Phase 4
Completed N=60
Efficacy of Changing to DUOTRAV® From Prior Therapy
Open-angle glaucoma · Hypertension · Pigment Dispersion Glaucoma
Source: ClinicalTrials.gov NCT01327599 ↗
Enrolled (actual)
60
Serious AEs
0.0%
Results posted
Jan 2014
Primary outcomePrimary: Mean Change From Baseline in IOP at Week 12 in Subjects Using Ganfort® at Baseline — 20.0; -3.8 millimeters mercury (mmHg)
Summary
The purpose of this study was to assess the efficacy and tolerability of changing to DUOTRAV® from prior bimatoprost 0.03%/timolol 0.5% pharmacotherapy in subjects with open-angle glaucoma or ocular hypertension having uncontrolled intraocular pressure (IOP).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Change From Baseline in IOP at Week 12 in Subjects Using Ganfort® at Baseline |
20.0; -3.8 | — |
| SECONDARY Mean Change From Baseline in Ocular Surface Disease Index (OSDI) Score at Week 12 in Subjects Using Ganfort® at Baseline |
14.9; -3.6 | — |
| SECONDARY Mean Change From Baseline in Ocular Hyperemia Score at Week 12 in Subjects Using Ganfort® at Baseline |
-0.1 | — |
| SECONDARY Percentage of Subjects Who Reach Target IOP of ≤ 18 mmHg in Subjects Using Ganfort® at Baseline |
78.6; 85.5 | — |
| SECONDARY Mean Change From Baseline in IOP at Week 4 in Subjects Using Ganfort® at Baseline |
20.1; -3.8 | — |
Eligibility Criteria
Inclusion Criteria
- Clinical diagnosis of ocular hypertension, open-angle or pigment dispersion glaucoma in at least one eye.
- Stable IOP-lowering regimen of bimatoprost 0.03%/timolol 0.5% therapy (either administered concomitantly or in a fixed combination) within 4 weeks prior to the screening visit.
- IOP considered to be safe (in the opinion of the investigator), in both eyes, to assure clinical stability of vision and the optic nerve throughout the study period.
- IOP between 19 to 35 mmHg (at any time of the day) in at least one eye (which would be designated as the study eye).
- Willing to discontinue the use of all other ocular hypotensive medication(s) prior to receiving the study medication for the entire course of the study.
- Able to follow instructions and willing and able to attend all study visits.
- Best corrected visual acuity of 6/60 (20/200 Snellen, 1.0 LogMAR) or better in each eye.
- Sign informed consent.
- Other protocol-defined inclusion criteria may apply.
Exclusion Criteria
- Known medical history of allergy, hypersensitivity or poor tolerance to any component of DuoTrav® that is deemed clinically significant in the opinion of the Principal Investigator.
- Corneal dystrophies in either eye.
- Risk of visual field or visual acuity worsening as a consequence of participation in the study, in the investigator's best judgment.
- Bronchial asthma or a history of bronchial asthma, bronchial hyper reactivity, or severe chronic obstructive pulmonary disease that would preclude the safe administration of a topical beta-blocker.
- History of severe allergic rhinitis.
- A condition, which in the opinion of the Principal Investigator, would interfere with optimal participation in the study, or which would present a special risk to the subject.
- Participation in any other investigational study within 30 days prior to the Screening Visit.
- Other protocol-defined exclusion criteria may apply.
Data sourced from ClinicalTrials.gov (NCT01327599). 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.