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

Project XCHANGE Non-Interventional Study

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01012245

Acronym

XCHANGE

Enrollment

28812

Registered

2009-11-13

Start date

2000-01-31

Completion date

2008-12-31

Last updated

2021-02-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Glaucoma, Ocular Hypertension

Keywords

Xchange, Xalatan, Xalacom, Betablocker, observational, longterm

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.

Interventions

OTHERno intervention

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Healthy volunteers

Inclusion criteria

* patients with ocular hypertension or glaucoma, defined by SmPC

Exclusion criteria

* defined by SmPC

Design outcomes

Primary

Measure	Time frame	Description
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).
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.
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).
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

Measure	Time frame	Description
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).
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.
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).
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.
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®.
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.
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).
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.
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).

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 details

Subjects were assigned to a therapeutic strategy within current practice and not according to a protocol.

Participants by arm

Arm	Count
Xalatan® Subjects with Xalatan® (latanoprost) monotherapy at baseline visit	13,486
Betablockers Subjects with only 1 betablocker and subjects with more than one betablocker at baseline visit	1,884
Xalacom® Subjects with Xalacom® (latanoprost + timolol maleate) therapy at baseline visit	746
Other Medication Subjects with other or no hypotensive therapy at baseline visit	12,696
Total	28,812

Baseline characteristics

Characteristic	Total	Xalatan®	Betablockers	Xalacom®	Other Medication
Age, Continuous	65.9 years STANDARD_DEVIATION 13.3	64.9 years STANDARD_DEVIATION 13.4	65.3 years STANDARD_DEVIATION 12.7	66.5 years STANDARD_DEVIATION 12.7	66.9 years STANDARD_DEVIATION 13.3
Concomitant ocular diseases at baseline At least 1 concomitant disease OD	13116 participants	5426 participants	786 participants	416 participants	6488 participants
Concomitant ocular diseases at baseline At least 1 concomitant disease OS	13156 participants	5460 participants	780 participants	424 participants	6492 participants
Concomitant ocular diseases at baseline Cataract OD	5418 participants	2297 participants	370 participants	209 participants	2542 participants
Concomitant ocular diseases at baseline Cataract OS	5479 participants	2302 participants	370 participants	220 participants	2587 participants
Concomitant ocular diseases at baseline Concomitant ocular disease (left eye [OS])	28108 participants	13179 participants	1847 participants	732 participants	12350 participants
Concomitant ocular diseases at baseline Concomitant ocular disease (right eye [OD])	28042 participants	13137 participants	1846 participants	731 participants	12328 participants
Concomitant ocular diseases at baseline Missing values OD	2072 participants	974 participants	0 participants	0 participants	1098 participants
Concomitant ocular diseases at baseline Missing values OS	2090 participants	989 participants	0 participants	0 participants	1101 participants
Concomitant ocular diseases at baseline No concomitant diseases OD	12854 participants	6737 participants	1060 participants	315 participants	4742 participants
Concomitant ocular diseases at baseline No concomitant diseases OS	12862 participants	6730 participants	1067 participants	308 participants	4757 participants
Concomitant ocular diseases at baseline Other disease OD	5315 participants	2249 participants	280 participants	147 participants	2639 participants
Concomitant ocular diseases at baseline Other disease OS	5330 participants	2269 participants	285 participants	143 participants	2633 participants
Concomitant ocular diseases at baseline Status post cataract surgery OD	1100 participants	309 participants	39 participants	21 participants	731 participants
Concomitant ocular diseases at baseline Status post cataract surgery OS	1149 participants	338 participants	40 participants	19 participants	752 participants
Concomitant ocular diseases at baseline Status post glaucoma surgery OD	3373 participants	1276 participants	189 participants	109 participants	1799 participants
Concomitant ocular diseases at baseline Status post glaucoma surgery OS	3312 participants	1292 participants	184 participants	107 participants	1729 participants
Concomitant ocular diseases at baseline Status post laser surgery for glaucoma OD	1836 participants	656 participants	56 participants	54 participants	1070 participants
Concomitant ocular diseases at baseline Status post laser surgery for glaucoma OS	1818 participants	637 participants	56 participants	64 participants	1061 participants
Concomitant systemic diseases at baseline Asthma	1063 participants	532 participants	43 participants	4 participants	484 participants
Concomitant systemic diseases at baseline At least 1 concomitant disease	12681 participants	5638 participants	839 participants	350 participants	5854 participants
Concomitant systemic diseases at baseline Cardiac insufficiency	2193 participants	891 participants	136 participants	48 participants	1118 participants
Concomitant systemic diseases at baseline Diabetes mellitus	3741 participants	1644 participants	247 participants	107 participants	1743 participants
Concomitant systemic diseases at baseline Hypertension	5190 participants	2257 participants	453 participants	192 participants	2288 participants
Concomitant systemic diseases at baseline Hypotension	734 participants	347 participants	75 participants	24 participants	288 participants
Concomitant systemic diseases at baseline Missing values	2061 participants	953 participants	0 participants	0 participants	1108 participants
Concomitant systemic diseases at baseline No concomitant diseases	14070 participants	6895 participants	1045 participants	396 participants	5734 participants
Concomitant systemic diseases at baseline Other disease	3873 participants	1696 participants	200 participants	75 participants	1902 participants
Duration of glaucoma disease at baseline	5.9 years STANDARD_DEVIATION 6.2	5.1 years STANDARD_DEVIATION 5.6	6.0 years STANDARD_DEVIATION 5.9	6.6 years STANDARD_DEVIATION 6.1	6.6 years STANDARD_DEVIATION 6.8
Glaucoma diagnosis at baseline Acute angle closure OD	25 participants	11 participants	3 participants	0 participants	11 participants
Glaucoma diagnosis at baseline Acute angle closure OS	23 participants	10 participants	4 participants	0 participants	9 participants
Glaucoma diagnosis at baseline Chronic narrow-angle glaucoma OD	1365 participants	496 participants	43 participants	22 participants	804 participants
Glaucoma diagnosis at baseline Chronic narrow-angle glaucoma OS	1372 participants	503 participants	43 participants	22 participants	804 participants
Glaucoma diagnosis at baseline Congenital glaucoma OD	91 participants	26 participants	7 participants	0 participants	58 participants
Glaucoma diagnosis at baseline Congenital glaucoma OS	88 participants	24 participants	8 participants	1 participants	55 participants
Glaucoma diagnosis at baseline Exfoliation glaucoma OD	776 participants	339 participants	41 participants	15 participants	381 participants
Glaucoma diagnosis at baseline Exfoliation glaucoma OS	777 participants	335 participants	36 participants	16 participants	390 participants
Glaucoma diagnosis at baseline Glaucoma chronicum simplex OD	21284 participants	9863 participants	1595 participants	560 participants	9266 participants
Glaucoma diagnosis at baseline Glaucoma chronicum simplex OS	21295 participants	9874 participants	1590 participants	562 participants	9269 participants
Glaucoma diagnosis at baseline Missing values OD	189 participants	87 participants	0 participants	1 participants	101 participants
Glaucoma diagnosis at baseline Missing values OS	165 participants	77 participants	0 participants	1 participants	87 participants
Glaucoma diagnosis at baseline Neovascular glaucoma OD	128 participants	27 participants	3 participants	5 participants	93 participants
Glaucoma diagnosis at baseline Neovascular glaucoma OS	114 participants	30 participants	6 participants	5 participants	73 participants
Glaucoma diagnosis at baseline No glaucoma OD	581 participants	262 participants	38 participants	14 participants	267 participants
Glaucoma diagnosis at baseline No glaucoma OS	539 participants	230 participants	37 participants	13 participants	259 participants
Glaucoma diagnosis at baseline Normal tension glaucoma OD	1410 participants	818 participants	51 participants	55 participants	486 participants
Glaucoma diagnosis at baseline Normal tension glaucoma OS	1447 participants	834 participants	53 participants	53 participants	507 participants
Glaucoma diagnosis at baseline Ocular hypertension OD	1559 participants	987 participants	60 participants	45 participants	467 participants
Glaucoma diagnosis at baseline Ocular hypertension OS	1564 participants	987 participants	63 participants	46 participants	468 participants
Glaucoma diagnosis at baseline Other glaucoma OD	667 participants	283 participants	16 participants	3 participants	365 participants
Glaucoma diagnosis at baseline Other glaucoma OS	673 participants	287 participants	21 participants	2 participants	363 participants
Glaucoma diagnosis at baseline Other secondary glaucoma OD	426 participants	152 participants	14 participants	18 participants	242 participants
Glaucoma diagnosis at baseline Other secondary glaucoma OS	446 participants	158 participants	10 participants	16 participants	262 participants
Glaucoma diagnosis at baseline Pigment dispersion glaucoma OD	311 participants	135 participants	13 participants	8 participants	155 participants
Glaucoma diagnosis at baseline Pigment dispersion glaucoma OS	309 participants	137 participants	13 participants	9 participants	150 participants
Sex: Female, Male Female	16613 Participants	7636 Participants	1101 Participants	383 Participants	7493 Participants
Sex: Female, Male Male	12199 Participants	5850 Participants	783 Participants	363 Participants	5203 Participants

Adverse events

Event type	EG000 affected / at risk
deaths Total, all-cause mortality	— / —
other Total, other adverse events	6,936 / 28,812
serious Total, serious adverse events	0 / 28,812

Outcome results

Primary

Aulhorn Stage (Visual Field Defects)

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

Population: All subjects group and all treatment groups populations

Arm	Measure	Group	Value (NUMBER)
All Subjects	Aulhorn Stage (Visual Field Defects)	Baseline: Stage IV	949 participants
All Subjects	Aulhorn Stage (Visual Field Defects)	3 years: Stage III	288 participants
All Subjects	Aulhorn Stage (Visual Field Defects)	1 year: Stage II	868 participants
All Subjects	Aulhorn Stage (Visual Field Defects)	1 year: Stage I	1763 participants
All Subjects	Aulhorn Stage (Visual Field Defects)	1 year: No scotoma	4493 participants
All Subjects	Aulhorn Stage (Visual Field Defects)	Baseline: Stage V	646 participants
All Subjects	Aulhorn Stage (Visual Field Defects)	Baseline: missing values	12488 participants
All Subjects	Aulhorn Stage (Visual Field Defects)	Baseline: No scotoma	7753 participants
All Subjects	Aulhorn Stage (Visual Field Defects)	1 year: Stage IV	372 participants
All Subjects	Aulhorn Stage (Visual Field Defects)	3 years: Stage II	420 participants
All Subjects	Aulhorn Stage (Visual Field Defects)	3 years: Stage I	933 participants
All Subjects	Aulhorn Stage (Visual Field Defects)	3 years: No scotoma	2323 participants
All Subjects	Aulhorn Stage (Visual Field Defects)	Baseline: Stage I	3759 participants
All Subjects	Aulhorn Stage (Visual Field Defects)	3 years: missing values	4283 participants
All Subjects	Aulhorn Stage (Visual Field Defects)	2 years: missing values	6107 participants
All Subjects	Aulhorn Stage (Visual Field Defects)	2 years: Stage V	141 participants
All Subjects	Aulhorn Stage (Visual Field Defects)	2 years: Stage IV	241 participants
All Subjects	Aulhorn Stage (Visual Field Defects)	Baseline: Stage II	1904 participants
All Subjects	Aulhorn Stage (Visual Field Defects)	3 years: Stage V	80 participants
All Subjects	Aulhorn Stage (Visual Field Defects)	2 years: Stage III	396 participants
All Subjects	Aulhorn Stage (Visual Field Defects)	2 years: Stage II	603 participants
All Subjects	Aulhorn Stage (Visual Field Defects)	2 years: Stage I	1339 participants
All Subjects	Aulhorn Stage (Visual Field Defects)	Baseline: Stage III	1313 participants
All Subjects	Aulhorn Stage (Visual Field Defects)	3 years: Stage IV	173 participants
All Subjects	Aulhorn Stage (Visual Field Defects)	2 years: No scotoma	3374 participants
All Subjects	Aulhorn Stage (Visual Field Defects)	1 year: missing values	8820 participants
All Subjects	Aulhorn Stage (Visual Field Defects)	1 year: Stage V	212 participants
All Subjects	Aulhorn Stage (Visual Field Defects)	1 year: Stage III	576 participants
Xalatan®	Aulhorn Stage (Visual Field Defects)	Baseline: Stage V	210 participants
Xalatan®	Aulhorn Stage (Visual Field Defects)	1 year: Stage IV	83 participants
Xalatan®	Aulhorn Stage (Visual Field Defects)	Baseline: No scotoma	4074 participants
Xalatan®	Aulhorn Stage (Visual Field Defects)	Baseline: Stage I	1915 participants
Xalatan®	Aulhorn Stage (Visual Field Defects)	Baseline: Stage II	826 participants
Xalatan®	Aulhorn Stage (Visual Field Defects)	Baseline: Stage III	467 participants
Xalatan®	Aulhorn Stage (Visual Field Defects)	Baseline: Stage IV	268 participants
Xalatan®	Aulhorn Stage (Visual Field Defects)	Baseline: missing values	5726 participants
Xalatan®	Aulhorn Stage (Visual Field Defects)	1 year: No scotoma	2068 participants
Xalatan®	Aulhorn Stage (Visual Field Defects)	1 year: Stage I	840 participants
Xalatan®	Aulhorn Stage (Visual Field Defects)	1 year: Stage II	326 participants
Xalatan®	Aulhorn Stage (Visual Field Defects)	1 year: Stage III	180 participants
Xalatan®	Aulhorn Stage (Visual Field Defects)	1 year: Stage V	57 participants
Xalatan®	Aulhorn Stage (Visual Field Defects)	1 year: missing values	3438 participants
Xalatan®	Aulhorn Stage (Visual Field Defects)	2 years: No scotoma	1491 participants
Xalatan®	Aulhorn Stage (Visual Field Defects)	2 years: Stage I	583 participants
Xalatan®	Aulhorn Stage (Visual Field Defects)	2 years: Stage II	193 participants
Xalatan®	Aulhorn Stage (Visual Field Defects)	2 years: Stage III	120 participants
Xalatan®	Aulhorn Stage (Visual Field Defects)	2 years: Stage IV	53 participants
Xalatan®	Aulhorn Stage (Visual Field Defects)	2 years: Stage V	34 participants
Xalatan®	Aulhorn Stage (Visual Field Defects)	2 years: missing values	2181 participants
Xalatan®	Aulhorn Stage (Visual Field Defects)	3 years: No scotoma	1017 participants
Xalatan®	Aulhorn Stage (Visual Field Defects)	3 years: Stage I	416 participants
Xalatan®	Aulhorn Stage (Visual Field Defects)	3 years: Stage II	132 participants
Xalatan®	Aulhorn Stage (Visual Field Defects)	3 years: Stage III	82 participants
Xalatan®	Aulhorn Stage (Visual Field Defects)	3 years: Stage IV	38 participants
Xalatan®	Aulhorn Stage (Visual Field Defects)	3 years: Stage V	17 participants
Xalatan®	Aulhorn Stage (Visual Field Defects)	3 years: missing values	1515 participants
Betablockers	Aulhorn Stage (Visual Field Defects)	Baseline: No scotoma	493 participants
Betablockers	Aulhorn Stage (Visual Field Defects)	Baseline: Stage II	119 participants
Betablockers	Aulhorn Stage (Visual Field Defects)	3 years: Stage I	10 participants
Betablockers	Aulhorn Stage (Visual Field Defects)	2 years: Stage III	0 participants
Betablockers	Aulhorn Stage (Visual Field Defects)	1 year: missing values	171 participants
Betablockers	Aulhorn Stage (Visual Field Defects)	3 years: No scotoma	16 participants
Betablockers	Aulhorn Stage (Visual Field Defects)	2 years: missing values	40 participants
Betablockers	Aulhorn Stage (Visual Field Defects)	1 year: Stage IV	1 participants
Betablockers	Aulhorn Stage (Visual Field Defects)	2 years: Stage IV	1 participants
Betablockers	Aulhorn Stage (Visual Field Defects)	Baseline: Stage IV	29 participants
Betablockers	Aulhorn Stage (Visual Field Defects)	3 years: Stage V	0 participants
Betablockers	Aulhorn Stage (Visual Field Defects)	1 year: No scotoma	157 participants
Betablockers	Aulhorn Stage (Visual Field Defects)	Baseline: Stage III	51 participants
Betablockers	Aulhorn Stage (Visual Field Defects)	2 years: Stage V	2 participants
Betablockers	Aulhorn Stage (Visual Field Defects)	3 years: missing values	26 participants
Betablockers	Aulhorn Stage (Visual Field Defects)	Baseline: Stage I	254 participants
Betablockers	Aulhorn Stage (Visual Field Defects)	2 years: No scotoma	121 participants
Betablockers	Aulhorn Stage (Visual Field Defects)	1 year: Stage V	1 participants
Betablockers	Aulhorn Stage (Visual Field Defects)	Baseline: missing values	925 participants
Betablockers	Aulhorn Stage (Visual Field Defects)	Baseline: Stage V	13 participants
Betablockers	Aulhorn Stage (Visual Field Defects)	3 years: Stage IV	2 participants
Betablockers	Aulhorn Stage (Visual Field Defects)	2 years: Stage I	13 participants
Betablockers	Aulhorn Stage (Visual Field Defects)	1 year: Stage II	9 participants
Betablockers	Aulhorn Stage (Visual Field Defects)	3 years: Stage II	7 participants
Betablockers	Aulhorn Stage (Visual Field Defects)	1 year: Stage I	24 participants
Betablockers	Aulhorn Stage (Visual Field Defects)	1 year: Stage III	3 participants
Betablockers	Aulhorn Stage (Visual Field Defects)	2 years: Stage II	3 participants
Betablockers	Aulhorn Stage (Visual Field Defects)	3 years: Stage III	3 participants
Xalacom®	Aulhorn Stage (Visual Field Defects)	3 years: No scotoma	21 participants
Xalacom®	Aulhorn Stage (Visual Field Defects)	3 years: Stage III	1 participants
Xalacom®	Aulhorn Stage (Visual Field Defects)	Baseline: Stage III	57 participants
Xalacom®	Aulhorn Stage (Visual Field Defects)	1 year: Stage V	3 participants
Xalacom®	Aulhorn Stage (Visual Field Defects)	1 year: Stage IV	9 participants
Xalacom®	Aulhorn Stage (Visual Field Defects)	1 year: missing values	168 participants
Xalacom®	Aulhorn Stage (Visual Field Defects)	2 years: No scotoma	43 participants
Xalacom®	Aulhorn Stage (Visual Field Defects)	2 years: Stage I	8 participants
Xalacom®	Aulhorn Stage (Visual Field Defects)	Baseline: Stage II	47 participants
Xalacom®	Aulhorn Stage (Visual Field Defects)	3 years: Stage IV	2 participants
Xalacom®	Aulhorn Stage (Visual Field Defects)	2 years: Stage II	7 participants
Xalacom®	Aulhorn Stage (Visual Field Defects)	2 years: Stage III	4 participants
Xalacom®	Aulhorn Stage (Visual Field Defects)	2 years: Stage IV	0 participants
Xalacom®	Aulhorn Stage (Visual Field Defects)	Baseline: Stage I	68 participants
Xalacom®	Aulhorn Stage (Visual Field Defects)	3 years: missing values	32 participants
Xalacom®	Aulhorn Stage (Visual Field Defects)	2 years: Stage V	1 participants
Xalacom®	Aulhorn Stage (Visual Field Defects)	2 years: missing values	76 participants
Xalacom®	Aulhorn Stage (Visual Field Defects)	3 years: Stage V	0 participants
Xalacom®	Aulhorn Stage (Visual Field Defects)	1 year: Stage II	18 participants
Xalacom®	Aulhorn Stage (Visual Field Defects)	Baseline: No scotoma	200 participants
Xalacom®	Aulhorn Stage (Visual Field Defects)	3 years: Stage I	5 participants
Xalacom®	Aulhorn Stage (Visual Field Defects)	3 years: Stage II	2 participants
Xalacom®	Aulhorn Stage (Visual Field Defects)	Baseline: Stage V	8 participants
Xalacom®	Aulhorn Stage (Visual Field Defects)	1 year: Stage III	12 participants
Xalacom®	Aulhorn Stage (Visual Field Defects)	Baseline: missing values	349 participants
Xalacom®	Aulhorn Stage (Visual Field Defects)	1 year: No scotoma	94 participants
Xalacom®	Aulhorn Stage (Visual Field Defects)	Baseline: Stage IV	17 participants
Xalacom®	Aulhorn Stage (Visual Field Defects)	1 year: Stage I	23 participants
Other Medications	Aulhorn Stage (Visual Field Defects)	3 years: Stage IV	89 participants
Other Medications	Aulhorn Stage (Visual Field Defects)	Baseline: Stage III	738 participants
Other Medications	Aulhorn Stage (Visual Field Defects)	3 years: Stage I	185 participants
Other Medications	Aulhorn Stage (Visual Field Defects)	2 years: Stage II	190 participants
Other Medications	Aulhorn Stage (Visual Field Defects)	1 year: Stage III	259 participants
Other Medications	Aulhorn Stage (Visual Field Defects)	2 years: Stage I	287 participants
Other Medications	Aulhorn Stage (Visual Field Defects)	3 years: missing values	924 participants
Other Medications	Aulhorn Stage (Visual Field Defects)	Baseline: Stage II	912 participants
Other Medications	Aulhorn Stage (Visual Field Defects)	1 year: Stage V	112 participants
Other Medications	Aulhorn Stage (Visual Field Defects)	Baseline: Stage V	415 participants
Other Medications	Aulhorn Stage (Visual Field Defects)	1 year: Stage II	279 participants
Other Medications	Aulhorn Stage (Visual Field Defects)	3 years: Stage II	120 participants
Other Medications	Aulhorn Stage (Visual Field Defects)	2 years: No scotoma	572 participants
Other Medications	Aulhorn Stage (Visual Field Defects)	1 year: Stage I	423 participants
Other Medications	Aulhorn Stage (Visual Field Defects)	Baseline: missing values	5488 participants
Other Medications	Aulhorn Stage (Visual Field Defects)	Baseline: Stage IV	635 participants
Other Medications	Aulhorn Stage (Visual Field Defects)	2 years: Stage V	61 participants
Other Medications	Aulhorn Stage (Visual Field Defects)	2 years: Stage IV	124 participants
Other Medications	Aulhorn Stage (Visual Field Defects)	Baseline: Stage I	1522 participants
Other Medications	Aulhorn Stage (Visual Field Defects)	1 year: Stage IV	204 participants
Other Medications	Aulhorn Stage (Visual Field Defects)	2 years: missing values	1471 participants
Other Medications	Aulhorn Stage (Visual Field Defects)	Baseline: No scotoma	2986 participants
Other Medications	Aulhorn Stage (Visual Field Defects)	1 year: missing values	2342 participants
Other Medications	Aulhorn Stage (Visual Field Defects)	2 years: Stage III	162 participants
Other Medications	Aulhorn Stage (Visual Field Defects)	3 years: Stage III	119 participants
Other Medications	Aulhorn Stage (Visual Field Defects)	3 years: No scotoma	347 participants
Other Medications	Aulhorn Stage (Visual Field Defects)	1 year: No scotoma	903 participants
Other Medications	Aulhorn Stage (Visual Field Defects)	3 years: Stage V	35 participants

Primary

Change From Baseline in Intraocular Pressure (IOP)

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

Population: 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	Measure	Group	Value (MEAN)	Dispersion
All Subjects	Change From Baseline in Intraocular Pressure (IOP)	1 year (n=10886,4134, 357, 209, 3029)	-1.5 mm Hg	Standard Deviation 4.4
All Subjects	Change From Baseline in Intraocular Pressure (IOP)	3 years (n=5023, 1753, 64, 40, 1115)	-1.6 mm Hg	Standard Deviation 4.5
All Subjects	Change From Baseline in Intraocular Pressure (IOP)	2 years (n=7558, 2631, 175, 80, 1834)	-1.6 mm Hg	Standard Deviation 4.5
Xalatan®	Change From Baseline in Intraocular Pressure (IOP)	2 years (n=7558, 2631, 175, 80, 1834)	-0.7 mm Hg	Standard Deviation 3.6
Xalatan®	Change From Baseline in Intraocular Pressure (IOP)	1 year (n=10886,4134, 357, 209, 3029)	-0.7 mm Hg	Standard Deviation 3.5
Xalatan®	Change From Baseline in Intraocular Pressure (IOP)	3 years (n=5023, 1753, 64, 40, 1115)	-0.7 mm Hg	Standard Deviation 3.7
Betablockers	Change From Baseline in Intraocular Pressure (IOP)	2 years (n=7558, 2631, 175, 80, 1834)	-0.8 mm Hg	Standard Deviation 3.2
Betablockers	Change From Baseline in Intraocular Pressure (IOP)	1 year (n=10886,4134, 357, 209, 3029)	-1.0 mm Hg	Standard Deviation 3.4
Betablockers	Change From Baseline in Intraocular Pressure (IOP)	3 years (n=5023, 1753, 64, 40, 1115)	-1.2 mm Hg	Standard Deviation 3.1
Xalacom®	Change From Baseline in Intraocular Pressure (IOP)	1 year (n=10886,4134, 357, 209, 3029)	-0.2 mm Hg	Standard Deviation 3.5
Xalacom®	Change From Baseline in Intraocular Pressure (IOP)	3 years (n=5023, 1753, 64, 40, 1115)	-0.3 mm Hg	Standard Deviation 3.2
Xalacom®	Change From Baseline in Intraocular Pressure (IOP)	2 years (n=7558, 2631, 175, 80, 1834)	-0.5 mm Hg	Standard Deviation 3.1
Other Medications	Change From Baseline in Intraocular Pressure (IOP)	2 years (n=7558, 2631, 175, 80, 1834)	-1.4 mm Hg	Standard Deviation 4.6
Other Medications	Change From Baseline in Intraocular Pressure (IOP)	1 year (n=10886,4134, 357, 209, 3029)	-1.1 mm Hg	Standard Deviation 4.6
Other Medications	Change From Baseline in Intraocular Pressure (IOP)	3 years (n=5023, 1753, 64, 40, 1115)	-1.4 mm Hg	Standard Deviation 4.4

Comparison: IOP 1 year (n=11602)95% CI: [17.2, 17.3]

Comparison: IOP 1 year (n=4450)95% CI: [16.8, 17]

Comparison: IOP 1 year (n=357)95% CI: [17.1, 17.5]

Comparison: IOP 1 year (n=220)95% CI: [16.4, 17.3]

Comparison: IOP 1 year (n=3277)95% CI: [17.5, 17.8]

Comparison: IOP 2 years (n=8051)95% CI: [17, 17.1]

Comparison: IOP 2 years (n=2808)95% CI: [16.7, 16.9]

Comparison: IOP 2 years (n=175)95% CI: [17, 17.5]

Comparison: IOP 2 years (n=83)95% CI: [15.9, 17.2]

Comparison: IOP 2 years (n=2002)95% CI: [16.9, 17.2]

Comparison: IOP 3 years (n=5469)95% CI: [16.9, 17.1]

Comparison: IOP 3 years (n=1932)95% CI: [16.7, 17]

Comparison: IOP 3 years (n=64)95% CI: [16.9, 18.1]

Comparison: IOP 3 years (n=44)95% CI: [15.7, 17.4]

Comparison: IOP 3 years (n=1251)95% CI: [16.7, 17.1]

Primary

Change From Baseline in Optic Disc Excavation: Horizontal Cup to Disc Ratio

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

Population: 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	Measure	Group	Value (MEAN)	Dispersion
All Subjects	Change From Baseline in Optic Disc Excavation: Horizontal Cup to Disc Ratio	1 year (n=10602, 4496, 71, 227, 2442)	0.00 ratio	Standard Deviation 0.07
All Subjects	Change From Baseline in Optic Disc Excavation: Horizontal Cup to Disc Ratio	3 years (n=5500, 2089, 16, 33, 1067)	0.01 ratio	Standard Deviation 0.09
All Subjects	Change From Baseline in Optic Disc Excavation: Horizontal Cup to Disc Ratio	2 years (n=7727, 3003, 26, 88, 1630)	0.00 ratio	Standard Deviation 0.08
Xalatan®	Change From Baseline in Optic Disc Excavation: Horizontal Cup to Disc Ratio	2 years (n=7727, 3003, 26, 88, 1630)	0.00 ratio	Standard Deviation 0.07
Xalatan®	Change From Baseline in Optic Disc Excavation: Horizontal Cup to Disc Ratio	1 year (n=10602, 4496, 71, 227, 2442)	0.00 ratio	Standard Deviation 0.06
Xalatan®	Change From Baseline in Optic Disc Excavation: Horizontal Cup to Disc Ratio	3 years (n=5500, 2089, 16, 33, 1067)	0.01 ratio	Standard Deviation 0.07
Betablockers	Change From Baseline in Optic Disc Excavation: Horizontal Cup to Disc Ratio	2 years (n=7727, 3003, 26, 88, 1630)	0.00 ratio	Standard Deviation 0.1
Betablockers	Change From Baseline in Optic Disc Excavation: Horizontal Cup to Disc Ratio	1 year (n=10602, 4496, 71, 227, 2442)	0.02 ratio	Standard Deviation 0.08
Betablockers	Change From Baseline in Optic Disc Excavation: Horizontal Cup to Disc Ratio	3 years (n=5500, 2089, 16, 33, 1067)	0.01 ratio	Standard Deviation 0.08
Xalacom®	Change From Baseline in Optic Disc Excavation: Horizontal Cup to Disc Ratio	1 year (n=10602, 4496, 71, 227, 2442)	0.01 ratio	Standard Deviation 0.07
Xalacom®	Change From Baseline in Optic Disc Excavation: Horizontal Cup to Disc Ratio	3 years (n=5500, 2089, 16, 33, 1067)	0.02 ratio	Standard Deviation 0.11
Xalacom®	Change From Baseline in Optic Disc Excavation: Horizontal Cup to Disc Ratio	2 years (n=7727, 3003, 26, 88, 1630)	0.01 ratio	Standard Deviation 0.06
Other Medications	Change From Baseline in Optic Disc Excavation: Horizontal Cup to Disc Ratio	2 years (n=7727, 3003, 26, 88, 1630)	0.01 ratio	Standard Deviation 0.09
Other Medications	Change From Baseline in Optic Disc Excavation: Horizontal Cup to Disc Ratio	1 year (n=10602, 4496, 71, 227, 2442)	0.00 ratio	Standard Deviation 0.08
Other Medications	Change From Baseline in Optic Disc Excavation: Horizontal Cup to Disc Ratio	3 years (n=5500, 2089, 16, 33, 1067)	0.01 ratio	Standard Deviation 0.1

Comparison: Horizontal C/D ratio 1 year (n=11433)95% CI: [0.45, 0.46]

Comparison: Horizontal C/D ratio 1 year (n=4810)95% CI: [0.42, 0.43]

Comparison: Horizontal C/D ratio 1 year (n=87)95% CI: [0.33, 0.42]

Comparison: Horizontal C/D ratio 1 year (n=232)95% CI: [0.47, 0.53]

Comparison: Horizontal C/D ratio 1 year (n=2703)95% CI: [0.5, 0.52]

Comparison: Horizontal C/D ratio 2 years (n=8427)95% CI: [0.44, 0.45]

Comparison: Horizontal C/D ratio 2 years (n=3276)95% CI: [0.4, 0.42]

Comparison: Horizontal C/D ratio 2 years (n=31)95% CI: [0.31, 0.45]

Comparison: Horizontal C/D ratio 2 years (n=92)95% CI: [0.45, 0.56]

Comparison: Horizontal C/D ratio 2 years (n=1812)95% CI: [0.49, 0.52]

Comparison: Horizontal C/D ratio 3 years (n=6102)95% CI: [0.43, 0.44]

Comparison: Horizontal C/D ratio 3 years (n=2289)95% CI: [0.39, 0.41]

Comparison: Horizontal C/D ratio 3 years (n=25)95% CI: [0.25, 0.38]

Comparison: Horizontal C/D ratio 3 years (n=35)95% CI: [0.42, 0.57]

Comparison: Horizontal C/D ratio 3 years (n=1204)95% CI: [0.47, 0.5]

Primary

Change From Baseline in Optic Disc Excavation: Vertical Cup to Disc Ratio

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

Population: 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	Measure	Group	Value (MEAN)	Dispersion
All Subjects	Change From Baseline in Optic Disc Excavation: Vertical Cup to Disc Ratio	1 year (n=11190, 4638, 72, 236, 2714)	0.00 ratio	Standard Deviation 0.07
All Subjects	Change From Baseline in Optic Disc Excavation: Vertical Cup to Disc Ratio	3 years (n=5784, 2173, 16, 34, 1170)	0.01 ratio	Standard Deviation 0.09
All Subjects	Change From Baseline in Optic Disc Excavation: Vertical Cup to Disc Ratio	2 years (n=8088, 3128, 26, 93, 1756)	0.01 ratio	Standard Deviation 0.08
Xalatan®	Change From Baseline in Optic Disc Excavation: Vertical Cup to Disc Ratio	2 years (n=8088, 3128, 26, 93, 1756)	0.01 ratio	Standard Deviation 0.08
Xalatan®	Change From Baseline in Optic Disc Excavation: Vertical Cup to Disc Ratio	1 year (n=11190, 4638, 72, 236, 2714)	0.00 ratio	Standard Deviation 0.07
Xalatan®	Change From Baseline in Optic Disc Excavation: Vertical Cup to Disc Ratio	3 years (n=5784, 2173, 16, 34, 1170)	0.01 ratio	Standard Deviation 0.08
Betablockers	Change From Baseline in Optic Disc Excavation: Vertical Cup to Disc Ratio	2 years (n=8088, 3128, 26, 93, 1756)	0.00 ratio	Standard Deviation 0.09
Betablockers	Change From Baseline in Optic Disc Excavation: Vertical Cup to Disc Ratio	1 year (n=11190, 4638, 72, 236, 2714)	0.02 ratio	Standard Deviation 0.08
Betablockers	Change From Baseline in Optic Disc Excavation: Vertical Cup to Disc Ratio	3 years (n=5784, 2173, 16, 34, 1170)	0.03 ratio	Standard Deviation 0.09
Xalacom®	Change From Baseline in Optic Disc Excavation: Vertical Cup to Disc Ratio	1 year (n=11190, 4638, 72, 236, 2714)	0.01 ratio	Standard Deviation 0.07
Xalacom®	Change From Baseline in Optic Disc Excavation: Vertical Cup to Disc Ratio	3 years (n=5784, 2173, 16, 34, 1170)	0.02 ratio	Standard Deviation 0.11
Xalacom®	Change From Baseline in Optic Disc Excavation: Vertical Cup to Disc Ratio	2 years (n=8088, 3128, 26, 93, 1756)	0.02 ratio	Standard Deviation 0.07
Other Medications	Change From Baseline in Optic Disc Excavation: Vertical Cup to Disc Ratio	2 years (n=8088, 3128, 26, 93, 1756)	0.01 ratio	Standard Deviation 0.08
Other Medications	Change From Baseline in Optic Disc Excavation: Vertical Cup to Disc Ratio	1 year (n=11190, 4638, 72, 236, 2714)	0.00 ratio	Standard Deviation 0.08
Other Medications	Change From Baseline in Optic Disc Excavation: Vertical Cup to Disc Ratio	3 years (n=5784, 2173, 16, 34, 1170)	0.01 ratio	Standard Deviation 0.1

Comparison: Vertical C/D ratio 1 year (n=11966)95% CI: [0.46, 0.47]

Comparison: Vertical C/D ratio 1 year (n=4944)95% CI: [0.43, 0.44]

Comparison: Vertical C/D ratio 1 year (n=88)95% CI: [0.35, 0.43]

Comparison: Vertical C/D ratio 1 year (n=241)95% CI: [0.47, 0.53]

Comparison: Vertical C/D ratio 1 year (n=2949)95% CI: [0.5, 0.52]

Comparison: Vertical C/D ratio 2 years (n=8783)95% CI: [0.46, 0.47]

Comparison: Vertical C/D ratio 2 years (n=3396)95% CI: [0.42, 0.44]

Comparison: Vertical C/D ratio 2 years (n=31)95% CI: [0.33, 0.45]

Comparison: Vertical C/D ratio 2 years (n=95)95% CI: [0.44, 0.54]

Comparison: Vertical C/D ratio 2 years (n=1934)95% CI: [0.5, 0.53]

Comparison: Vertical C/D ratio 3 years (n=6344)95% CI: [0.44, 0.45]

Comparison: Vertical C/D ratio 3 years (n=2372)95% CI: [0.41, 0.43]

Comparison: Vertical C/D ratio 3 years (n=25)95% CI: [0.27, 0.39]

Comparison: Vertical C/D ratio 3 years (n=36)95% CI: [0.41, 0.53]

Comparison: Vertical C/D ratio 3 years (n=1283)95% CI: [0.48, 0.51]

Secondary

Changes to the Color of the Iris During Xalatan® or Xalacom® Treatment

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

Population: 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.

Secondary

Investigator Assessment of Tolerability of Xalatan® Treatment

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

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

Arm	Measure	Group	Value (NUMBER)
All Subjects	Investigator Assessment of Tolerability of Xalatan® Treatment	Baseline: Excellent	619 participants
All Subjects	Investigator Assessment of Tolerability of Xalatan® Treatment	Baseline: Very good	1075 participants
All Subjects	Investigator Assessment of Tolerability of Xalatan® Treatment	Baseline: Good	449 participants
All Subjects	Investigator Assessment of Tolerability of Xalatan® Treatment	Baseline: Moderate	45 participants
All Subjects	Investigator Assessment of Tolerability of Xalatan® Treatment	Baseline: Sufficient	4 participants
All Subjects	Investigator Assessment of Tolerability of Xalatan® Treatment	Baseline: Insufficient	9 participants
All Subjects	Investigator Assessment of Tolerability of Xalatan® Treatment	Baseline: Missing values	11285 participants
All Subjects	Investigator Assessment of Tolerability of Xalatan® Treatment	1 year: Excellent	986 participants
All Subjects	Investigator Assessment of Tolerability of Xalatan® Treatment	1 year: Very good	3429 participants
All Subjects	Investigator Assessment of Tolerability of Xalatan® Treatment	1 year: Good	2437 participants
All Subjects	Investigator Assessment of Tolerability of Xalatan® Treatment	1 year: Moderate	110 participants
All Subjects	Investigator Assessment of Tolerability of Xalatan® Treatment	1 year: Sufficient	18 participants
All Subjects	Investigator Assessment of Tolerability of Xalatan® Treatment	1 year: Insufficient	9 participants
All Subjects	Investigator Assessment of Tolerability of Xalatan® Treatment	1 year: Missing values	3 participants
All Subjects	Investigator Assessment of Tolerability of Xalatan® Treatment	2 years: Excellent	550 participants
All Subjects	Investigator Assessment of Tolerability of Xalatan® Treatment	2 years: Very good	2203 participants
All Subjects	Investigator Assessment of Tolerability of Xalatan® Treatment	2 years: Good	1795 participants
All Subjects	Investigator Assessment of Tolerability of Xalatan® Treatment	2 years: Moderate	96 participants
All Subjects	Investigator Assessment of Tolerability of Xalatan® Treatment	2 years: Sufficient	7 participants
All Subjects	Investigator Assessment of Tolerability of Xalatan® Treatment	2 years: Insufficient	2 participants
All Subjects	Investigator Assessment of Tolerability of Xalatan® Treatment	2 years: Missing values	2 participants
All Subjects	Investigator Assessment of Tolerability of Xalatan® Treatment	3 years: Excellent	284 participants
All Subjects	Investigator Assessment of Tolerability of Xalatan® Treatment	3 years: Very good	1571 participants
All Subjects	Investigator Assessment of Tolerability of Xalatan® Treatment	3 years: Good	1281 participants
All Subjects	Investigator Assessment of Tolerability of Xalatan® Treatment	3 years: Moderate	69 participants
All Subjects	Investigator Assessment of Tolerability of Xalatan® Treatment	3 years: Sufficient	8 participants
All Subjects	Investigator Assessment of Tolerability of Xalatan® Treatment	3 years: Insufficient	2 participants
All Subjects	Investigator Assessment of Tolerability of Xalatan® Treatment	3 years: Missing values	2 participants

Secondary

Investigator Assessment of Xalatan® Efficacy

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

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

Arm	Measure	Group	Value (NUMBER)
All Subjects	Investigator Assessment of Xalatan® Efficacy	Baseline: Excellent	555 participants
All Subjects	Investigator Assessment of Xalatan® Efficacy	Baseline: Very good	978 participants
All Subjects	Investigator Assessment of Xalatan® Efficacy	Baseline: Good	538 participants
All Subjects	Investigator Assessment of Xalatan® Efficacy	Baseline: Moderate	92 participants
All Subjects	Investigator Assessment of Xalatan® Efficacy	Baseline: Sufficient	15 participants
All Subjects	Investigator Assessment of Xalatan® Efficacy	Baseline: Insufficient	23 participants
All Subjects	Investigator Assessment of Xalatan® Efficacy	Baseline: missing values	11285 participants
All Subjects	Investigator Assessment of Xalatan® Efficacy	1 year: Excellent	910 participants
All Subjects	Investigator Assessment of Xalatan® Efficacy	1 year: Very good	3216 participants
All Subjects	Investigator Assessment of Xalatan® Efficacy	1 year: Good	2489 participants
All Subjects	Investigator Assessment of Xalatan® Efficacy	1 year: Moderate	310 participants
All Subjects	Investigator Assessment of Xalatan® Efficacy	1 year: Sufficient	30 participants
All Subjects	Investigator Assessment of Xalatan® Efficacy	1 year: Insufficient	34 participants
All Subjects	Investigator Assessment of Xalatan® Efficacy	1 year: missing values	3 participants
All Subjects	Investigator Assessment of Xalatan® Efficacy	2 years: Excellent	475 participants
All Subjects	Investigator Assessment of Xalatan® Efficacy	2 years: Very good	2153 participants
All Subjects	Investigator Assessment of Xalatan® Efficacy	2 years: Good	1828 participants
All Subjects	Investigator Assessment of Xalatan® Efficacy	2 years: Moderate	164 participants
All Subjects	Investigator Assessment of Xalatan® Efficacy	2 years: Sufficient	23 participants
All Subjects	Investigator Assessment of Xalatan® Efficacy	2 years: Insufficient	10 participants
All Subjects	Investigator Assessment of Xalatan® Efficacy	2 years: missing values	2 participants
All Subjects	Investigator Assessment of Xalatan® Efficacy	3 years: Excellent	256 participants
All Subjects	Investigator Assessment of Xalatan® Efficacy	3 years: Very good	1548 participants
All Subjects	Investigator Assessment of Xalatan® Efficacy	3 years: Good	1307 participants
All Subjects	Investigator Assessment of Xalatan® Efficacy	3 years: Moderate	74 participants
All Subjects	Investigator Assessment of Xalatan® Efficacy	3 years: Sufficient	19 participants
All Subjects	Investigator Assessment of Xalatan® Efficacy	3 years: Insufficient	11 participants
All Subjects	Investigator Assessment of Xalatan® Efficacy	3 years: missing values	2 participants

Secondary

Reasons for Changes in Glaucoma Therapy

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

Population: 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	Measure	Group	Value (NUMBER)
All Subjects	Reasons for Changes in Glaucoma Therapy	Wish for better compliance	1055 participants
All Subjects	Reasons for Changes in Glaucoma Therapy	Wish for stronger IOP decrease	3474 participants
All Subjects	Reasons for Changes in Glaucoma Therapy	Wish for better local tolerability	787 participants
All Subjects	Reasons for Changes in Glaucoma Therapy	Wish for better systemic tolerability	504 participants
All Subjects	Reasons for Changes in Glaucoma Therapy	No medication until now	490 participants
All Subjects	Reasons for Changes in Glaucoma Therapy	Other reason	284 participants
All Subjects	Reasons for Changes in Glaucoma Therapy	Missing values	3859 participants

Secondary

Reasons for Discontinuation From Study

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

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

Arm	Measure	Group	Value (NUMBER)
All Subjects	Reasons for Discontinuation From Study	Subject's death	589 participants
All Subjects	Reasons for Discontinuation From Study	Lost to follow-up	717 participants
All Subjects	Reasons for Discontinuation From Study	Subject moved	320 participants
All Subjects	Reasons for Discontinuation From Study	Adverse event	337 participants
All Subjects	Reasons for Discontinuation From Study	Other reason	302 participants

Secondary

Subject Assessment of Satisfaction With Xalatan® Treatment

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

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

Arm	Measure	Group	Value (NUMBER)
All Subjects	Subject Assessment of Satisfaction With Xalatan® Treatment	Baseline: Excellent	901 participants
All Subjects	Subject Assessment of Satisfaction With Xalatan® Treatment	Baseline: Very good	737 participants
All Subjects	Subject Assessment of Satisfaction With Xalatan® Treatment	Baseline: Good	404 participants
All Subjects	Subject Assessment of Satisfaction With Xalatan® Treatment	Baseline: Moderate	35 participants
All Subjects	Subject Assessment of Satisfaction With Xalatan® Treatment	Baseline: Sufficient	110 participants
All Subjects	Subject Assessment of Satisfaction With Xalatan® Treatment	Baseline: Insufficient	7 participants
All Subjects	Subject Assessment of Satisfaction With Xalatan® Treatment	Baseline: missing values	11292 participants
All Subjects	Subject Assessment of Satisfaction With Xalatan® Treatment	1 year: Excellent	1078 participants
All Subjects	Subject Assessment of Satisfaction With Xalatan® Treatment	1 year: Very good	3200 participants
All Subjects	Subject Assessment of Satisfaction With Xalatan® Treatment	1 year: Good	2510 participants
All Subjects	Subject Assessment of Satisfaction With Xalatan® Treatment	1 year: Moderate	169 participants
All Subjects	Subject Assessment of Satisfaction With Xalatan® Treatment	1 year: Sufficient	16 participants
All Subjects	Subject Assessment of Satisfaction With Xalatan® Treatment	1 year: Insufficient	16 participants
All Subjects	Subject Assessment of Satisfaction With Xalatan® Treatment	1 year: missing values	3 participants
All Subjects	Subject Assessment of Satisfaction With Xalatan® Treatment	2 years: Excellent	621 participants
All Subjects	Subject Assessment of Satisfaction With Xalatan® Treatment	2 years: Very good	2082 participants
All Subjects	Subject Assessment of Satisfaction With Xalatan® Treatment	2 years: Good	1832 participants
All Subjects	Subject Assessment of Satisfaction With Xalatan® Treatment	2 years: Moderate	106 participants
All Subjects	Subject Assessment of Satisfaction With Xalatan® Treatment	2 years: Sufficient	8 participants
All Subjects	Subject Assessment of Satisfaction With Xalatan® Treatment	2 years: Insufficient	4 participants
All Subjects	Subject Assessment of Satisfaction With Xalatan® Treatment	2 years: missing values	2 participants
All Subjects	Subject Assessment of Satisfaction With Xalatan® Treatment	3 years: Excellent	343 participants
All Subjects	Subject Assessment of Satisfaction With Xalatan® Treatment	3 years: Very good	1499 participants
All Subjects	Subject Assessment of Satisfaction With Xalatan® Treatment	3 years: Good	1309 participants
All Subjects	Subject Assessment of Satisfaction With Xalatan® Treatment	3 years: Moderate	54 participants
All Subjects	Subject Assessment of Satisfaction With Xalatan® Treatment	3 years: Sufficient	7 participants
All Subjects	Subject Assessment of Satisfaction With Xalatan® Treatment	3 years: Insufficient	3 participants
All Subjects	Subject Assessment of Satisfaction With Xalatan® Treatment	3 years: missing values	2 participants

Secondary

Subject Self-care: Application of Eye Drops

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

Population: All subjects group; not summarized by subgroups

Arm	Measure	Group	Value (NUMBER)
All Subjects	Subject Self-care: Application of Eye Drops	Baseline: apply without help	16520 participants
All Subjects	Subject Self-care: Application of Eye Drops	Baseline: apply with help	1142 participants
All Subjects	Subject Self-care: Application of Eye Drops	Baseline: missing values	11150 participants
All Subjects	Subject Self-care: Application of Eye Drops	1 year: apply without help	12415 participants
All Subjects	Subject Self-care: Application of Eye Drops	1 year: apply with help	919 participants
All Subjects	Subject Self-care: Application of Eye Drops	1 year: missing values	3770 participants
All Subjects	Subject Self-care: Application of Eye Drops	2 years: apply without help	8657 participants
All Subjects	Subject Self-care: Application of Eye Drops	2 years: apply with help	391 participants
All Subjects	Subject Self-care: Application of Eye Drops	2 years: missing values	3153 participants
All Subjects	Subject Self-care: Application of Eye Drops	3 years: apply without help	5829 participants
All Subjects	Subject Self-care: Application of Eye Drops	3 years: apply with help	265 participants
All Subjects	Subject Self-care: Application of Eye Drops	3 years: missing values	2406 participants

Secondary

Visual Acuity (Visus)

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

Population: All subjects group and all treatment groups populations

Arm	Measure	Group	Value (NUMBER)
All Subjects	Visual Acuity (Visus)	1 year: Amaurosis	9 participants
All Subjects	Visual Acuity (Visus)	Baseline: Hand movements	503 participants
All Subjects	Visual Acuity (Visus)	Baseline: Finger count	241 participants
All Subjects	Visual Acuity (Visus)	Baseline: 0.05	766 participants
All Subjects	Visual Acuity (Visus)	Baseline: 0.1	553 participants
All Subjects	Visual Acuity (Visus)	Baseline: 0.2	759 participants
All Subjects	Visual Acuity (Visus)	Baseline: 0.3	902 participants
All Subjects	Visual Acuity (Visus)	Baseline: 0.4	1345 participants
All Subjects	Visual Acuity (Visus)	Baseline: 0.5	2173 participants
All Subjects	Visual Acuity (Visus)	Baseline: 0.6	2780 participants
All Subjects	Visual Acuity (Visus)	Baseline: 0.7	1799 participants
All Subjects	Visual Acuity (Visus)	Baseline: 0.8	4984 participants
All Subjects	Visual Acuity (Visus)	Baseline: 0.9	1880 participants
All Subjects	Visual Acuity (Visus)	Baseline: 1.0	8685 participants
All Subjects	Visual Acuity (Visus)	Baseline: 1.1	62 participants
All Subjects	Visual Acuity (Visus)	Baseline: 1.2	513 participants
All Subjects	Visual Acuity (Visus)	Baseline: >1.2	117 participants
All Subjects	Visual Acuity (Visus)	Baseline: Missing values	734 participants
All Subjects	Visual Acuity (Visus)	Baseline: Amaurosis	16 participants
All Subjects	Visual Acuity (Visus)	1 year: Hand movements	319 participants
All Subjects	Visual Acuity (Visus)	1 year: Finger counts	179 participants
All Subjects	Visual Acuity (Visus)	1 year: 0.05	291 participants
All Subjects	Visual Acuity (Visus)	1 year: 0.1	238 participants
All Subjects	Visual Acuity (Visus)	1 year: 0.2	381 participants
All Subjects	Visual Acuity (Visus)	1 year: 0.3	484 participants
All Subjects	Visual Acuity (Visus)	1 year: 0.4	720 participants
All Subjects	Visual Acuity (Visus)	1 year: 0.5	1225 participants
All Subjects	Visual Acuity (Visus)	1 year: 0.6	1663 participants
All Subjects	Visual Acuity (Visus)	1 year: 0.7	1087 participants
All Subjects	Visual Acuity (Visus)	1 year: 0.8	2872 participants
All Subjects	Visual Acuity (Visus)	1 year: 0.9	1152 participants
All Subjects	Visual Acuity (Visus)	1 year: 1.0	4687 participants
All Subjects	Visual Acuity (Visus)	1 year: 1.1	39 participants
All Subjects	Visual Acuity (Visus)	1 year: 1.2	322 participants
All Subjects	Visual Acuity (Visus)	1 year: >1.2	52 participants
All Subjects	Visual Acuity (Visus)	1 year: Missing values	1384 participants
All Subjects	Visual Acuity (Visus)	2 years: Amaurosis	9 participants
All Subjects	Visual Acuity (Visus)	2 years: Hand movements	214 participants
All Subjects	Visual Acuity (Visus)	2 years: Finger counts	126 participants
All Subjects	Visual Acuity (Visus)	2 years: 0.05	191 participants
All Subjects	Visual Acuity (Visus)	2 years: 0.1	188 participants
All Subjects	Visual Acuity (Visus)	2 years: 0.2	263 participants
All Subjects	Visual Acuity (Visus)	2 years: 0.3	351 participants
All Subjects	Visual Acuity (Visus)	2 years: 0.4	470 participants
All Subjects	Visual Acuity (Visus)	2 years: 0.5	856 participants
All Subjects	Visual Acuity (Visus)	2 years: 0.6	1167 participants
All Subjects	Visual Acuity (Visus)	2 years: 0.7	738 participants
All Subjects	Visual Acuity (Visus)	2 years: 0.8	2051 participants
All Subjects	Visual Acuity (Visus)	2 years: 0.9	900 participants
All Subjects	Visual Acuity (Visus)	2 years 1.0	3437 participants
All Subjects	Visual Acuity (Visus)	2 years: 1.1	29 participants
All Subjects	Visual Acuity (Visus)	3 years: Finger counts	82 participants
All Subjects	Visual Acuity (Visus)	2 years: 1.2	234 participants
All Subjects	Visual Acuity (Visus)	2 years: >1.2	22 participants
All Subjects	Visual Acuity (Visus)	2 years: Missing values	955 participants
All Subjects	Visual Acuity (Visus)	3 years: Amaurosis	4 participants
All Subjects	Visual Acuity (Visus)	3 years: Hand movements	133 participants
All Subjects	Visual Acuity (Visus)	3 years: 0.05	134 participants
All Subjects	Visual Acuity (Visus)	3 years: 0.1	137 participants
All Subjects	Visual Acuity (Visus)	3 years: 0.2	194 participants
All Subjects	Visual Acuity (Visus)	3 years: 0.3	227 participants
All Subjects	Visual Acuity (Visus)	3 years: 0.4	342 participants
All Subjects	Visual Acuity (Visus)	3 years: 0.5	606 participants
All Subjects	Visual Acuity (Visus)	3 years: 0.6	789 participants
All Subjects	Visual Acuity (Visus)	3 years: 0.7	534 participants
All Subjects	Visual Acuity (Visus)	3 years: 0.8	1369 participants
All Subjects	Visual Acuity (Visus)	3 years: 0.9	593 participants
All Subjects	Visual Acuity (Visus)	3 years: 1.0	2487 participants
All Subjects	Visual Acuity (Visus)	3 years: 1.1	24 participants
All Subjects	Visual Acuity (Visus)	3 years: 1.2	170 participants
All Subjects	Visual Acuity (Visus)	3 years: >1.2	13 participants
All Subjects	Visual Acuity (Visus)	3 years: Missing values	662 participants
Xalatan®	Visual Acuity (Visus)	1 year: Finger counts	51 participants
Xalatan®	Visual Acuity (Visus)	Baseline: 1.2	258 participants
Xalatan®	Visual Acuity (Visus)	2 years: 0.5	309 participants
Xalatan®	Visual Acuity (Visus)	1 year: 0.1	74 participants
Xalatan®	Visual Acuity (Visus)	3 years: 0.05	26 participants
Xalatan®	Visual Acuity (Visus)	2 years: 0.6	385 participants
Xalatan®	Visual Acuity (Visus)	Baseline: 1.0	4505 participants
Xalatan®	Visual Acuity (Visus)	2 years: 0.7	255 participants
Xalatan®	Visual Acuity (Visus)	3 years: Hand movements	33 participants
Xalatan®	Visual Acuity (Visus)	2 years: 0.8	775 participants
Xalatan®	Visual Acuity (Visus)	3 years: 0.5	207 participants
Xalatan®	Visual Acuity (Visus)	3 years: 1.0	1147 participants
Xalatan®	Visual Acuity (Visus)	2 years: 0.9	352 participants
Xalatan®	Visual Acuity (Visus)	1 year: 0.2	127 participants
Xalatan®	Visual Acuity (Visus)	3 years: Amaurosis	1 participants
Xalatan®	Visual Acuity (Visus)	2 years 1.0	1607 participants
Xalatan®	Visual Acuity (Visus)	3 years: 0.3	65 participants
Xalatan®	Visual Acuity (Visus)	2 years: 1.1	22 participants
Xalatan®	Visual Acuity (Visus)	2 years: Missing values	335 participants
Xalatan®	Visual Acuity (Visus)	3 years: Finger counts	26 participants
Xalatan®	Visual Acuity (Visus)	Baseline: 0.6	1242 participants
Xalatan®	Visual Acuity (Visus)	3 years: Missing values	243 participants
Xalatan®	Visual Acuity (Visus)	2 years: 1.2	97 participants
Xalatan®	Visual Acuity (Visus)	2 years: >1.2	7 participants
Xalatan®	Visual Acuity (Visus)	3 years: 1.1	18 participants
Xalatan®	Visual Acuity (Visus)	1 year: 0.3	160 participants
Xalatan®	Visual Acuity (Visus)	Baseline: Missing values	382 participants
Xalatan®	Visual Acuity (Visus)	1 year: 0.4	270 participants
Xalatan®	Visual Acuity (Visus)	Baseline: 0.5	941 participants
Xalatan®	Visual Acuity (Visus)	1 year: 0.5	463 participants
Xalatan®	Visual Acuity (Visus)	3 years: 0.2	53 participants
Xalatan®	Visual Acuity (Visus)	3 years: >1.2	5 participants
Xalatan®	Visual Acuity (Visus)	1 year: 0.6	625 participants
Xalatan®	Visual Acuity (Visus)	3 years: 0.4	107 participants
Xalatan®	Visual Acuity (Visus)	3 years: 0.6	258 participants
Xalatan®	Visual Acuity (Visus)	1 year: 0.7	418 participants
Xalatan®	Visual Acuity (Visus)	1 year: Amaurosis	0 participants
Xalatan®	Visual Acuity (Visus)	Baseline: 0.4	567 participants
Xalatan®	Visual Acuity (Visus)	1 year: 0.8	1161 participants
Xalatan®	Visual Acuity (Visus)	Baseline: 1.1	42 participants
Xalatan®	Visual Acuity (Visus)	1 year: 0.9	489 participants
Xalatan®	Visual Acuity (Visus)	Baseline: 0.9	928 participants
Xalatan®	Visual Acuity (Visus)	Baseline: 0.3	355 participants
Xalatan®	Visual Acuity (Visus)	1 year: 1.0	2242 participants
Xalatan®	Visual Acuity (Visus)	1 year: Hand movements	97 participants
Xalatan®	Visual Acuity (Visus)	1 year: 1.1	28 participants
Xalatan®	Visual Acuity (Visus)	Baseline: 0.2	308 participants
Xalatan®	Visual Acuity (Visus)	3 years: 0.7	185 participants
Xalatan®	Visual Acuity (Visus)	1 year: 1.2	152 participants
Xalatan®	Visual Acuity (Visus)	1 year: >1.2	28 participants
Xalatan®	Visual Acuity (Visus)	Baseline: 0.1	194 participants
Xalatan®	Visual Acuity (Visus)	1 year: Missing values	521 participants
Xalatan®	Visual Acuity (Visus)	2 years: 0.4	150 participants
Xalatan®	Visual Acuity (Visus)	2 years: Amaurosis	1 participants
Xalatan®	Visual Acuity (Visus)	Baseline: 0.05	238 participants
Xalatan®	Visual Acuity (Visus)	2 years: Hand movements	53 participants
Xalatan®	Visual Acuity (Visus)	Baseline: >1.2	77 participants
Xalatan®	Visual Acuity (Visus)	3 years: 0.1	34 participants
Xalatan®	Visual Acuity (Visus)	3 years: 0.8	538 participants
Xalatan®	Visual Acuity (Visus)	2 years: Finger counts	31 participants
Xalatan®	Visual Acuity (Visus)	Baseline: 0.8	2329 participants
Xalatan®	Visual Acuity (Visus)	2 years: 0.05	41 participants
Xalatan®	Visual Acuity (Visus)	Baseline: Finger count	94 participants
Xalatan®	Visual Acuity (Visus)	1 year: 0.05	86 participants
Xalatan®	Visual Acuity (Visus)	2 years: 0.1	52 participants
Xalatan®	Visual Acuity (Visus)	3 years: 1.2	61 participants
Xalatan®	Visual Acuity (Visus)	2 years: 0.2	72 participants
Xalatan®	Visual Acuity (Visus)	Baseline: Hand movements	176 participants
Xalatan®	Visual Acuity (Visus)	2 years: 0.3	111 participants
Xalatan®	Visual Acuity (Visus)	Baseline: 0.7	846 participants
Xalatan®	Visual Acuity (Visus)	Baseline: Amaurosis	4 participants
Xalatan®	Visual Acuity (Visus)	3 years: 0.9	210 participants
Betablockers	Visual Acuity (Visus)	Baseline: 0.05	17 participants
Betablockers	Visual Acuity (Visus)	2 years: 0.4	3 participants
Betablockers	Visual Acuity (Visus)	3 years: 0.6	7 participants
Betablockers	Visual Acuity (Visus)	3 years: 0.05	0 participants
Betablockers	Visual Acuity (Visus)	3 years: 0.9	1 participants
Betablockers	Visual Acuity (Visus)	2 years: 0.05	0 participants
Betablockers	Visual Acuity (Visus)	2 years: 0.5	5 participants
Betablockers	Visual Acuity (Visus)	1 year: 0.8	116 participants
Betablockers	Visual Acuity (Visus)	1 year: Amaurosis	0 participants
Betablockers	Visual Acuity (Visus)	1 year: 0.1	3 participants
Betablockers	Visual Acuity (Visus)	3 years: 1.2	0 participants
Betablockers	Visual Acuity (Visus)	2 years: 0.6	41 participants
Betablockers	Visual Acuity (Visus)	2 years: Amaurosis	0 participants
Betablockers	Visual Acuity (Visus)	3 years: Missing values	0 participants
Betablockers	Visual Acuity (Visus)	3 years: Finger counts	0 participants
Betablockers	Visual Acuity (Visus)	Baseline: 0.7	107 participants
Betablockers	Visual Acuity (Visus)	2 years: 0.7	2 participants
Betablockers	Visual Acuity (Visus)	Baseline: 0.6	217 participants
Betablockers	Visual Acuity (Visus)	3 years: Hand movements	2 participants
Betablockers	Visual Acuity (Visus)	1 year: 0.9	5 participants
Betablockers	Visual Acuity (Visus)	1 year: Finger counts	5 participants
Betablockers	Visual Acuity (Visus)	2 years: 0.8	63 participants
Betablockers	Visual Acuity (Visus)	3 years: 0.4	3 participants
Betablockers	Visual Acuity (Visus)	3 years: Amaurosis	0 participants
Betablockers	Visual Acuity (Visus)	Baseline: 0.3	50 participants
Betablockers	Visual Acuity (Visus)	Baseline: Amaurosis	1 participants
Betablockers	Visual Acuity (Visus)	2 years: 0.9	4 participants
Betablockers	Visual Acuity (Visus)	2 years: Hand movements	0 participants
Betablockers	Visual Acuity (Visus)	1 year: 1.0	106 participants
Betablockers	Visual Acuity (Visus)	3 years: 1.0	16 participants
Betablockers	Visual Acuity (Visus)	2 years: 0.2	4 participants
Betablockers	Visual Acuity (Visus)	2 years 1.0	50 participants
Betablockers	Visual Acuity (Visus)	1 year: 0.2	9 participants
Betablockers	Visual Acuity (Visus)	2 years: Missing values	4 participants
Betablockers	Visual Acuity (Visus)	Baseline: 0.2	40 participants
Betablockers	Visual Acuity (Visus)	3 years: >1.2	0 participants
Betablockers	Visual Acuity (Visus)	Baseline: 1.1	8 participants
Betablockers	Visual Acuity (Visus)	Baseline: >1.2	1 participants
Betablockers	Visual Acuity (Visus)	3 years: 1.1	0 participants
Betablockers	Visual Acuity (Visus)	1 year: 1.1	0 participants
Betablockers	Visual Acuity (Visus)	2 years: 1.1	0 participants
Betablockers	Visual Acuity (Visus)	1 year: Hand movements	1 participants
Betablockers	Visual Acuity (Visus)	2 years: >1.2	0 participants
Betablockers	Visual Acuity (Visus)	2 years: 0.1	0 participants
Betablockers	Visual Acuity (Visus)	1 year: 0.05	2 participants
Betablockers	Visual Acuity (Visus)	2 years: 1.2	0 participants
Betablockers	Visual Acuity (Visus)	3 years: 0.5	8 participants
Betablockers	Visual Acuity (Visus)	2 years: Finger counts	4 participants
Betablockers	Visual Acuity (Visus)	1 year: 1.2	0 participants
Betablockers	Visual Acuity (Visus)	3 years: 0.3	4 participants
Betablockers	Visual Acuity (Visus)	1 year: 0.3	9 participants
Betablockers	Visual Acuity (Visus)	Baseline: 0.1	25 participants
Betablockers	Visual Acuity (Visus)	3 years: 0.2	1 participants
Betablockers	Visual Acuity (Visus)	Baseline: Missing values	14 participants
Betablockers	Visual Acuity (Visus)	3 years: 0.7	3 participants
Betablockers	Visual Acuity (Visus)	1 year: 0.4	7 participants
Betablockers	Visual Acuity (Visus)	Baseline: 1.2	23 participants
Betablockers	Visual Acuity (Visus)	Baseline: 0.5	138 participants
Betablockers	Visual Acuity (Visus)	2 years: 0.3	0 participants
Betablockers	Visual Acuity (Visus)	1 year: >1.2	1 participants
Betablockers	Visual Acuity (Visus)	1 year: 0.5	19 participants
Betablockers	Visual Acuity (Visus)	Baseline: 0.9	130 participants
Betablockers	Visual Acuity (Visus)	Baseline: 0.8	395 participants
Betablockers	Visual Acuity (Visus)	Baseline: Finger count	15 participants
Betablockers	Visual Acuity (Visus)	Baseline: 1.0	613 participants
Betablockers	Visual Acuity (Visus)	1 year: 0.6	68 participants
Betablockers	Visual Acuity (Visus)	3 years: 0.8	16 participants
Betablockers	Visual Acuity (Visus)	Baseline: 0.4	62 participants
Betablockers	Visual Acuity (Visus)	1 year: Missing values	14 participants
Betablockers	Visual Acuity (Visus)	Baseline: Hand movements	28 participants
Betablockers	Visual Acuity (Visus)	1 year: 0.7	1 participants
Betablockers	Visual Acuity (Visus)	3 years: 0.1	3 participants
Xalacom®	Visual Acuity (Visus)	3 years: Hand movements	0 participants
Xalacom®	Visual Acuity (Visus)	Baseline: 1.1	1 participants
Xalacom®	Visual Acuity (Visus)	3 years: 0.3	0 participants
Xalacom®	Visual Acuity (Visus)	Baseline: 1.2	13 participants
Xalacom®	Visual Acuity (Visus)	Baseline: >1.2	5 participants
Xalacom®	Visual Acuity (Visus)	Baseline: Missing values	8 participants
Xalacom®	Visual Acuity (Visus)	1 year: Amaurosis	1 participants
Xalacom®	Visual Acuity (Visus)	1 year: Hand movements	5 participants
Xalacom®	Visual Acuity (Visus)	3 years: 0.4	5 participants
Xalacom®	Visual Acuity (Visus)	1 year: Finger counts	6 participants
Xalacom®	Visual Acuity (Visus)	1 year: 0.05	9 participants
Xalacom®	Visual Acuity (Visus)	3 years: Missing values	0 participants
Xalacom®	Visual Acuity (Visus)	1 year: 0.1	7 participants
Xalacom®	Visual Acuity (Visus)	1 year: 0.2	4 participants
Xalacom®	Visual Acuity (Visus)	1 year: 0.3	7 participants
Xalacom®	Visual Acuity (Visus)	3 years: 0.5	5 participants
Xalacom®	Visual Acuity (Visus)	1 year: 0.4	13 participants
Xalacom®	Visual Acuity (Visus)	1 year: 0.5	23 participants
Xalacom®	Visual Acuity (Visus)	1 year: 0.6	38 participants
Xalacom®	Visual Acuity (Visus)	1 year: 0.7	23 participants
Xalacom®	Visual Acuity (Visus)	1 year: 0.8	57 participants
Xalacom®	Visual Acuity (Visus)	3 years: 0.6	9 participants
Xalacom®	Visual Acuity (Visus)	2 years: Amaurosis	1 participants
Xalacom®	Visual Acuity (Visus)	1 year: 0.9	26 participants
Xalacom®	Visual Acuity (Visus)	1 year: 1.0	78 participants
Xalacom®	Visual Acuity (Visus)	1 year: 1.1	0 participants
Xalacom®	Visual Acuity (Visus)	1 year: 1.2	5 participants
Xalacom®	Visual Acuity (Visus)	1 year: >1.2	2 participants
Xalacom®	Visual Acuity (Visus)	3 years: 0.7	1 participants
Xalacom®	Visual Acuity (Visus)	1 year: Missing values	23 participants
Xalacom®	Visual Acuity (Visus)	3 years: >1.2	1 participants
Xalacom®	Visual Acuity (Visus)	2 years: Hand movements	2 participants
Xalacom®	Visual Acuity (Visus)	2 years: Finger counts	1 participants
Xalacom®	Visual Acuity (Visus)	2 years: 0.05	4 participants
Xalacom®	Visual Acuity (Visus)	3 years: 0.8	19 participants
Xalacom®	Visual Acuity (Visus)	2 years: 0.1	3 participants
Xalacom®	Visual Acuity (Visus)	2 years: 0.2	2 participants
Xalacom®	Visual Acuity (Visus)	2 years: 0.3	3 participants
Xalacom®	Visual Acuity (Visus)	2 years: 0.4	6 participants
Xalacom®	Visual Acuity (Visus)	2 years: 0.5	14 participants
Xalacom®	Visual Acuity (Visus)	3 years: 0.9	3 participants
Xalacom®	Visual Acuity (Visus)	2 years: 0.6	16 participants
Xalacom®	Visual Acuity (Visus)	2 years: 0.7	5 participants
Xalacom®	Visual Acuity (Visus)	2 years: 0.8	28 participants
Xalacom®	Visual Acuity (Visus)	2 years: 0.9	9 participants
Xalacom®	Visual Acuity (Visus)	2 years 1.0	33 participants
Xalacom®	Visual Acuity (Visus)	3 years: 1.0	13 participants
Xalacom®	Visual Acuity (Visus)	2 years: 1.1	0 participants
Xalacom®	Visual Acuity (Visus)	2 years: 1.2	4 participants
Xalacom®	Visual Acuity (Visus)	2 years: >1.2	1 participants
Xalacom®	Visual Acuity (Visus)	2 years: Missing values	7 participants
Xalacom®	Visual Acuity (Visus)	3 years: 1.1	0 participants
Xalacom®	Visual Acuity (Visus)	3 years: Amaurosis	0 participants
Xalacom®	Visual Acuity (Visus)	3 years: Finger counts	0 participants
Xalacom®	Visual Acuity (Visus)	3 years: 0.05	2 participants
Xalacom®	Visual Acuity (Visus)	Baseline: Amaurosis	1 participants
Xalacom®	Visual Acuity (Visus)	Baseline: Hand movements	15 participants
Xalacom®	Visual Acuity (Visus)	Baseline: Finger count	9 participants
Xalacom®	Visual Acuity (Visus)	Baseline: 0.05	26 participants
Xalacom®	Visual Acuity (Visus)	Baseline: 0.1	11 participants
Xalacom®	Visual Acuity (Visus)	3 years: 0.1	3 participants
Xalacom®	Visual Acuity (Visus)	Baseline: 0.2	12 participants
Xalacom®	Visual Acuity (Visus)	Baseline: 0.3	27 participants
Xalacom®	Visual Acuity (Visus)	Baseline: 0.4	33 participants
Xalacom®	Visual Acuity (Visus)	Baseline: 0.5	56 participants
Xalacom®	Visual Acuity (Visus)	Baseline: 0.6	84 participants
Xalacom®	Visual Acuity (Visus)	3 years: 0.2	1 participants
Xalacom®	Visual Acuity (Visus)	Baseline: 0.7	41 participants
Xalacom®	Visual Acuity (Visus)	Baseline: 0.8	132 participants
Xalacom®	Visual Acuity (Visus)	3 years: 1.2	1 participants
Xalacom®	Visual Acuity (Visus)	Baseline: 0.9	50 participants
Xalacom®	Visual Acuity (Visus)	Baseline: 1.0	222 participants
Other Medications	Visual Acuity (Visus)	Baseline: 0.7	805 participants
Other Medications	Visual Acuity (Visus)	2 years: 0.3	108 participants
Other Medications	Visual Acuity (Visus)	3 years: >1.2	0 participants
Other Medications	Visual Acuity (Visus)	3 years: 0.2	61 participants
Other Medications	Visual Acuity (Visus)	Baseline: Amaurosis	10 participants
Other Medications	Visual Acuity (Visus)	3 years: 0.05	57 participants
Other Medications	Visual Acuity (Visus)	2 years: 0.2	90 participants
Other Medications	Visual Acuity (Visus)	3 years: 0.8	260 participants
Other Medications	Visual Acuity (Visus)	1 year: Finger counts	79 participants
Other Medications	Visual Acuity (Visus)	Baseline: Hand movements	284 participants
Other Medications	Visual Acuity (Visus)	2 years: 0.1	71 participants
Other Medications	Visual Acuity (Visus)	2 years: 0.05	80 participants
Other Medications	Visual Acuity (Visus)	2 years: Finger counts	49 participants
Other Medications	Visual Acuity (Visus)	1 year: Hand movements	153 participants
Other Medications	Visual Acuity (Visus)	Baseline: Finger count	123 participants
Other Medications	Visual Acuity (Visus)	2 years: Hand movements	87 participants
Other Medications	Visual Acuity (Visus)	2 years: Amaurosis	0 participants
Other Medications	Visual Acuity (Visus)	3 years: 0.7	111 participants
Other Medications	Visual Acuity (Visus)	Baseline: 1.1	11 participants
Other Medications	Visual Acuity (Visus)	Baseline: 0.05	485 participants
Other Medications	Visual Acuity (Visus)	1 year: Missing values	555 participants
Other Medications	Visual Acuity (Visus)	1 year: >1.2	5 participants
Other Medications	Visual Acuity (Visus)	1 year: 1.2	70 participants
Other Medications	Visual Acuity (Visus)	Baseline: 0.8	2128 participants
Other Medications	Visual Acuity (Visus)	Baseline: 0.1	323 participants
Other Medications	Visual Acuity (Visus)	Baseline: 1.0	3345 participants
Other Medications	Visual Acuity (Visus)	1 year: 1.1	4 participants
Other Medications	Visual Acuity (Visus)	1 year: 1.0	844 participants
Other Medications	Visual Acuity (Visus)	1 year: Amaurosis	4 participants
Other Medications	Visual Acuity (Visus)	Baseline: 0.2	399 participants
Other Medications	Visual Acuity (Visus)	3 years: 0.1	43 participants
Other Medications	Visual Acuity (Visus)	3 years: 0.6	190 participants
Other Medications	Visual Acuity (Visus)	1 year: 0.9	224 participants
Other Medications	Visual Acuity (Visus)	Baseline: Missing values	330 participants
Other Medications	Visual Acuity (Visus)	Baseline: 0.3	470 participants
Other Medications	Visual Acuity (Visus)	1 year: 0.8	697 participants
Other Medications	Visual Acuity (Visus)	1 year: 0.7	301 participants
Other Medications	Visual Acuity (Visus)	1 year: 0.6	494 participants
Other Medications	Visual Acuity (Visus)	Baseline: 1.2	219 participants
Other Medications	Visual Acuity (Visus)	Baseline: 0.4	683 participants
Other Medications	Visual Acuity (Visus)	1 year: 0.5	334 participants
Other Medications	Visual Acuity (Visus)	3 years: 0.5	136 participants
Other Medications	Visual Acuity (Visus)	1 year: 0.4	233 participants
Other Medications	Visual Acuity (Visus)	Baseline: 0.9	772 participants
Other Medications	Visual Acuity (Visus)	Baseline: 0.5	1038 participants
Other Medications	Visual Acuity (Visus)	1 year: 0.3	180 participants
Other Medications	Visual Acuity (Visus)	1 year: 0.2	146 participants
Other Medications	Visual Acuity (Visus)	1 year: 0.1	79 participants
Other Medications	Visual Acuity (Visus)	3 years: 1.2	32 participants
Other Medications	Visual Acuity (Visus)	2 years: 1.2	41 participants
Other Medications	Visual Acuity (Visus)	2 years: 1.1	1 participants
Other Medications	Visual Acuity (Visus)	Baseline: 0.6	1237 participants
Other Medications	Visual Acuity (Visus)	2 years: >1.2	3 participants
Other Medications	Visual Acuity (Visus)	3 years: 1.0	347 participants
Other Medications	Visual Acuity (Visus)	3 years: Hand movements	47 participants
Other Medications	Visual Acuity (Visus)	2 years 1.0	536 participants
Other Medications	Visual Acuity (Visus)	Baseline: >1.2	34 participants
Other Medications	Visual Acuity (Visus)	2 years: Missing values	373 participants
Other Medications	Visual Acuity (Visus)	1 year: 0.05	120 participants
Other Medications	Visual Acuity (Visus)	2 years: 0.9	160 participants
Other Medications	Visual Acuity (Visus)	2 years: 0.8	424 participants
Other Medications	Visual Acuity (Visus)	3 years: 0.4	89 participants
Other Medications	Visual Acuity (Visus)	3 years: Amaurosis	2 participants
Other Medications	Visual Acuity (Visus)	3 years: 1.1	1 participants
Other Medications	Visual Acuity (Visus)	3 years: Missing values	258 participants
Other Medications	Visual Acuity (Visus)	2 years: 0.7	162 participants
Other Medications	Visual Acuity (Visus)	3 years: 0.9	85 participants
Other Medications	Visual Acuity (Visus)	3 years: 0.3	74 participants
Other Medications	Visual Acuity (Visus)	3 years: Finger counts	26 participants
Other Medications	Visual Acuity (Visus)	2 years: 0.6	327 participants
Other Medications	Visual Acuity (Visus)	2 years: 0.5	210 participants
Other Medications	Visual Acuity (Visus)	2 years: 0.4	145 participants

Secondary

Visual Impairment Due to Glaucoma

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

Population: All subjects group; not summarized by subgroups

Arm	Measure	Group	Value (NUMBER)
All Subjects	Visual Impairment Due to Glaucoma	Baseline: Not at all	9368 participants
All Subjects	Visual Impairment Due to Glaucoma	Baseline: A little bit	5171 participants
All Subjects	Visual Impairment Due to Glaucoma	Baseline: Moderate	1723 participants
All Subjects	Visual Impairment Due to Glaucoma	Baseline: Severe	627 participants
All Subjects	Visual Impairment Due to Glaucoma	Baseline: Very severe	235 participants
All Subjects	Visual Impairment Due to Glaucoma	Baseline: Missing values	11688 participants
All Subjects	Visual Impairment Due to Glaucoma	1 year: Not at all	7184 participants
All Subjects	Visual Impairment Due to Glaucoma	1 year: A little bit	4269 participants
All Subjects	Visual Impairment Due to Glaucoma	1 year: Moderate	836 participants
All Subjects	Visual Impairment Due to Glaucoma	1 year: Severe	284 participants
All Subjects	Visual Impairment Due to Glaucoma	1 year: Very severe	91 participants
All Subjects	Visual Impairment Due to Glaucoma	1 year: Missing values	4440 participants
All Subjects	Visual Impairment Due to Glaucoma	2 years: Not at all	4917 participants
All Subjects	Visual Impairment Due to Glaucoma	2 years: A little bit	2961 participants
All Subjects	Visual Impairment Due to Glaucoma	2 years: Moderate	715 participants
All Subjects	Visual Impairment Due to Glaucoma	2 years: Severe	156 participants
All Subjects	Visual Impairment Due to Glaucoma	2 years: Very severe	50 participants
All Subjects	Visual Impairment Due to Glaucoma	2 years: Missing values	3402 participants
All Subjects	Visual Impairment Due to Glaucoma	3 years: Not at all	3120 participants
All Subjects	Visual Impairment Due to Glaucoma	3 years: A little bit	2137 participants
All Subjects	Visual Impairment Due to Glaucoma	3 years: Moderate	501 participants
All Subjects	Visual Impairment Due to Glaucoma	3 years: Severe	110 participants
All Subjects	Visual Impairment Due to Glaucoma	3 years: Very severe	48 participants
All Subjects	Visual Impairment Due to Glaucoma	3 years: Missing values	2584 participants

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026

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

Conditions

Keywords

Brief summary

Related papers

Interventions

Sponsors

Study design

Eligibility

Inclusion criteria

Exclusion criteria

Design outcomes

Primary

Secondary

Participant flow

Recruitment details

Pre-assignment details

Participants by arm

Baseline characteristics

Adverse events

Outcome results

Aulhorn Stage (Visual Field Defects)

Change From Baseline in Intraocular Pressure (IOP)

Change From Baseline in Optic Disc Excavation: Horizontal Cup to Disc Ratio

Change From Baseline in Optic Disc Excavation: Vertical Cup to Disc Ratio

Changes to the Color of the Iris During Xalatan® or Xalacom® Treatment

Investigator Assessment of Tolerability of Xalatan® Treatment

Investigator Assessment of Xalatan® Efficacy

Reasons for Changes in Glaucoma Therapy

Reasons for Discontinuation From Study

Subject Assessment of Satisfaction With Xalatan® Treatment

Subject Self-care: Application of Eye Drops

Visual Acuity (Visus)

Visual Impairment Due to Glaucoma