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

NCT01012245 | Completed Results

• 2 other identifiers: 912-OPT-0091-131A6111100, 912-OPT-0091-131
• Study Type: observational
• Target: 28,812
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Glaucoma; Ocular Hypertension

Keywords

Xchange; Xalatan; Xalacom; Betablocker; observational; longterm

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (9)

• Investigator Assessment of Xalatan® Efficacy

  Baseline, 1 year, 2 years, and 3 years

• Subject Assessment of Satisfaction With Xalatan® Treatment

  Baseline, 1 year, 2 years, and 3 years

• Visual Acuity (Visus)

  Baseline, 1 year, 2 years, and 3 years

• Visual Impairment Due to Glaucoma

  Baseline, 1 year, 2 years, and 3 years

• Subject Self-care: Application of Eye Drops

  Baseline, 1 year, 2 years, and 3 years

Study Arms (1)

patients with glaucoma and ocular hypertension

Other: no intervention

Interventions

no intervention OTHER

patients with glaucoma and ocular hypertension

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

patients with glaucoma or ocular hypertension treated by office-based ophthalmologists

You may qualify if:

• patients with ocular hypertension or glaucoma, defined by SmPC

You may not qualify if:

• defined by SmPC

Sponsors & Collaborators

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

Related Links

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

MeSH Terms

Conditions

Glaucoma; Ocular Hypertension

Condition Hierarchy (Ancestors)

Eye Diseases

Limitations and Caveats

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

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer, Inc.

ClinicalTrials.govCallCenter@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 11, 2009
• First Posted: November 13, 2009
• Study Start: January 1, 2000
• Primary Completion: December 1, 2008
• Study Completion: December 1, 2008
• Last Updated: February 25, 2021
• Results First Posted: January 21, 2010

Record last verified: 2010-02