N/A
Completed N=933
Observational Study of Lumigan® 0.01% for Treatment of Primary Open Angle Glaucoma (POAG) or Ocular Hypertension (OHT)
Source: ClinicalTrials.gov NCT01568008 ↗Enrolled (actual)
933
Serious AEs
0.8%
Results posted
Sep 2013
Primary outcomePrimary: Intraocular Pressure (IOP) at Baseline — 22.04; 22.07 mm Hg
Summary
This is an observational study in patients with POAG or OHT that will collect data on the use of Lumigan® 0.01% (bimatoprost 0.01% ophthalmic solution) in a routine clinical setting. Patients will be seen at baseline and at a follow-up visit approximately 8-12 weeks after baseline, as per normal clinical practice.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Intraocular Pressure (IOP) at Baseline |
22.04; 22.07 | — |
| PRIMARY Intraocular Pressure (IOP) at Week 12 |
16.94; 17.02 | — |
| SECONDARY Patient Assessment of Treatment Tolerability Using a 4-Point Scale |
460; 317; 61; 50 | — |
| SECONDARY Physician Assessment of Treatment Tolerability Using a 4-Point Scale |
489; 331; 49; 24 | — |
| SECONDARY Physician Reported Reasons for Treatment Discontinuation |
46; 20; 11; 8; 6; 6 | — |
| SECONDARY Number of Patients Continuing Treatment After 12 Weeks |
755 | — |
Eligibility Criteria
Inclusion Criteria
- Diagnosis of POAG or OHT
- Prescribed Lumigan® 0.01%
Exclusion Criteria
- None
Data sourced from ClinicalTrials.gov (NCT01568008). 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.