Bimatoprost Ocular Insert Compared to Topical Timolol Solution in Patients With Glaucoma or Ocular Hypertension
NCT ID: NCT01915940
Last Updated: 2018-04-20
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
169 participants
INTERVENTIONAL
2013-10-23
2014-11-14
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
TRIPLE
Study Groups
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13 mg Bimatoprost Ocular Insert
Washout and placebo ocular insert in each eye for at least 4 weeks, followed by 13 mg Bimatoprost Ocular Insert in each eye and placebo eye drops twice a day in each eye for 6 months.
Bimatoprost
Bimatoprost ocular insert
Placebo Eye Drops
Placebo topical eye drops
Placebo Ocular Insert
Ocular insert without any active drug
Timolol 0.5% + Placebo Ocular Insert
Washout and placebo ocular insert in each eye for at least 4 weeks, followed by Timolol (timoptic ophthalmic solution 0.5%) twice a day in each eye plus placebo ocular insert for 6 months.
Timolol 0.5%
Timolol 0.5% solution
Placebo Ocular Insert
Ocular insert without any active drug
Interventions
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Bimatoprost
Bimatoprost ocular insert
Timolol 0.5%
Timolol 0.5% solution
Placebo Eye Drops
Placebo topical eye drops
Placebo Ocular Insert
Ocular insert without any active drug
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Primary open-angle glaucoma or ocular hypertension in both eyes
* Best-corrected distance vision of 20/80 or better
* Stable visual field
* corneal thickness between 490-620 micrometers
Exclusion Criteria
* significant risk of angle closure due to pupil dilation, defined as a Shaffer classification of less than grade 2 based on gonioscopy
* laser surgery for glaucoma/ocular hypertension on one or both eyes within the last 12 months
* past history of corneal refractive surgery
* past history of any incisional surgery for glaucoma at any time
* corneal abnormalities that would interfere with tonometry readings
* current participation in an investigational drug or device study or participation in such a study within 30 days of screening
* Inability to accurately evaluate the retina
18 Years
ALL
No
Sponsors
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ForSight Vision5, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Michelle Chen, PhD
Role: STUDY_DIRECTOR
Allergan
Locations
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Sall Medical Research Center
Artesia, California, United States
Scripps Clinic Torrey Pines
La Jolla, California, United States
Eye Research Foundation
Newport Beach, California, United States
UC Davis Dept of Ophthalmology & Vision Science
Sacramento, California, United States
Coastal Research Associates
Atlanta, Georgia, United States
Clayton Eye Center
Morrow, Georgia, United States
Ophthalmology Consultants
St Louis, Missouri, United States
UNC Kittner Eye Center
Chapel Hill, North Carolina, United States
Apex Eye
Madeira, Ohio, United States
Ophthalmology Associates PC
Fort Worth, Texas, United States
Countries
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References
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Belamkar A, Harris A, Zukerman R, Siesky B, Oddone F, Verticchio Vercellin A, Ciulla TA. Sustained release glaucoma therapies: Novel modalities for overcoming key treatment barriers associated with topical medications. Ann Med. 2022 Dec;54(1):343-358. doi: 10.1080/07853890.2021.1955146.
Other Identifiers
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FSV5-002
Identifier Type: -
Identifier Source: org_study_id
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