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

Glaucoma Clinical Trial

— XCHANGE  

Official title:

Project "XCHANGE" Non-Interventional Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01012245
• Other study ID #: 912-OPT-0091-131
• Secondary ID: A6111100, 912-OP
• Status: Completed
• Start date: January 2000
• Est. completion date: December 2008

Study information

• Verified date: February 2010
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28812
• Est. completion date: December 2008
• Est. primary completion date: December 2008
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• patients with ocular hypertension or glaucoma, defined by SmPC

Exclusion Criteria:

• defined by SmPC

Related Conditions & MeSH terms

• Glaucoma
• Hypertension
• Ocular Hypertension

Intervention

Other:
• no intervention

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

Outcome

Type	Measure	Description	Time frame	Safety issue
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).	Baseline, 1 year, 2 years, and 3 years
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.	Baseline, 1 year, 2 years, and 3 years
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).	Baseline, 1 year, 2 years, and 3 years
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).	Baseline, 1 year, 2 years, and 3 years
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).	Baseline, 1 year, 2 years, and 3 years
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).	Baseline, 1 year, 2 years, and 3 years
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.	Baseline, 1 year, 2 years, and 3 years
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).	Baseline, 1 year, 2 years, and 3 years
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).	Baseline, 1 year, 2 years, and 3 years
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.	January 2000 through December 2008
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.	Baseline up to 3 years
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.	January 2000 through December 2008
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®.	Baseline up to 3 years

External Links

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