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Sponsored by: |
Alcon Research |
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Information provided by: | Alcon Research |
ClinicalTrials.gov Identifier: | NCT00848536 |
A Multi-Center Double-masked Study of the Safety and Efficacy of Travoprost APS Compared to TRAVATAN in Patients with Open-angle Glaucoma or Ocular Hypetersion
Condition | Intervention | Phase |
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Open Angle Glaucoma Ocular Hypertension |
Drug: Travoprost APS Drug: TRAVATAN |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment |
Estimated Enrollment: | 330 |
Study Start Date: | March 2009 |
Estimated Primary Completion Date: | March 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
Travoprost APS
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Drug: Travoprost APS
Eye Drops, Solution, once daily
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2: Active Comparator
TRAVATAN
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Drug: TRAVATAN
Eye Drops, Solution, once daily
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
All patients: Mean IOP in same eye (at both Eligibility 1 & 2 Visits)
Exclusion Criteria:
Responsible Party: | Alcon Research Ltd ( Miguel Martinez, M.D., Ph.D./Global Study Manager ) |
Study ID Numbers: | C-08-40, Eudract number: 2008-006027-31 |
Study First Received: | February 19, 2009 |
Last Updated: | February 19, 2009 |
ClinicalTrials.gov Identifier: | NCT00848536 History of Changes |
Health Authority: | United States: Food and Drug Administration |
OAG OHT |
Glaucoma Eye Diseases Glaucoma, Open-Angle Vascular Diseases Cardiovascular Agents |
Tetrahydrozoline Antihypertensive Agents Travoprost Hypertension Ocular Hypertension |
Glaucoma Therapeutic Uses Eye Diseases Glaucoma, Open-Angle Vascular Diseases Cardiovascular Diseases |
Cardiovascular Agents Antihypertensive Agents Pharmacologic Actions Travoprost Ocular Hypertension Hypertension |