Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
60 participants
INTERVENTIONAL
2010-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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TRAVATAN
TRAVATAN 0.004% once daily
Travoprost 0.004%
1 drop in each eye once daily for five days, and 1 drop vehicle in each eye 7 times daily for 5 days
Travoprost Vehicle
Travoprost Vehicle
Travoprost Vehicle
1 drop in each eye 8 times daily for 5 days
Travoprost Group A
Travoprost Group A
Travoprost (Groups A, B and C)
1 drop in each eye 8 times daily for 5 days
Travoprost Group B
Travoprost Group B
Travoprost (Groups A, B and C)
1 drop in each eye 8 times daily for 5 days
Travoprost Group C
Travoprost Group C
Travoprost (Groups A, B and C)
1 drop in each eye 8 times daily for 5 days
Interventions
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Travoprost 0.004%
1 drop in each eye once daily for five days, and 1 drop vehicle in each eye 7 times daily for 5 days
Travoprost Vehicle
1 drop in each eye 8 times daily for 5 days
Travoprost (Groups A, B and C)
1 drop in each eye 8 times daily for 5 days
Eligibility Criteria
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Inclusion Criteria
2. diagnosed with open-angle glaucoma, and/or ocular hypertension
3. meets the following IOP entry criteria:
* Mean IOP ≥ 24 millimeters mercury (mmHg) in at least 1 eye, with the same eye qualifying at 8 AM on both the Eligibility Visit (Day 0) and Day 1
* Mean IOP ≤ 36 mmHg in both eyes at 8 AM and 8 PM at the Eligibility Visit (Day 0), and at 8 AM on Day 1
4. satisfies all informed consent requirements; able to read, sign and date the informed consent
Exclusion Criteria
2. angle grade less than Grade 2 in either eye
3. cup to disc ratio greater than 0.8 (horizontal or vertical measurement) in either eye
4. severe central visual field loss in either eye
5. any abnormality preventing reliable applanation tonometry in either eye
6. hypersensitivity to prostaglandin analogues or to any component of the study medication
18 Years
ALL
No
Sponsors
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Alcon Research
INDUSTRY
Responsible Party
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Alcon Research, Ltd
Locations
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Contact Alcon Call Center For Trial Locations
Fort Worth, Texas, United States
Countries
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Other Identifiers
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C-09-075
Identifier Type: -
Identifier Source: org_study_id
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