Phase 4
Completed N=135
Safety and Efficacy of LUMIGAN® RC Versus DuoTrav® in Patients Who Require Further Intraocular Pressure (IOP) Reduction
Glaucoma, Open-Angle · Hypertension
Source: ClinicalTrials.gov NCT01547598 ↗
Enrolled (actual)
135
Serious AEs
0.4%
Results posted
Aug 2014
Primary outcomePrimary: Mean Diurnal Intraocular Pressure (IOP) — 18.6; 17.4 mmHg
Summary
This non-inferiority study will assess safety and efficacy of LUMIGAN® RC (bimatoprost ophthalmic solution 0.01%) versus DuoTrav® (travoprost 0.004%/timolol 0.5% combination ophthalmic solution) in patients previously on Travatan® Z (travoprost ophthalmic solution 0.004%) monotherapy.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Diurnal Intraocular Pressure (IOP) |
18.6; 17.4 | — |
| SECONDARY Change From Baseline in Mean IOP at Week 12 |
22.0; 22.0; -2.7; -4.5; 20.6; 20.3 | — |
| SECONDARY Percentage of Participants With ≥15% Reduction in Mean Diurnal IOP From Baseline |
26.2; 47.6 | — |
| SECONDARY Percentage of Participants With Mean Diurnal IOP Less Than 18 mmHg |
11.5; 17.5 | — |
| SECONDARY Change From Baseline in Mean IOP at Week 6 |
22.0; 22.0; -2.8; -4.8; 20.6; 20.3 | — |
Eligibility Criteria
Inclusion Criteria
- Open angle glaucoma or ocular hypertension
- Best corrected visual acuity of 20/100 or better in both eyes
Exclusion Criteria
- Ocular surgery within 3 months, or anticipated ocular surgery within 12 weeks
- Previous treatment with LUMIGAN® RC or DuoTrav®
- History of LASIK, LASEK, RK or PRK in the study eye(s)
- Active ocular inflammation
Data sourced from ClinicalTrials.gov (NCT01547598). 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.