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| Sponsor: | Alcon Research |
|---|---|
| Information provided by (Responsible Party): | Alcon Research |
| ClinicalTrials.gov Identifier: | NCT00912054 |
Purpose
To demonstrate superiority of DuoTrav APS over XALACOM® in Ocular Surface Health in patients with open angle glaucoma or ocular hypertension.
| Condition | Intervention | Phase |
|---|---|---|
|
Open Angle Glaucoma Ocular Hypertension |
Drug: DuoTrav APS Drug: Xalacom |
Phase III |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| Enrollment: | 240 |
| Study Start Date: | March 2010 |
| Primary Completion Date: | June 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
DuoTrav APS
|
Drug: DuoTrav APS
travoprost APS 40 micrograms/ml / timolol 5 mg/ml, Eye Drops, Solution, once daily
|
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Active Comparator: 2
Xalacom
|
Drug: Xalacom
XALACOM® (latanoprost 50 micrograms/ml / timolol 5 mg/ml) Eye Drops, Solution
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations
More Information
| Responsible Party: | Alcon Research |
| ClinicalTrials.gov Identifier: | NCT00912054 History of Changes |
| Other Study ID Numbers: | C-09-007 |
| Study First Received: | June 1, 2009 |
| Last Updated: | January 13, 2012 |
| Health Authority: | United States: Food and Drug Administration |
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OAG OH |
|
Glaucoma Glaucoma, Open-Angle Hypertension Ocular Hypertension |
Eye Diseases Vascular Diseases Cardiovascular Diseases |