Safety and Efficacy of a Drug Delivery System in Glaucoma
NCT ID: NCT01016691
Last Updated: 2015-03-06
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
47 participants
INTERVENTIONAL
2009-10-31
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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High Dose Drug Device/ bimatoprost 0.03%
drug device containing 65 micrograms of bimatoprost released over 4 days (first period) bimatoprost 0.03% ophthalmic solution for one day (second period).
High Dose Drug Device
device inserted for 4 days
bimatoprost 0.03%
one drop in each eye on one day only
Low Dose Drug Device / bimatoprost 0.03%
drug device containing 45 micrograms of bimatoprost released over 4 days (first period) bimatoprost 0.03% ophthalmic solution for one day (second period).
Low Dose Drug Device
device inserted for 4 days
bimatoprost 0.03%
one drop in each eye on one day only
Placebo Device / bimatoprost 0.03%
placebo drug device worn over 4 days (first period) bimatoprost 0.03% ophthalmic solution for one day (second period).
Placebo Device
device inserted for 4 days
bimatoprost 0.03%
one drop in each eye on one day only
Interventions
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High Dose Drug Device
device inserted for 4 days
Low Dose Drug Device
device inserted for 4 days
Placebo Device
device inserted for 4 days
bimatoprost 0.03%
one drop in each eye on one day only
Eligibility Criteria
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Inclusion Criteria
* Open angle glaucoma or ocular hypertension
* Corrected visual acuity in each eye of 20/200 or better
Exclusion Criteria
* Planned contact lens use during the study
* Clinically significant ocular or systemic disease that might interfere with the study
* Use of chronic corticosteroids by any route
21 Years
ALL
No
Sponsors
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Vistakon Pharmaceuticals
INDUSTRY
Responsible Party
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Locations
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Miami, Florida, United States
Philadelphia, Pennsylvania, United States
Mt. Pleasant, South Carolina, United States
Rapid City, South Dakota, United States
Maryville, Tennessee, United States
Countries
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Other Identifiers
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CR-1649
Identifier Type: -
Identifier Source: org_study_id
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