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

Study Overview
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Brief Summary
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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.

Official Title
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Project XCHANGE Non-Interventional Study

Conditions
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Glaucoma, Ocular Hypertension

Intervention / Treatment
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* Other: no intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patients with ocular hypertension or glaucoma, defined by SmPC Exclusion Criteria: defined by SmPC
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| patients with glaucoma and ocular hypertension<br> | Other: no intervention<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | Baseline, 1 year, 2 years, and 3 years | 
| 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. | Baseline, 1 year, 2 years, and 3 years | 
| 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). | Baseline, 1 year, 2 years, and 3 years | 
| 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). | Baseline, 1 year, 2 years, and 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | Baseline, 1 year, 2 years, and 3 years | 
| 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). | Baseline, 1 year, 2 years, and 3 years | 
| 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. | Baseline, 1 year, 2 years, and 3 years | 
| 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). | Baseline, 1 year, 2 years, and 3 years | 
| 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). | Baseline, 1 year, 2 years, and 3 years | 
| 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. | January 2000 through December 2008 | 
| 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. | Baseline up to 3 years | 
| 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. | January 2000 through December 2008 | 
| 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®. | Baseline up to 3 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Xchange, Xalatan, Xalacom, Betablocker, observational, longterm