N/A
N=28,812
Non-Interventional Study In Patients With Ocular Hypertension And Open Angle Glaucoma Treated With Xalatan And Xalacom
Glaucoma · Ocular Hypertension
Bottom Line
View on ClinicalTrials.gov: NCT01012245 ↗Enrolled (actual)
28,812
Serious AEs
0.0%
Results posted
Jan 2010
Primary outcome: Primary: Change From Baseline in Intraocular Pressure (IOP) — -1.5; -0.7; -1.0; -0.2 mm Hg
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- no intervention (Other)
- Age
- Pediatric, Adult, Older Adult
- Sex
- All
- Sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
- Primary completion
- Dec 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Intraocular Pressure (IOP) |
-1.5; -0.7; -1.0; -0.2; -1.1; -1.6 | — |
| PRIMARY Aulhorn Stage (Visual Field Defects) |
7753; 4074; 493; 200; 2986; 3759 | — |
| PRIMARY Change From Baseline in Optic Disc Excavation: Vertical Cup to Disc Ratio |
0.00; 0.00; 0.02; 0.01; 0.00; 0.01 | — |
| PRIMARY Change From Baseline in Optic Disc Excavation: Horizontal Cup to Disc Ratio |
0.00; 0.00; 0.02; 0.01; 0.00; 0.00 | — |
| SECONDARY Investigator Assessment of Xalatan® Efficacy |
555; 978; 538; 92; 15; 23 | — |
| SECONDARY Subject Assessment of Satisfaction With Xalatan® Treatment |
901; 737; 404; 35; 110; 7 | — |
| SECONDARY Visual Acuity (Visus) |
16; 4; 1; 1; 10; 503 | — |
| SECONDARY Visual Impairment Due to Glaucoma |
9368; 5171; 1723; 627; 235; 11688 | — |
| SECONDARY Subject Self-care: Application of Eye Drops |
16520; 1142; 11150; 12415; 919; 3770 | — |
| SECONDARY Reasons for Changes in Glaucoma Therapy |
1055; 3474; 787; 504; 490; 284 | — |
| SECONDARY Investigator Assessment of Tolerability of Xalatan® Treatment |
619; 1075; 449; 45; 4; 9 | — |
| SECONDARY Reasons for Discontinuation From Study |
717; 589; 320; 337; 302 | — |
| SECONDARY Changes to the Color of the Iris During Xalatan® or Xalacom® Treatment |
— | — |
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.
Eligibility Criteria
Inclusion Criteria
- patients with ocular hypertension or glaucoma, defined by SmPC
Exclusion Criteria
- defined by SmPC
Data sourced from ClinicalTrials.gov (NCT01012245). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.