Global DuoTrav® Study
| Status: | Completed |
|---|---|
| Conditions: | High Blood Pressure (Hypertension), Ocular |
| Therapuetic Areas: | Cardiology / Vascular Diseases, Ophthalmology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/21/2016 |
| Start Date: | December 2013 |
| End Date: | May 2015 |
Prospective, Randomized, Multi-Center Study to Evaluate the Efficacy and Tolerability of DuoTrav® in Patients Previously Uncontrolled on a Beta-blocker
The purpose of this study is to demonstrate superior intraocular pressure (IOP) control with
travoprost 0.004% / timolol 0.5% (DuoTrav®) compared to beta-blocker monotherapy in patients
with open-angle glaucoma or ocular hypertension.
travoprost 0.004% / timolol 0.5% (DuoTrav®) compared to beta-blocker monotherapy in patients
with open-angle glaucoma or ocular hypertension.
Inclusion Criteria:
- Have a clinical diagnosis of either open angle glaucoma or ocular hypertension.
- Currently on beta-blocker monotherapy (for >30 days) and would benefit, in the
opinion of the investigator, from further lOP reduction.
- Have a mean baseline lOP of >18 mmHg and <32 mmHg in at least one eye.
- Must be able to understand and sign an Informed Consent form.
- Other protocol-specified inclusion criteria may apply.
Exclusion Criteria:
- Severe central visual field loss in either eye within the last year.
- Chronic, recurrent or severe inflammatory eye disease (e.g., sclerotic, uveitis, or
herpes keratitis).
- Ocular trauma or surgery within the past 6 months.
- Ocular infection or ocular inflammation within the past 3 months.
- Best-corrected visual acuity (BCVA) score worse than 55 ETDRS letters (equivalent to
20/80 Snellen, 0.60 logMAR or 0.25 decimal).
- Any abnormality preventing reliable measurement of IOP.
- Other ocular pathology (including severe dry eye) that may, in the opinion of the
investigator, preclude the administration of study medication.
- Condition that requires the use of any additional topical or systemic ocular
hypotensive medication during the study.
- Hypersensitivity to prostaglandin analogues or any component of the study medications
in the opinion of the investigator.
- Asthma, history of asthma, or severe chronic obstructive pulmonary disease.
- Condition that does not allow the patient to discontinue all glucocorticoids
administered by any route safely.
- Therapy with another investigational agent within 30 days prior to Visit 1.
- Any other condition including severe illness which would make the patient, in the
opinion of the investigator, unsuitable for the study.
- Women of childbearing potential if pregnant, test positive for pregnancy at Screening
visit, breastfeeding, or not in agreement to use adequate birth control methods to
prevent pregnancy throughout the study.
- Other protocol-specified exclusion criteria may apply.
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