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Sponsored by: |
Inspire Pharmaceuticals |
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Information provided by: | Inspire Pharmaceuticals |
ClinicalTrials.gov Identifier: | NCT00767793 |
The purpose of this study is to evaluate the safety and tolerability of INS117548 ophthalmic solution.
Condition | Intervention | Phase |
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Glaucoma |
Drug: Placebo Drug: INS117548 |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment |
Official Title: | A Multi-Center, Double-Masked, Randomized, Placebo-Controlled, Ascending Dose Study of INS117548 Ophthalmic Solution in Subjects With Bilateral Ocular Hypertension or Early Primary Open Angle Glaucoma |
Estimated Enrollment: | 60 |
Study Start Date: | September 2008 |
Estimated Study Completion Date: | July 2009 |
Estimated Primary Completion Date: | July 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Arm 1: Placebo Comparator
One drop in each eye every 12 hours for seven days
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Drug: Placebo
One drop in each eye every 12 hours for seven days
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Arm 2: Experimental
One drop of Concentration #1 in one eye and one drop of placebo in contralateral eye every 12 hours for seven days
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Drug: INS117548
One drop of Concentration #1 in one eye and one drop of placebo in contralateral eye every 12 hours for seven days
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Arm 3: Experimental
One drop of Concentration #2 in one eye and one drop of placebo in contralateral eye every 12 hours for seven days
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Drug: INS117548
One drop of Concentration #2 in one eye and one drop of placebo in contralateral eye every 12 hours for seven days
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Arm 4: Experimental
One drop of Concentration #3 in one eye and one drop of placebo in contralateral eye every 12 hours for seven days
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Drug: INS117548
One drop of Concentration #3 in one eye and one drop of placebo in contralateral eye every 12 hours for seven days
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Ages Eligible for Study: | 18 Years to 80 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, California | |
Sall Research Medical Center | |
Artesia, California, United States, 90701 | |
United States, Kentucky | |
Taustine Eye Center | |
Louisville, Kentucky, United States, 40217 | |
United States, North Carolina | |
Mundorf Eye Center | |
Charlotte, North Carolina, United States, 28204 | |
United States, Pennsylvania | |
UPMC Eye Center | |
Pittsburgh, Pennsylvania, United States, 15213 |
Study Director: | Reza Haque, MD, PhD | Medical Monitor, Inspire |
Responsible Party: | Inspire ( Mike Schiewe, Manager, Ophthalmic Clincial Research ) |
Study ID Numbers: | 037-101 |
Study First Received: | October 2, 2008 |
Last Updated: | May 7, 2009 |
ClinicalTrials.gov Identifier: | NCT00767793 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Glaucoma Eye Diseases Glaucoma, Open-Angle Hypertension Ocular Hypertension |
Glaucoma Eye Diseases Ocular Hypertension |