N/A
N=387
Observational Study of Lumigan® 0.01% Treatment for Patients With Primary Open Angle Glaucoma or Ocular Hypertension
Glaucoma, Open-Angle · Ocular Hypertension
Bottom Line
View on ClinicalTrials.gov: NCT01489670 ↗Enrolled (actual)
387
Serious AEs
0.0%
Results posted
Mar 2014
Primary outcome: Primary: Intraocular Pressure (IOP) at Baseline — 22.0; 22.0 mm Hg
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- bimatoprost 0.01% ophthalmic solution (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Allergan
- Primary completion
- Mar 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Intraocular Pressure (IOP) at Baseline |
22.0; 22.0 | — |
| PRIMARY Intraocular Pressure (IOP) at Week 12 |
16.0; 16.0 | — |
| SECONDARY Physician Evaluation of Efficacy Using a 5-Point Scale |
87; 187; 64; 6; 15 | — |
| SECONDARY Patient Evaluation of Tolerability of Treatment Using a 4-Point Scale |
157; 144; 7; 16 | — |
| SECONDARY Physician Evaluation of Tolerability of Treatment |
174; 141; 12; 6 | — |
| SECONDARY Physician Reported Reasons for Early Discontinuation of Treatment |
28; 21; 18; 8; 1; 6 | — |
| SECONDARY Number of Patients Continuing Treatment After 12 Weeks |
302 | — |
Summary
This study will assess the efficacy, safety, tolerability and persistence of use of Lumigan ® 0.01% in patients diagnosed with primary open-angle glaucoma or ocular hypertension who are treated per routine clinical practice.
Eligibility Criteria
Inclusion Criteria
- Diagnosis of primary open-angle glaucoma or ocular hypertension
- Lumigan® 0.01% prescribed either as monotherapy or adjunctive to beta-blocker therapy
Exclusion Criteria
- None
Data sourced from ClinicalTrials.gov (NCT01489670). 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.