1.9%	267 2.1%	581 2%
No glaucoma OS	230 1.7%	37 2%	13 1.7%	259 2%	539 1.9%
Missing values OD	87 0.6%	0 0%	1 0.1%	101 0.8%	189 0.7%
Missing values OS	77 0.6%	0 0%	1 0.1%	87 0.7%	165 0.6%
Duration of glaucoma disease at baseline (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	5.1 (5.6)	6.0 (5.9)	6.6 (6.1)	6.6 (6.8)	5.9 (6.2)

Outcome Measures

1. Primary Outcome

Title	Change From Baseline in Intraocular Pressure (IOP)
Description	Mean IOP values measured by applanation tonometry. Only Goldman values are displayed; if values were given for both right and left eye, the value of the right eye was analyzed. Change (absolute difference) calculated as mean of (value of IOP at observation minus baseline value). Study course is reported by yearly intervals and clustered as 1 year (12±3 months), 2 years (24±3 months), and 3 years (36±3 months).
Time Frame	Baseline, 1 year, 2 years, and 3 years

Outcome Measure Data

Analysis Population Description

All subjects group and each treatment group population. N=number of participants with IOP data at baseline; (n)=number of participants with analyzable data at observation for All subjects, Xalatan®, Betablockers, Xalacom®, and Other medications, respectively.

Arm/Group Title	All Subjects	Xalatan®	Betablockers	Xalacom®	Other Medications
Arm/Group Description	Documented diagnosis of glaucoma or ocular hypertension at baseline visit; includes subjects from the 4 treatment groups.	Subjects with Xalatan® (latanoprost) monotherapy at baseline visit	Subjects with only 1 betablocker and subjects with more than one betablocker at baseline visit.	Subjects with Xalacom® (latanoprost + timolol maleate) therapy at baseline visit	Subjects with other or no hypotensive therapy at baseline visit.
Measure Participants	20073	8735	1508	494	9336
1 year (n=10886,4134, 357, 209, 3029)	-1.5 (4.4)	-0.7 (3.5)	-1.0 (3.4)	-0.2 (3.5)	-1.1 (4.6)
2 years (n=7558, 2631, 175, 80, 1834)	-1.6 (4.5)	-0.7 (3.6)	-0.8 (3.2)	-0.5 (3.1)	-1.4 (4.6)
3 years (n=5023, 1753, 64, 40, 1115)	-1.6 (4.5)	-0.7 (3.7)	-1.2 (3.1)	-0.3 (3.2)	-1.4 (4.4)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	All Subjects
	Comments	IOP 1 year (n=11602)
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean value
	Estimated Value	17.2
	Confidence Interval	() 95%; 17.2 to 17.3
	Parameter Dispersion	Type: Standard Deviation; Value: 3.4
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Xalatan®
	Comments	IOP 1 year (n=4450)
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean value
	Estimated Value	16.9
	Confidence Interval	() 95%; 16.8 to 17.0
	Parameter Dispersion	Type: Standard Deviation; Value: 2.9
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Betablockers
	Comments	IOP 1 year (n=357)
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean value
	Estimated Value	17.3
	Confidence Interval	() 95%; 17.1 to 17.5
	Parameter Dispersion	Type: Standard Deviation; Value: 2.2
	Estimation Comments

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Xalacom®
	Comments	IOP 1 year (n=220)
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean value
	Estimated Value	16.9
	Confidence Interval	() 95%; 16.4 to 17.3
	Parameter Dispersion	Type: Standard Deviation; Value: 3.2
	Estimation Comments

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	Other Medications
	Comments	IOP 1 year (n=3277)
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean value
	Estimated Value	17.6
	Confidence Interval	() 95%; 17.5 to 17.8
	Parameter Dispersion	Type: Standard Deviation; Value: 4.1
	Estimation Comments

Statistical Analysis 6

Statistical Analysis Overview	Comparison Group Selection	All Subjects
	Comments	IOP 2 years (n=8051)
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean value
	Estimated Value	17.0
	Confidence Interval	() 95%; 17.0 to 17.1
	Parameter Dispersion	Type: Standard Deviation; Value: 3.4
	Estimation Comments

Statistical Analysis 7

Statistical Analysis Overview	Comparison Group Selection	Xalatan®
	Comments	IOP 2 years (n=2808)
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean value
	Estimated Value	16.8
	Confidence Interval	() 95%; 16.7 to 16.9
	Parameter Dispersion	Type: Standard Deviation; Value: 2.9
	Estimation Comments

Statistical Analysis 8

Statistical Analysis Overview	Comparison Group Selection	Betablockers
	Comments	IOP 2 years (n=175)
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean value
	Estimated Value	17.2
	Confidence Interval	() 95%; 17.0 to 17.5
	Parameter Dispersion	Type: Standard Deviation; Value: 1.8
	Estimation Comments

Statistical Analysis 9

Statistical Analysis Overview	Comparison Group Selection	Xalacom®
	Comments	IOP 2 years (n=83)
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean value
	Estimated Value	16.6
	Confidence Interval	() 95%; 15.9 to 17.2
	Parameter Dispersion	Type: Standard Deviation; Value: 2.8
	Estimation Comments

Statistical Analysis 10

Statistical Analysis Overview	Comparison Group Selection	Other Medications
	Comments	IOP 2 years (n=2002)
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean value
	Estimated Value	17.1
	Confidence Interval	() 95%; 16.9 to 17.2
	Parameter Dispersion	Type: Standard Deviation; Value: 3.7
	Estimation Comments

Statistical Analysis 11

Statistical Analysis Overview	Comparison Group Selection	All Subjects
	Comments	IOP 3 years (n=5469)
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean value
	Estimated Value	17.0
	Confidence Interval	() 95%; 16.9 to 17.1
	Parameter Dispersion	Type: Standard Deviation; Value: 3.4
	Estimation Comments

Statistical Analysis 12

Statistical Analysis Overview	Comparison Group Selection	Xalatan®
	Comments	IOP 3 years (n=1932)
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean value
	Estimated Value	16.8
	Confidence Interval	() 95%; 16.7 to 17.0
	Parameter Dispersion	Type: Standard Deviation; Value: 3.2
	Estimation Comments

Statistical Analysis 13

Statistical Analysis Overview	Comparison Group Selection	Betablockers
	Comments	IOP 3 years (n=64)
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean value
	Estimated Value	17.5
	Confidence Interval	() 95%; 16.9 to 18.1
	Parameter Dispersion	Type: Standard Deviation; Value: 2.5
	Estimation Comments

Statistical Analysis 14

Statistical Analysis Overview	Comparison Group Selection	Xalacom®
	Comments	IOP 3 years (n=44)
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean value
	Estimated Value	16.5
	Confidence Interval	() 95%; 15.7 to 17.4
	Parameter Dispersion	Type: Standard Deviation; Value: 2.8
	Estimation Comments

Statistical Analysis 15

Statistical Analysis Overview	Comparison Group Selection	Other Medications
	Comments	IOP 3 years (n=1251)
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean value
	Estimated Value	16.9
	Confidence Interval	() 95%; 16.7 to 17.1
	Parameter Dispersion	Type: Standard Deviation; Value: 3.6
	Estimation Comments

2. Primary Outcome

Title	Aulhorn Stage (Visual Field Defects)
Description	Number of subjects at each Aulhorn stage. Staged as: No scotoma; Stage I (relative scotomas only), Stage II (absolute scotomas without connection to the blind spot), Stage III (absolute scotomas with connection to the blind spot), Stage IV (absolute scotomas more than 1 quadrant affected), and Stage V (temporal residual visual field only). If values were given for both right and left eye, the value of the right eye was analyzed.
Time Frame	Baseline, 1 year, 2 years, and 3 years

Outcome Measure Data

Analysis Population Description

All subjects group and all treatment groups populations

Arm/Group Title	All Subjects	Xalatan®	Betablockers	Xalacom®	Other Medications
Arm/Group Description	Documented diagnosis of glaucoma or ocular hypertension at baseline visit; includes subjects from the 4 treatment groups.	Subjects with Xalatan® (latanoprost) monotherapy at baseline visit	Subjects with only 1 betablocker and subjects with more than one betablocker at baseline visit.	Subjects with Xalacom® (latanoprost + timolol maleate) therapy at baseline visit	Subjects with other or no hypotensive therapy at baseline visit.
Measure Participants	28812	13486	1884	746	12696
Baseline: No scotoma	7753 57.5%	4074 216.2%	493 66.1%	200 1.6%	2986 10.4%
Baseline: Stage I	3759 27.9%	1915 101.6%	254 34%	68 0.5%	1522 5.3%
Baseline: Stage II	1904 14.1%	826 43.8%	119 16%	47 0.4%	912 3.2%
Baseline: Stage III	1313 9.7%	467 24.8%	51 6.8%	57 0.4%	738 2.6%
Baseline: Stage IV	949 7%	268 14.2%	29 3.9%	17 0.1%	635 2.2%
Baseline: Stage V	646 4.8%	210 11.1%	13 1.7%	8 0.1%	415 1.4%
Baseline: missing values	12488 92.6%	5726 303.9%	925 124%	349 2.7%	5488 19%
1 year: No scotoma	4493 33.3%	2068 109.8%	157 21%	94 0.7%	903 3.1%
1 year: Stage I	1763 13.1%	840 44.6%	24 3.2%	23 0.2%	423 1.5%
1 year: Stage II	868 6.4%	326 17.3%	9 1.2%	18 0.1%	279 1%
1 year: Stage III	576 4.3%	180 9.6%	3 0.4%	12 0.1%	259 0.9%
1 year: Stage IV	372 2.8%	83 4.4%	1 0.1%	9 0.1%	204 0.7%
1 year: Stage V	212 1.6%	57 3%	1 0.1%	3 0%	112 0.4%
1 year: missing values	8820 65.4%	3438 182.5%	171 22.9%	168 1.3%	2342 8.1%
2 years: No scotoma	3374 25%	1491 79.1%	121 16.2%	43 0.3%	572 2%
2 years: Stage I	1339 9.9%	583 30.9%	13 1.7%	8 0.1%	287 1%
2 years: Stage II	603 4.5%	193 10.2%	3 0.4%	7 0.1%	190 0.7%
2 years: Stage III	396 2.9%	120 6.4%	0 0%	4 0%	162 0.6%
2 years: Stage IV	241 1.8%	53 2.8%	1 0.1%	0 0%	124 0.4%
2 years: Stage V	141 1%	34 1.8%	2 0.3%	1 0%	61 0.2%
2 years: missing values	6107 45.3%	2181 115.8%	40 5.4%	76 0.6%	1471 5.1%
3 years: No scotoma	2323 17.2%	1017 54%	16 2.1%	21 0.2%	347 1.2%
3 years: Stage I	933 6.9%	416 22.1%	10 1.3%	5 0%	185 0.6%
3 years: Stage II	420 3.1%	132 7%	7 0.9%	2 0%	120 0.4%
3 years: Stage III	288 2.1%	82 4.4%	3 0.4%	1 0%	119 0.4%
3 years: Stage IV	173 1.3%	38 2%	2 0.3%	2 0%	89 0.3%
3 years: Stage V	80 0.6%	17 0.9%	0 0%	0 0%	35 0.1%
3 years: missing values	4283 31.8%	1515 80.4%	26 3.5%	32 0.3%	924 3.2%

3. Primary Outcome

Title	Change From Baseline in Optic Disc Excavation: Vertical Cup to Disc Ratio
Description	Mean vertical cup to disc (cup/disc or C/D) ratio to assess the progression of glaucoma; calculated as the ratio of the diameter of the depression (cup) to that of the optical nerve head (disc). If values were given for both right and left eye, the value of the right eye was analyzed. Change calculated as mean of (value of cup/disc ratio at observation minus baseline value).
Time Frame	Baseline, 1 year, 2 years, and 3 years

Outcome Measure Data

Analysis Population Description

All subjects group and all treatment groups populations. N=number of participants with optic disc excavation data at baseline; (n)=number of participants with analyzable data at observation for All subjects, Xalatan®, Betablockers, Xalacom®, and Other medications, respectively.

Arm/Group Title	All Subjects	Xalatan®	Betablockers	Xalacom®	Other Medications
Arm/Group Description	Documented diagnosis of glaucoma or ocular hypertension at baseline visit; includes subjects from the 4 treatment groups.	Subjects with Xalatan® (latanoprost) monotherapy at baseline visit	Subjects with only 1 betablocker and subjects with more than one betablocker at baseline visit.	Subjects with Xalacom® (latanoprost + timolol maleate) therapy at baseline visit	Subjects with other or no hypotensive therapy at baseline visit.
Measure Participants	20375	9521	1276	497	9081
1 year (n=11190, 4638, 72, 236, 2714)	0.00 (0.07)	0.00 (0.07)	0.02 (0.08)	0.01 (0.07)	0.00 (0.08)
2 years (n=8088, 3128, 26, 93, 1756)	0.01 (0.08)	0.01 (0.08)	0.00 (0.09)	0.02 (0.07)	0.01 (0.08)
3 years (n=5784, 2173, 16, 34, 1170)	0.01 (0.09)	0.01 (0.08)	0.03 (0.09)	0.02 (0.11)	0.01 (0.10)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	All Subjects
	Comments	Vertical C/D ratio 1 year (n=11966)
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean value
	Estimated Value	0.46
	Confidence Interval	() 95%; 0.46 to 0.47
	Parameter Dispersion	Type: Standard Deviation; Value: 0.25
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Xalatan®
	Comments	Vertical C/D ratio 1 year (n=4944)
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean value
	Estimated Value	0.44
	Confidence Interval	() 95%; 0.43 to 0.44
	Parameter Dispersion	Type: Standard Deviation; Value: 0.24
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Betablockers
	Comments	Vertical C/D ratio 1 year (n=88)
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean value
	Estimated Value	0.39
	Confidence Interval	() 95%; 0.35 to 0.43
	Parameter Dispersion	Type: Standard Deviation; Value: 0.19
	Estimation Comments

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Xalacom®
	Comments	Vertical C/D ratio 1 year (n=241)
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean value
	Estimated Value	0.50
	Confidence Interval	() 95%; 0.47 to 0.53
	Parameter Dispersion	Type: Standard Deviation; Value: 0.24
	Estimation Comments

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	Other Medications
	Comments	Vertical C/D ratio 1 year (n=2949)
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean value
	Estimated Value	0.51
	Confidence Interval	() 95%; 0.50 to 0.52
	Parameter Dispersion	Type: Standard Deviation; Value: 0.27
	Estimation Comments

Statistical Analysis 6

Statistical Analysis Overview	Comparison Group Selection	All Subjects
	Comments	Vertical C/D ratio 2 years (n=8783)
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean value
	Estimated Value	0.46
	Confidence Interval	() 95%; 0.46 to 0.47
	Parameter Dispersion	Type: Standard Deviation; Value: 0.25
	Estimation Comments

Statistical Analysis 7

Statistical Analysis Overview	Comparison Group Selection	Xalatan®
	Comments	Vertical C/D ratio 2 years (n=3396)
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean value
	Estimated Value	0.43
	Confidence Interval	() 95%; 0.42 to 0.44
	Parameter Dispersion	Type: Standard Deviation; Value: 0.23
	Estimation Comments

Statistical Analysis 8

Statistical Analysis Overview	Comparison Group Selection	Betablockers
	Comments	Vertical C/D ratio 2 years (n=31)
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean value
	Estimated Value	0.39
	Confidence Interval	() 95%; 0.33 to 0.45
	Parameter Dispersion	Type: Standard Deviation; Value: 0.16
	Estimation Comments

Statistical Analysis 9

Statistical Analysis Overview	Comparison Group Selection	Xalacom®
	Comments	Vertical C/D ratio 2 years (n=95)
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean value
	Estimated Value	0.49
	Confidence Interval	() 95%; 0.44 to 0.54
	Parameter Dispersion	Type: Standard Deviation; Value: 0.24
	Estimation Comments

Statistical Analysis 10

Statistical Analysis Overview	Comparison Group Selection	Other Medications
	Comments	Vertical C/D ratio 2 years (n=1934)
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean value
	Estimated Value	0.51
	Confidence Interval	() 95%; 0.50 to 0.53
	Parameter Dispersion	Type: Standard Deviation; Value: 0.27
	Estimation Comments

Statistical Analysis 11

Statistical Analysis Overview	Comparison Group Selection	All Subjects
	Comments	Vertical C/D ratio 3 years (n=6344)
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean value
	Estimated Value	0.45
	Confidence Interval	() 95%; 0.44 to 0.45
	Parameter Dispersion	Type: Standard Deviation; Value: 0.24
	Estimation Comments

Statistical Analysis 12

Statistical Analysis Overview	Comparison Group Selection	Xalatan®
	Comments	Vertical C/D ratio 3 years (n=2372)
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean value
	Estimated Value	0.42
	Confidence Interval	() 95%; 0.41 to 0.43
	Parameter Dispersion	Type: Standard Deviation; Value: 0.22
	Estimation Comments

Statistical Analysis 13

Statistical Analysis Overview	Comparison Group Selection	Betablockers
	Comments	Vertical C/D ratio 3 years (n=25)
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean value
	Estimated Value	0.33
	Confidence Interval	() 95%; 0.27 to 0.39
	Parameter Dispersion	Type: Standard Deviation; Value: 0.14
	Estimation Comments

Statistical Analysis 14

Statistical Analysis Overview	Comparison Group Selection	Xalacom®
	Comments	Vertical C/D ratio 3 years (n=36)
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean value
	Estimated Value	0.47
	Confidence Interval	() 95%; 0.41 to 0.53
	Parameter Dispersion	Type: Standard Deviation; Value: 0.18
	Estimation Comments

Statistical Analysis 15

Statistical Analysis Overview	Comparison Group Selection	Other Medications
	Comments	Vertical C/D ratio 3 years (n=1283)
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean value
	Estimated Value	0.49
	Confidence Interval	() 95%; 0.48 to 0.51
	Parameter Dispersion	Type: Standard Deviation; Value: 0.26
	Estimation Comments

4. Primary Outcome

Title	Change From Baseline in Optic Disc Excavation: Horizontal Cup to Disc Ratio
Description	Mean horizontal cup to disc (cup/disc or C/D) ratio to assess the progression of glaucoma; calculated as the ratio of the diameter of the depression (cup) to that of the optical nerve head (disc). If values were given for both right and left eye, the value of the right eye was analyzed. Change calculated as mean of (value of cup/disc ratio at observation minus baseline value).
Time Frame	Baseline, 1 year, 2 years, and 3 years

Outcome Measure Data

Analysis Population Description

All subjects group and all treatment groups populations. N=number of subjects with optic disc excavation data at baseline; (n)=number of subjects with analyzable data at observation for All subjects, Xalatan®, Betablockers, Xalacom®, and Other medications, respectively.

Arm/Group Title	All Subjects	Xalatan®	Betablockers	Xalacom®	Other Medications
Arm/Group Description	Documented diagnosis of glaucoma or ocular hypertension at baseline visit; includes subjects from the 4 treatment groups.	Subjects with Xalatan® (latanoprost) monotherapy at baseline visit	Subjects with only 1 betablocker and subjects with more than one betablocker at baseline visit.	Subjects with Xalacom® (latanoprost + timolol maleate) therapy at baseline visit	Subjects with other or no hypotensive therapy at baseline visit.
Measure Participants	19316	9203	1226	469	8418
1 year (n=10602, 4496, 71, 227, 2442)	0.00 (0.07)	0.00 (0.06)	0.02 (0.08)	0.01 (0.07)	0.00 (0.08)
2 years (n=7727, 3003, 26, 88, 1630)	0.00 (0.08)	0.00 (0.07)	0.00 (0.10)	0.01 (0.06)	0.01 (0.09)
3 years (n=5500, 2089, 16, 33, 1067)	0.01 (0.09)	0.01 (0.07)	0.01 (0.08)	0.02 (0.11)	0.01 (0.10)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	All Subjects
	Comments	Horizontal C/D ratio 1 year (n=11433)
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean value
	Estimated Value	0.45
	Confidence Interval	() 95%; 0.45 to 0.46
	Parameter Dispersion	Type: Standard Deviation; Value: 0.25
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Xalatan®
	Comments	Horizontal C/D ratio 1 year (n=4810)
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean value
	Estimated Value	0.42
	Confidence Interval	() 95%; 0.42 to 0.43
	Parameter Dispersion	Type: Standard Deviation; Value: 0.23
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Betablockers
	Comments	Horizontal C/D ratio 1 year (n=87)
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean value
	Estimated Value	0.37
	Confidence Interval	() 95%; 0.33 to 0.42
	Parameter Dispersion	Type: Standard Deviation; Value: 0.19
	Estimation Comments

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Xalacom®
	Comments	Horizontal C/D ratio 1 year (n=232)
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean value
	Estimated Value	0.50
	Confidence Interval	() 95%; 0.47 to 0.53
	Parameter Dispersion	Type: Standard Deviation; Value: 0.25
	Estimation Comments

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	Other Medications
	Comments	Horizontal C/D ratio 1 year (n=2703)
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean value
	Estimated Value	0.51
	Confidence Interval	() 95%; 0.50 to 0.52
	Parameter Dispersion	Type: Standard Deviation; Value: 0.27
	Estimation Comments

Statistical Analysis 6

Statistical Analysis Overview	Comparison Group Selection	All Subjects
	Comments	Horizontal C/D ratio 2 years (n=8427)
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean value
	Estimated Value	0.45
	Confidence Interval	() 95%; 0.44 to 0.45
	Parameter Dispersion	Type: Standard Deviation; Value: 0.25
	Estimation Comments

Statistical Analysis 7

Statistical Analysis Overview	Comparison Group Selection	Xalatan®
	Comments	Horizontal C/D ratio 2 years (n=3276)
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean value
	Estimated Value	0.41
	Confidence Interval	() 95%; 0.40 to 0.42
	Parameter Dispersion	Type: Standard Deviation; Value: 0.23
	Estimation Comments

Statistical Analysis 8

Statistical Analysis Overview	Comparison Group Selection	Betablockers
	Comments	Horizontal C/D ratio 2 years (n=31)
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean value
	Estimated Value	0.38
	Confidence Interval	() 95%; 0.31 to 0.45
	Parameter Dispersion	Type: Standard Deviation; Value: 0.19
	Estimation Comments

Statistical Analysis 9

Statistical Analysis Overview	Comparison Group Selection	Xalacom®
	Comments	Horizontal C/D ratio 2 years (n=92)
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean value
	Estimated Value	0.50
	Confidence Interval	() 95%; 0.45 to 0.56
	Parameter Dispersion	Type: Standard Deviation; Value: 0.25
	Estimation Comments

Statistical Analysis 10

Statistical Analysis Overview	Comparison Group Selection	Other Medications
	Comments	Horizontal C/D ratio 2 years (n=1812)
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean value
	Estimated Value	0.51
	Confidence Interval	() 95%; 0.49 to 0.52
	Parameter Dispersion	Type: Standard Deviation; Value: 0.27
	Estimation Comments

Statistical Analysis 11

Statistical Analysis Overview	Comparison Group Selection	All Subjects
	Comments	Horizontal C/D ratio 3 years (n=6102)
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean value
	Estimated Value	0.43
	Confidence Interval	() 95%; 0.43 to 0.44
	Parameter Dispersion	Type: Standard Deviation; Value: 0.24
	Estimation Comments

Statistical Analysis 12

Statistical Analysis Overview	Comparison Group Selection	Xalatan®
	Comments	Horizontal C/D ratio 3 years (n=2289)
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean value
	Estimated Value	0.40
	Confidence Interval	() 95%; 0.39 to 0.41
	Parameter Dispersion	Type: Standard Deviation; Value: 0.22
	Estimation Comments

Statistical Analysis 13

Statistical Analysis Overview	Comparison Group Selection	Betablockers
	Comments	Horizontal C/D ratio 3 years (n=25)
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean value
	Estimated Value	0.31
	Confidence Interval	() 95%; 0.25 to 0.38
	Parameter Dispersion	Type: Standard Deviation; Value: 0.15
	Estimation Comments

Statistical Analysis 14

Statistical Analysis Overview	Comparison Group Selection	Xalacom®
	Comments	Horizontal C/D ratio 3 years (n=35)
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean value
	Estimated Value	0.49
	Confidence Interval	() 95%; 0.42 to 0.57
	Parameter Dispersion	Type: Standard Deviation; Value: 0.21
	Estimation Comments

Statistical Analysis 15

Statistical Analysis Overview	Comparison Group Selection	Other Medications
	Comments	Horizontal C/D ratio 3 years (n=1204)
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean value
	Estimated Value	0.48
	Confidence Interval	() 95%; 0.47 to 0.50
	Parameter Dispersion	Type: Standard Deviation; Value: 0.26
	Estimation Comments

5. Secondary Outcome

Title	Investigator Assessment of Xalatan® Efficacy
Description	Number of subjects for Investigator assessment of the efficacy of Xalatan® treatment rated as excellent (highly effective), very good, good, moderate, sufficient, and insufficient (not effective).
Time Frame	Baseline, 1 year, 2 years, and 3 years

Outcome Measure Data

Analysis Population Description

Xalatan® treatment group only (subjects with Xalatan® monotherapy at baseline visit).

Arm/Group Title	Xalatan®
Arm/Group Description	Subjects with Xalatan® (latanoprost) monotherapy at baseline visit
Measure Participants	13486
Baseline: Excellent	555 4.1%
Baseline: Very good	978 7.3%
Baseline: Good	538 4%
Baseline: Moderate	92 0.7%
Baseline: Sufficient	15 0.1%
Baseline: Insufficient	23 0.2%
Baseline: missing values	11285 83.7%
1 year: Excellent	910 6.7%
1 year: Very good	3216 23.8%
1 year: Good	2489 18.5%
1 year: Moderate	310 2.3%
1 year: Sufficient	30 0.2%
1 year: Insufficient	34 0.3%
1 year: missing values	3 0%
2 years: Excellent	475 3.5%
2 years: Very good	2153 16%
2 years: Good	1828 13.6%
2 years: Moderate	164 1.2%
2 years: Sufficient	23 0.2%
2 years: Insufficient	10 0.1%
2 years: missing values	2 0%
3 years: Excellent	256 1.9%
3 years: Very good	1548 11.5%
3 years: Good	1307 9.7%
3 years: Moderate	74 0.5%
3 years: Sufficient	19 0.1%
3 years: Insufficient	11 0.1%
3 years: missing values	2 0%

6. Secondary Outcome

Title	Subject Assessment of Satisfaction With Xalatan® Treatment
Description	Number of subjects for assessment of subject satisfaction with Xalatan® treatment; categorized as excellent (full satisfaction), very good, good, moderate, sufficient, and insufficient (no satisfaction).
Time Frame	Baseline, 1 year, 2 years, and 3 years

Outcome Measure Data

Analysis Population Description

Xalatan® treatment group only (subjects with Xalatan monotherapy at baseline visit).

Arm/Group Title	Xalatan®
Arm/Group Description	Subjects with Xalatan® (latanoprost) monotherapy at baseline visit
Measure Participants	13486
Baseline: Excellent	901 6.7%
Baseline: Very good	737 5.5%
Baseline: Good	404 3%
Baseline: Moderate	35 0.3%
Baseline: Sufficient	110 0.8%
Baseline: Insufficient	7 0.1%
Baseline: missing values	11292 83.7%
1 year: Excellent	1078 8%
1 year: Very good	3200 23.7%
1 year: Good	2510 18.6%
1 year: Moderate	169 1.3%
1 year: Sufficient	16 0.1%
1 year: Insufficient	16 0.1%
1 year: missing values	3 0%
2 years: Excellent	621 4.6%
2 years: Very good	2082 15.4%
2 years: Good	1832 13.6%
2 years: Moderate	106 0.8%
2 years: Sufficient	8 0.1%
2 years: Insufficient	4 0%
2 years: missing values	2 0%
3 years: Excellent	343 2.5%
3 years: Very good	1499 11.1%
3 years: Good	1309 9.7%
3 years: Moderate	54 0.4%
3 years: Sufficient	7 0.1%
3 years: Insufficient	3 0%
3 years: missing values	2 0%

7. Secondary Outcome

Title	Visual Acuity (Visus)
Description	Number of subjects with visual acuity evaluations: amaurosis (partial or total loss of sight); hand movements (able to detect gross object and motion perception without detailed discrimination); finger count (able to count fingers at a given distance); visual acuity scale: range 0.05 (low acuity) to >1.2 (greater acuity). If values were given for both the right eye and left eye, the value of the right eye was analyzed.
Time Frame	Baseline, 1 year, 2 years, and 3 years

Outcome Measure Data

Analysis Population Description

All subjects group and all treatment groups populations

Arm/Group Title	All Subjects	Xalatan®	Betablockers	Xalacom®	Other Medications
Arm/Group Description	Documented diagnosis of glaucoma or ocular hypertension at baseline visit; includes subjects from the 4 treatment groups.	Subjects with Xalatan® (latanoprost) monotherapy at baseline visit	Subjects with only 1 betablocker and subjects with more than one betablocker at baseline visit.	Subjects with Xalacom® (latanoprost + timolol maleate) therapy at baseline visit	Subjects with other or no hypotensive therapy at baseline visit.
Measure Participants	28812	13486	1884	746	12696
Baseline: Amaurosis	16 0.1%	4 0.2%	1 0.1%	1 0%	10 0%
Baseline: Hand movements	503 3.7%	176 9.3%	28 3.8%	15 0.1%	284 1%
Baseline: Finger count	241 1.8%	94 5%	15 2%	9 0.1%	123 0.4%
Baseline: 0.05	766 5.7%	238 12.6%	17 2.3%	26 0.2%	485 1.7%
Baseline: 0.1	553 4.1%	194 10.3%	25 3.4%	11 0.1%	323 1.1%
Baseline: 0.2	759 5.6%	308 16.3%	40 5.4%	12 0.1%	399 1.4%
Baseline: 0.3	902 6.7%	355 18.8%	50 6.7%	27 0.2%	470 1.6%
Baseline: 0.4	1345 10%	567 30.1%	62 8.3%	33 0.3%	683 2.4%
Baseline: 0.5	2173 16.1%	941 49.9%	138 18.5%	56 0.4%	1038 3.6%
Baseline: 0.6	2780 20.6%	1242 65.9%	217 29.1%	84 0.7%	1237 4.3%
Baseline: 0.7	1799 13.3%	846 44.9%	107 14.3%	41 0.3%	805 2.8%
Baseline: 0.8	4984 37%	2329 123.6%	395 52.9%	132 1%	2128 7.4%
Baseline: 0.9	1880 13.9%	928 49.3%	130 17.4%	50 0.4%	772 2.7%
Baseline: 1.0	8685 64.4%	4505 239.1%	613 82.2%	222 1.7%	3345 11.6%
Baseline: 1.1	62 0.5%	42 2.2%	8 1.1%	1 0%	11 0%
Baseline: 1.2	513 3.8%	258 13.7%	23 3.1%	13 0.1%	219 0.8%
Baseline: >1.2	117 0.9%	77 4.1%	1 0.1%	5 0%	34 0.1%
Baseline: Missing values	734 5.4%	382 20.3%	14 1.9%	8 0.1%	330 1.1%
1 year: Amaurosis	9 0.1%	0 0%	0 0%	1 0%	4 0%
1 year: Hand movements	319 2.4%	97 5.1%	1 0.1%	5 0%	153 0.5%
1 year: Finger counts	179 1.3%	51 2.7%	5 0.7%	6 0%	79 0.3%
1 year: 0.05	291 2.2%	86 4.6%	2 0.3%	9 0.1%	120 0.4%
1 year: 0.1	238 1.8%	74 3.9%	3 0.4%	7 0.1%	79 0.3%
1 year: 0.2	381 2.8%	127 6.7%	9 1.2%	4 0%	146 0.5%
1 year: 0.3	484 3.6%	160 8.5%	9 1.2%	7 0.1%	180 0.6%
1 year: 0.4	720 5.3%	270 14.3%	7 0.9%	13 0.1%	233 0.8%
1 year: 0.5	1225 9.1%	463 24.6%	19 2.5%	23 0.2%	334 1.2%
1 year: 0.6	1663 12.3%	625 33.2%	68 9.1%	38 0.3%	494 1.7%
1 year: 0.7	1087 8.1%	418 22.2%	1 0.1%	23 0.2%	301 1%
1 year: 0.8	2872 21.3%	1161 61.6%	116 15.5%	57 0.4%	697 2.4%
1 year: 0.9	1152 8.5%	489 26%	5 0.7%	26 0.2%	224 0.8%
1 year: 1.0	4687 34.8%	2242 119%	106 14.2%	78 0.6%	844 2.9%
1 year: 1.1	39 0.3%	28 1.5%	0 0%	0 0%	4 0%
1 year: 1.2	322 2.4%	152 8.1%	0 0%	5 0%	70 0.2%
1 year: >1.2	52 0.4%	28 1.5%	1 0.1%	2 0%	5 0%
1 year: Missing values	1384 10.3%	521 27.7%	14 1.9%	23 0.2%	555 1.9%
2 years: Amaurosis	9 0.1%	1 0.1%	0 0%	1 0%	0 0%
2 years: Hand movements	214 1.6%	53 2.8%	0 0%	2 0%	87 0.3%
2 years: Finger counts	126 0.9%	31 1.6%	4 0.5%	1 0%	49 0.2%
2 years: 0.05	191 1.4%	41 2.2%	0 0%	4 0%	80 0.3%
2 years: 0.1	188 1.4%	52 2.8%	0 0%	3 0%	71 0.2%
2 years: 0.2	263 2%	72 3.8%	4 0.5%	2 0%	90 0.3%
2 years: 0.3	351 2.6%	111 5.9%	0 0%	3 0%	108 0.4%
2 years: 0.4	470 3.5%	150 8%	3 0.4%	6 0%	145 0.5%
2 years: 0.5	856 6.3%	309 16.4%	5 0.7%	14 0.1%	210 0.7%
2 years: 0.6	1167 8.7%	385 20.4%	41 5.5%	16 0.1%	327 1.1%
2 years: 0.7	738 5.5%	255 13.5%	2 0.3%	5 0%	162 0.6%
2 years: 0.8	2051 15.2%	775 41.1%	63 8.4%	28 0.2%	424 1.5%
2 years: 0.9	900 6.7%	352 18.7%	4 0.5%	9 0.1%	160 0.6%
2 years 1.0	3437 25.5%	1607 85.3%	50 6.7%	33 0.3%	536 1.9%
2 years: 1.1	29 0.2%	22 1.2%	0 0%	0 0%	1 0%
2 years: 1.2	234 1.7%	97 5.1%	0 0%	4 0%	41 0.1%
2 years: >1.2	22 0.2%	7 0.4%	0 0%	1 0%	3 0%
2 years: Missing values	955 7.1%	335 17.8%	4 0.5%	7 0.1%	373 1.3%
3 years: Amaurosis	4 0%	1 0.1%	0 0%	0 0%	2 0%
3 years: Hand movements	133 1%	33 1.8%	2 0.3%	0 0%	47 0.2%
3 years: Finger counts	82 0.6%	26 1.4%	0 0%	0 0%	26 0.1%
3 years: 0.05	134 1%	26 1.4%	0 0%	2 0%	57 0.2%
3 years: 0.1	137 1%	34 1.8%	3 0.4%	3 0%	43 0.1%
3 years: 0.2	194 1.4%	53 2.8%	1 0.1%	1 0%	61 0.2%
3 years: 0.3	227 1.7%	65 3.5%	4 0.5%	0 0%	74 0.3%
3 years: 0.4	342 2.5%	107 5.7%	3 0.4%	5 0%	89 0.3%
3 years: 0.5	606 4.5%	207 11%	8 1.1%	5 0%	136 0.5%
3 years: 0.6	789 5.9%	258 13.7%	7 0.9%	9 0.1%	190 0.7%
3 years: 0.7	534 4%	185 9.8%	3 0.4%	1 0%	111 0.4%
3 years: 0.8	1369 10.2%	538 28.6%	16 2.1%	19 0.1%	260 0.9%
3 years: 0.9	593 4.4%	210 11.1%	1 0.1%	3 0%	85 0.3%
3 years: 1.0	2487 18.4%	1147 60.9%	16 2.1%	13 0.1%	347 1.2%
3 years: 1.1	24 0.2%	18 1%	0 0%	0 0%	1 0%
3 years: 1.2	170 1.3%	61 3.2%	0 0%	1 0%	32 0.1%
3 years: >1.2	13 0.1%	5 0.3%	0 0%	1 0%	0 0%
3 years: Missing values	662 4.9%	243 12.9%	0 0%	0 0%	258 0.9%

8. Secondary Outcome

Title	Visual Impairment Due to Glaucoma
Description	Number of subjects per level of visual impairment categorized as not at all (no impairment), a little bit, moderate, severe, and very severe (very severe impairment).
Time Frame	Baseline, 1 year, 2 years, and 3 years

Outcome Measure Data

Analysis Population Description

All subjects group; not summarized by subgroups

Arm/Group Title	All Subjects
Arm/Group Description	Documented diagnosis of glaucoma or ocular hypertension and a documented glaucoma medication at baseline visit.
Measure Participants	28812
Baseline: Not at all	9368 69.5%
Baseline: A little bit	5171 38.3%
Baseline: Moderate	1723 12.8%
Baseline: Severe	627 4.6%
Baseline: Very severe	235 1.7%
Baseline: Missing values	11688 86.7%
1 year: Not at all	7184 53.3%
1 year: A little bit	4269 31.7%
1 year: Moderate	836 6.2%
1 year: Severe	284 2.1%
1 year: Very severe	91 0.7%
1 year: Missing values	4440 32.9%
2 years: Not at all	4917 36.5%
2 years: A little bit	2961 22%
2 years: Moderate	715 5.3%
2 years: Severe	156 1.2%
2 years: Very severe	50 0.4%
2 years: Missing values	3402 25.2%
3 years: Not at all	3120 23.1%
3 years: A little bit	2137 15.8%
3 years: Moderate	501 3.7%
3 years: Severe	110 0.8%
3 years: Very severe	48 0.4%
3 years: Missing values	2584 19.2%

9. Secondary Outcome

Title	Subject Self-care: Application of Eye Drops
Description	Number of subjects per level of ability for application (administration) of eye drops categorized as without the help of nursing staff (apply without help) and with the help of nursing staff (apply with help).
Time Frame	Baseline, 1 year, 2 years, and 3 years

Outcome Measure Data

Analysis Population Description

All subjects group; not summarized by subgroups

Arm/Group Title	All Subjects
Arm/Group Description	Documented diagnosis of glaucoma or ocular hypertension and a documented glaucoma medication at baseline visit.
Measure Participants	28812
Baseline: apply without help	16520 122.5%
Baseline: apply with help	1142 8.5%
Baseline: missing values	11150 82.7%
1 year: apply without help	12415 92.1%
1 year: apply with help	919 6.8%
1 year: missing values	3770 28%
2 years: apply without help	8657 64.2%
2 years: apply with help	391 2.9%
2 years: missing values	3153 23.4%
3 years: apply without help	5829 43.2%
3 years: apply with help	265 2%
3 years: missing values	2406 17.8%

10. Secondary Outcome

Title	Reasons for Changes in Glaucoma Therapy
Description	Number of subjects for each reason for change of therapy; there may be more than one reason possible per patient. Reasons for changes in glaucoma therapy was reported from January 2000 through December 2008 independent of the duration of any individual subject's time on study.
Time Frame	January 2000 through December 2008

Outcome Measure Data

Analysis Population Description

Subjects from the all subjects group that changed therapy through the duration of the study; subjects who changed from or changed to "other" therapy (Other Medication) were not included in this analysis; not summarized by subgroups.

Arm/Group Title	All Subjects
Arm/Group Description	Documented diagnosis of glaucoma or ocular hypertension and a documented glaucoma medication at baseline visit.
Measure Participants	8895
Wish for better compliance	1055 7.8%
Wish for stronger IOP decrease	3474 25.8%
Wish for better local tolerability	787 5.8%
Wish for better systemic tolerability	504 3.7%
No medication until now	490 3.6%
Other reason	284 2.1%
Missing values	3859 28.6%

11. Secondary Outcome

Title	Investigator Assessment of Tolerability of Xalatan® Treatment
Description	Number of subjects for the Investigator's assessment of subjects tolerability of Xalatan® treatment categorized as excellent, very good, good, moderate, sufficient, or insufficient. The occurrence of adverse events (a side effect that may not have any causal relationship to study treatment) was documented as tolerability data.
Time Frame	Baseline up to 3 years

Outcome Measure Data

Analysis Population Description

Xalatan® treatment group only (subjects with Xalatan monotherapy at baseline visit).

Arm/Group Title	Xalatan®
Arm/Group Description	Subjects with Xalatan® (latanoprost) monotherapy at baseline visit
Measure Participants	13486
Baseline: Excellent	619 4.6%
Baseline: Very good	1075 8%
Baseline: Good	449 3.3%
Baseline: Moderate	45 0.3%
Baseline: Sufficient	4 0%
Baseline: Insufficient	9 0.1%
Baseline: Missing values	11285 83.7%
1 year: Excellent	986 7.3%
1 year: Very good	3429 25.4%
1 year: Good	2437 18.1%
1 year: Moderate	110 0.8%
1 year: Sufficient	18 0.1%
1 year: Insufficient	9 0.1%
1 year: Missing values	3 0%
2 years: Excellent	550 4.1%
2 years: Very good	2203 16.3%
2 years: Good	1795 13.3%
2 years: Moderate	96 0.7%
2 years: Sufficient	7 0.1%
2 years: Insufficient	2 0%
2 years: Missing values	2 0%
3 years: Excellent	284 2.1%
3 years: Very good	1571 11.6%
3 years: Good	1281 9.5%
3 years: Moderate	69 0.5%
3 years: Sufficient	8 0.1%
3 years: Insufficient	2 0%
3 years: Missing values	2 0%

12. Secondary Outcome

Title	Reasons for Discontinuation From Study
Description	Number of subjects per reason for discontinuation from the study. More than one reason for discontinuation is possible per patient. Discontinuation analysis was performed independent of the duration of any individual subject's time on study.
Time Frame	January 2000 through December 2008

Outcome Measure Data

Analysis Population Description

Subjects from the All subjects group population who discontinued the study.

Arm/Group Title	All Subjects
Arm/Group Description	Documented diagnosis of glaucoma or ocular hypertension and a documented glaucoma medication at baseline visit.
Measure Participants	2427
Lost to follow-up	717 5.3%
Subject's death	589 4.4%
Subject moved	320 2.4%
Adverse event	337 2.5%
Other reason	302 2.2%

13. Secondary Outcome

Title	Changes to the Color of the Iris During Xalatan® or Xalacom® Treatment
Description	Number of subjects with documented change to the color of the iris during treatment with Xalatan® or Xalacom®.
Time Frame	Baseline up to 3 years

Outcome Measure Data

Analysis Population Description

Xalatan® treatment group (subjects with Xalatan® (latanoprost) monotherapy at baseline visit) and Xalacom® treatment group (latanoprost + timolol maleate) therapy at baseline visit. During the course of the study the data structure (scaling of color) was changed in a way that change in iris color was no longer evaluable; data not summarized.

Arm/Group Title	Xalatan®	Xalacom®
Arm/Group Description	Subjects with Xalatan® (latanoprost) monotherapy at baseline visit	Subjects with Xalacom® (latanoprost + timolol maleate) therapy at baseline visit
Measure Participants	0	0

Adverse Events

Time Frame	Data for Adverse drug reactions was reported January 2000 through December 2008 through the duration of the study independent of the duration of any individual subject's time on study.
Adverse Event Reporting Description	Side effects = Adverse drug reactions: determination by the health-care professional of causal relationship between occurrence of side effect and drug being used; includes ocular and systemic side effects. Reported for All subjects group population.
Arm/Group Title	All Subjects
Arm/Group Description	Subjects with documented diagnosis of glaucoma or ocular hypertension at baseline visit.
All Cause Mortality
	All Subjects
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	All Subjects
	Affected / at Risk (%)	# Events
Total	0/28812 (0%)
Other (Not Including Serious) Adverse Events
	All Subjects
	Affected / at Risk (%)	# Events
Total	6936/28812 (24.1%)
Cardiac disorders
Angina pectoris	1/28812 (0%)
Aortic valve stenosis	1/28812 (0%)
Arrhythmia	220/28812 (0.8%)
Bradycardia	9/28812 (0%)
Cardiac discomfort	1/28812 (0%)
Cardiac failure	1/28812 (0%)
Cardiovascular disorder	9/28812 (0%)
Cyanosis	1/28812 (0%)
Myocardial infarction	1/28812 (0%)
Myocardial ischaemia	1/28812 (0%)
Palpitations	2/28812 (0%)
Tachycardia	1/28812 (0%)
Congenital, familial and genetic disorders
Anophthalmos	6/28812 (0%)
Developmental glaucoma	1/28812 (0%)
Distichiasis	1/28812 (0%)
Ear and labyrinth disorders
Hypoacusis	1/28812 (0%)
Sudden hearing loss	1/28812 (0%)
Tinnitus	3/28812 (0%)
Vertigo	6/28812 (0%)
Endocrine disorders
Goitre	2/28812 (0%)
Eye disorders
Abnormal sensation in eye	12/28812 (0%)
Accommodation disorder	1/28812 (0%)
Acquired corneal dystrophy	1/28812 (0%)
Amblyopia	2/28812 (0%)
Angle closure glaucoma	1/28812 (0%)
Anterior capsule contraction	1/28812 (0%)
Anterior chamber disorder	1/28812 (0%)
Asthenopia	4/28812 (0%)
Astigmatism	1/28812 (0%)
Blepharitis	15/28812 (0.1%)
Cataract	1/28812 (0%)
Chalazion	1/28812 (0%)
Conjunctival haemorrhage	2/28812 (0%)
Conjunctival hyperaemia	4/28812 (0%)
Conjunctival irritation	7/28812 (0%)
Conjunctival oedema	1/28812 (0%)
Conjunctival pigmentation	2/28812 (0%)
Conjunctivitis	4/28812 (0%)
Corneal decompensation	1/28812 (0%)
Corneal defect	1/28812 (0%)
Corneal disorder	1/28812 (0%)
Corneal epithelium defect	3/28812 (0%)
Corneal erosion	4/28812 (0%)
Corneal hypertrophy	1/28812 (0%)
Corneal infiltrates	2/28812 (0%)
Corneal oedema	5/28812 (0%)
Corneal opacity	1/28812 (0%)
Corneal pigmentation	1/28812 (0%)
Corneal thinning	5/28812 (0%)
Cyanopsia	1/28812 (0%)
Dark circles under eyes	2/28812 (0%)
Diplopia	2/28812 (0%)
Dry eye	16/28812 (0.1%)
Ectropion	1/28812 (0%)
Eczema eyelids	5/28812 (0%)
Entropion	1/28812 (0%)
Erythema of eyelid	14/28812 (0%)
Eye discharge	7/28812 (0%)
Eye inflammation	1/28812 (0%)
Eye irritation	2252/28812 (7.8%)
Eye oedema	1/28812 (0%)
Eye pain	17/28812 (0.1%)
Eye pruritus	31/28812 (0.1%)
Eye swelling	1/28812 (0%)
Eyelash discolouration	10/28812 (0%)
Eyelid oedema	7/28812 (0%)
Eyelid ptosis	1/28812 (0%)
Eyelid sensory disorder	2/28812 (0%)
Eyelids pruritus	3/28812 (0%)
Foreign body sensation in eyes	1150/28812 (4%)
Growth of eyelashes	148/28812 (0.5%)
Hypermetropia	1/28812 (0%)
Hyphaema	1/28812 (0%)
Hypoaesthesia eye	2/28812 (0%)
Iris disorder	1/28812 (0%)
Iris hyperpigmentation	21/28812 (0.1%)
Iris hypopigmentation	1/28812 (0%)
Iritis	1/28812 (0%)
Keratitis	4/28812 (0%)
Keratoconjunctivitis sicca	4/28812 (0%)
Lacrimation increased	50/28812 (0.2%)
Macular degeneration	2/28812 (0%)
Macular oedema	9/28812 (0%)
Maculopathy	3/28812 (0%)
Miosis	56/28812 (0.2%)
Mydriasis	1/28812 (0%)
Myodesopsia	2/28812 (0%)
Myopia	1/28812 (0%)
Night blindness	2/28812 (0%)
Ocular hyperaemia	3760/28812 (13.1%)
Optic disc haemorrhage	1/28812 (0%)
Optic nerve cupping	1/28812 (0%)
Photophobia	5/28812 (0%)
Photopsia	3/28812 (0%)
Posterior capsule opacification	1/28812 (0%)
Presbyopia	1/28812 (0%)
Pterygium	1/28812 (0%)
Punctate keratitis	1/28812 (0%)
Pupils unequal	1/28812 (0%)
Retinal haemorrhage	3/28812 (0%)
Retinal vein occlusion	1/28812 (0%)
Retinal vein thrombosis	1/28812 (0%)
Scleral discolouration	1/28812 (0%)
Scotoma	1/28812 (0%)
Sicca syndrome	37/28812 (0.1%)
Strabismus	1/28812 (0%)
Trichiasis	4/28812 (0%)
Vision blurred	17/28812 (0.1%)
Visual impairment	22/28812 (0.1%)
Vitreous haemorrhage	1/28812 (0%)
Vitreous opacities	2/28812 (0%)
Gastrointestinal disorders
Abdominal discomfort	2/28812 (0%)
Abdominal pain upper	1/28812 (0%)
Aphthous stomatitis	1/28812 (0%)
Diarrhoea	1/28812 (0%)
Dry mouth	20/28812 (0.1%)
Dyspepsia	1/28812 (0%)
Gastric disorder	1/28812 (0%)
Nausea	197/28812 (0.7%)
Tongue dry	1/28812 (0%)
General disorders
Adverse drug reaction	14/28812 (0%)
Asthenia	1/28812 (0%)
Chest pain	1/28812 (0%)
Death	3/28812 (0%)
Drug ineffective	4/28812 (0%)
Drug intolerance	5/28812 (0%)
Fatigue	1510/28812 (5.2%)
Mucosal dryness	1/28812 (0%)
Oedema peripheral	1/28812 (0%)
Immune system disorders
Corneal graft rejection	1/28812 (0%)
Drug hypersensitivity	873/28812 (3%)
Multiple allergies	1/28812 (0%)
Reaction to preservatives	1/28812 (0%)
Sarcoidosis	1/28812 (0%)
Seasonal allergy	1/28812 (0%)
Infections and infestations
Adenoviral conjunctivitis	1/28812 (0%)
Bronchitis	2/28812 (0%)
Chronic sinusitis	1/28812 (0%)
Herpes ophthalmic	1/28812 (0%)
Nasopharyngitis	1/28812 (0%)
Injury, poisoning and procedural complications
Corneal scar	1/28812 (0%)
Investigations
Blood pressure decreased	4/28812 (0%)
Blood pressure increased	2/28812 (0%)
Heart rate decreased	1/28812 (0%)
Intraocular pressure decreased	1/28812 (0%)
Intraocular pressure fluctuation	2/28812 (0%)
Thyroid function test normal	1/28812 (0%)
Weight decreased	1/28812 (0%)
Metabolism and nutrition disorders
Diabetes mellitus	3/28812 (0%)
Diabetes mellitus inadequate control	2/28812 (0%)
Gout	1/28812 (0%)
Obesity	1/28812 (0%)
Musculoskeletal and connective tissue disorders
Back pain	3/28812 (0%)
Muscle spasms	1/28812 (0%)
Musculoskeletal pain	1/28812 (0%)
Myalgia	1/28812 (0%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer	1/28812 (0%)
Gastrointestinal carcinoma	1/28812 (0%)
Leukaemia	1/28812 (0%)
Melanocytic naevus	1/28812 (0%)
Nervous system disorders
Balance disorder	1/28812 (0%)
Cerebellar ischaemia	1/28812 (0%)
Cerebrosclerosis	1/28812 (0%)
Cerebrovascular accident	6/28812 (0%)
Dementia	1/28812 (0%)
Dizziness	48/28812 (0.2%)
Dysgeusia	17/28812 (0.1%)
Headache	431/28812 (1.5%)
Memory impairment	1/28812 (0%)
Nervous system disorder	1/28812 (0%)
Paraesthesia	3/28812 (0%)
Parkinsonism	1/28812 (0%)
Senile dementia	1/28812 (0%)
Sensory disturbance	1/28812 (0%)
Trigeminal neuralgia	1/28812 (0%)
Psychiatric disorders
Affect lability	1/28812 (0%)
Anxiety	2/28812 (0%)
Confusional state	2/28812 (0%)
Depressed mood	1/28812 (0%)
Depression	17/28812 (0.1%)
Emotional distress	1/28812 (0%)
Insomnia	1/28812 (0%)
Mental disorder	2/28812 (0%)
Neurosis	2/28812 (0%)
Sleep disorder	8/28812 (0%)
Renal and urinary disorders
Renal disorder	1/28812 (0%)
Renal pain	1/28812 (0%)
Reproductive system and breast disorders
Erectile dysfunction	3/28812 (0%)
Respiratory, thoracic and mediastinal disorders
Asthma	8/28812 (0%)
Bronchitis chronic	3/28812 (0%)
Bronchospasm	204/28812 (0.7%)
Cough	5/28812 (0%)
Dysphonia	1/28812 (0%)
Dyspnoea	20/28812 (0.1%)
Epistaxis	2/28812 (0%)
Increased upper airway secretion	1/28812 (0%)
Nasal congestion	1/28812 (0%)
Nasal dryness	1/28812 (0%)
Oropharyngeal pain	1/28812 (0%)
Rhinorrhoea	1/28812 (0%)
Sneezing	1/28812 (0%)
Throat irritation	3/28812 (0%)
Throat tightness	2/28812 (0%)
Skin and subcutaneous tissue disorders
Alopecia	1/28812 (0%)
Dermatitis	1/28812 (0%)
Dermatitis allergic	6/28812 (0%)
Dry skin	2/28812 (0%)
Hair colour changes	1/28812 (0%)
Hair growth abnormal	2/28812 (0%)
Hyperhidrosis	1/28812 (0%)
Hypertrichosis	10/28812 (0%)
Ingrown hair	1/28812 (0%)
Pruritus generalised	1/28812 (0%)
Psoriasis	1/28812 (0%)
Rash	1/28812 (0%)
Rosacea	1/28812 (0%)
Skin disorder	2/28812 (0%)
Skin hyperpigmentation	9/28812 (0%)
Yellow skin	1/28812 (0%)
Social circumstances
Treatment noncompliance	22/28812 (0.1%)
Surgical and medical procedures
Cardiac pacemaker insertion	3/28812 (0%)
Cataract operation	1/28812 (0%)
Corneal transplant	1/28812 (0%)
Eye excision	1/28812 (0%)
Eye laser surgery	1/28812 (0%)
Eye operation	1/28812 (0%)
Eye prosthesis insertion	3/28812 (0%)
Intraocular lens implant	1/28812 (0%)
Photocoagulation	1/28812 (0%)
Vascular disorders
Angiosclerosis	1/28812 (0%)
Blood pressure inadequately controlled	2/28812 (0%)
Circulatory collapse	2/28812 (0%)
Embolism	1/28812 (0%)
Hypertension	7/28812 (0%)
Hypotension	8/28812 (0%)
Peripheral coldness	2/28812 (0%)
Raynaud's phenomenon	1/28812 (0%)

Limitations/Caveats

Except at baseline, number of subjects analyzed in treatment groups do not necessarily summarize to "All subjects" total; subjects drop out of treatment group when therapy changes. "All subjects" shows all subjects irrespective of any therapy change.

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

Pfizer has the right to review disclosures, requesting a delay of < 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), < 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.