N/A
Completed N=633
Long Term Use Of Xalacom In Patients Glaucoma Or Ocular Hypertension
Source: ClinicalTrials.gov NCT01191008 ↗Enrolled (actual)
633
Serious AEs
2.1%
Results posted
Jul 2017
Primary outcomePrimary: Number of Participants WithTreatment-Related Adverse Events — 73 Participants
Summary
The objective of this Investigation is to evaluate the safety and efficacy of long-term treatment with Xalacom in medical practice. Also, occurrence of unknown and known adverse drug reactions (ADRs) in subjects treated with Xalacom will be monitored during the survey period, and whether an additional treatment outcome investigation and/or a post-marketing clinical study is required in the future will be determined.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants WithTreatment-Related Adverse Events |
73 | — |
| PRIMARY Clinical Effectiveness Rate |
82.8 | — |
Eligibility Criteria
Inclusion Criteria
- Patients need to be administered Xalacom® in order to be enrolled in the surveillance.
Exclusion Criteria
- Patients not administered Xalacom®.
Data sourced from ClinicalTrials.gov (NCT01191008). 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. Informational only — not medical advice.