Phase 3
Completed N=185
Safety and Efficacy of Triple Combination Therapy in Patients With Primary Open-Angle Glaucoma or Ocular Hypertension
Glaucoma, Open-Angle · Hypertension
Source: ClinicalTrials.gov NCT01217606 ↗
Enrolled (actual)
185
Serious AEs
1.1%
Results posted
Nov 2015
Primary outcomePrimary: Change From Baseline in Mean Worse Eye Intraocular Pressure (IOP) Analyzed by Two-Sample T-Test — 25.42; 24.43; -10.45; -8.28 Millimeters of Mercury (mmHg)
Summary
This study will evaluate the safety and efficacy of Triple Combination Therapy compared with Fixed Combination brimonidine tartrate/timolol ophthalmic solution in patients with primary open-angle glaucoma or ocular hypertension.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Mean Worse Eye Intraocular Pressure (IOP) Analyzed by Two-Sample T-Test |
25.42; 24.43; -10.45; -8.28 | — |
| SECONDARY Change From Baseline in Mean Worse Eye Intraocular Pressure (IOP) Analyzed by Mixed-Effect Model for Repeated Measure |
25.42; 24.43; -11.63; -8.13; -11.24; -8.12 | — |
| SECONDARY Change From Baseline in Mean Worse Eye Intraocular Pressure (IOP) Analyzed by Analysis of Covariance (ANCOVA) |
25.42; 24.43; -11.63; -8.13; -11.20; -8.28 | — |
Eligibility Criteria
Inclusion Criteria
- Ocular hypertension or primary open-angle glaucoma in each eye
- Requires treatment with IOP-lowering medication in both eyes
Exclusion Criteria
- Required chronic use of ocular medications during the study other than study medication
- Use of any corticosteroids within 30 days
- History of any traumatic eye surgeries
- Cataract surgery in the past 6 months
- Anticipated wearing of contact lenses during the study
Data sourced from ClinicalTrials.gov (NCT01217606). 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.