Phase 3
Completed N=289
A Study Comparing Xalacom And Xalatan In Patients With Primary Open Angle Glaucoma (POAG) Or Ocular Hypertension (OH).
Source: ClinicalTrials.gov NCT00383019 ↗Enrolled (actual)
289
Serious AEs
1.0%
Results posted
May 2009
Primary outcomePrimary: Change of Intraocular Pressure (IOP) From Baseline to Week 8 — -2.59; -1.62 mmHg
Summary
This study will examine the efficacy and safety of Xalacom comparing with those of Xalatan in Japanese patients with POAG or OH, in order to show superiority of Xalacom over Xalatan in efficacy and similarity of safety between Xalacom and Xalatan.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change of Intraocular Pressure (IOP) From Baseline to Week 8 |
-2.59; -1.62 | — |
| SECONDARY Change of IOP From Baseline to Week 4 |
-2.50; -1.17 | — |
| SECONDARY Number of Subjects With an IOP of <=15 mmHg at Week 8 |
36; 13 | — |
| SECONDARY Number of Subjects With an IOP of <=16 mmHg at Week 8 |
60; 35 | — |
| SECONDARY Percent Change of IOP From Baseline to Week 8 |
-12.67; -7.69 | — |
| SECONDARY Number of Subjects With an IOP of <=18 mmHg at Week 8 |
105; 91 | — |
| SECONDARY Number of Subjects With an IOP Reduction of >=2 mmHg From Baseline to Week 8 |
95; 65 | — |
| SECONDARY Number of Subjects With an IOP Reduction of >=3 mmHg From Baseline to Week 8 |
66; 40 | — |
| SECONDARY Number of Subjects With an IOP of <=17 mmHg at Week 8 |
83; 60 | — |
Eligibility Criteria
Inclusion Criteria
- Intraocular pressure is 18 mmHg or more at baseline after treatment with Xalatan for 4 weeks or more.
Exclusion Criteria
- History of no-response to timolol
- History of trabeculectomy
- History of other ocular surgery including ALT, SLT,and trabeculotomy within 6 months
Data sourced from ClinicalTrials.gov (NCT00383019). 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.