N/A
N=1,830
A Study of Patients With Primary Open Angle Glaucoma or Ocular Hypertension Switched to Lumigan® UD Monotherapy for Medical Reasons
Glaucoma, Primary Open Angle · Ocular Hypertension
Bottom Line
View on ClinicalTrials.gov: NCT01853085 ↗Enrolled (actual)
1,830
Serious AEs
0.1%
Results posted
May 2015
Primary outcome: Primary: Intraocular Pressure (IOP) in the Study Eye at Baseline — 21.15 Millimeters of Mercury (mmHg)
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- Bimatoprost Ophthalmic Solution (Drug)
- Age
- Pediatric, Adult, Older Adult
- Sex
- All
- Sponsor
- Allergan
- Primary completion
- Mar 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Intraocular Pressure (IOP) in the Study Eye at Baseline |
21.15 | — |
| PRIMARY IOP in the Study Eye at Week 12 |
16.38 | — |
| SECONDARY Physician Assessment of IOP-Lowering Effect in the Study Eye on a 3-Point Scale |
649; 916; 151 | — |
| SECONDARY Patient Assessment of Tolerability on a 4-Point Scale |
913; 670; 73; 74 | — |
| SECONDARY Physician Assessment of Tolerability on a 4-Point Scale |
982; 648; 78; 38 | — |
| SECONDARY Number of Patients Who Discontinue Treatment With Lumigan® UD Prior to 12 Weeks of Treatment |
139 | — |
| SECONDARY Number of Patients Who Continue Treatment |
1501 | — |
| SECONDARY Physician Assessment of Patient Compliance Compared to Previous Treatment on a 3-Point Scale |
848; 777; 50 | — |
Summary
The study will evaluate patients diagnosed with primary open angle glaucoma or ocular hypertension who are switched to Lumigan® UD monotherapy for medical reasons in accordance with physician standard clinical practice. All treatment decisions lie with the physician.
Eligibility Criteria
Inclusion Criteria
- Diagnosed with primary open-angle glaucoma or ocular hypertension
- Previously prescribed intraocular pressure (IOP)-lowering medication with insufficient IOP control and is now being switched to Lumigan® UD for medical reasons
Exclusion Criteria
- None
Data sourced from ClinicalTrials.gov (NCT01853085). 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.