Safety and Effects of Brimonidine Intravitreal Implant in Patients With Glaucomatous Optic Neuropathy
NCT ID: NCT00693485
Last Updated: 2013-04-24
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
70 participants
INTERVENTIONAL
2008-09-30
2011-08-31
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
TRIPLE
Study Groups
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400 ug Brimonidine Implant
400 ug Brimonidine Tartrate Posterior Segment Drug Delivery system; Applicator System at Day 1 in study eye.
400 ug Brimonidine Implant
400 ug Brimonidine Tartrate Posterior Segment Drug Delivery system; Applicator System at Day 1 in study eye.
200 ug Brimonidine Implant
200 ug Brimonidine Tartrate Posterior Segment Drug Delivery system; Applicator System at Day 1 in study eye.
200 ug Brimonidine Implant
200 ug Brimonidine Tartrate Posterior Segment Drug Delivery system; Applicator System at Day 1 in study eye.
Sham (no implant)
Sham Posterior Segment Drug Delivery system; Applicator System at Day 1 in study eye.
Sham (no implant)
Sham Posterior Segment Drug Delivery system; Applicator System at Day 1 in study eye.
Interventions
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400 ug Brimonidine Implant
400 ug Brimonidine Tartrate Posterior Segment Drug Delivery system; Applicator System at Day 1 in study eye.
200 ug Brimonidine Implant
200 ug Brimonidine Tartrate Posterior Segment Drug Delivery system; Applicator System at Day 1 in study eye.
Sham (no implant)
Sham Posterior Segment Drug Delivery system; Applicator System at Day 1 in study eye.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Visual acuity 20/80 or better
* Intraocular pressure in the study eye ≤ 24 mm Hg
* Glaucomatous visual field loss - 7 dB to - 25 dB
Exclusion Criteria
* Uncontrolled systemic disease or infection of the eye
* Recent eye surgery or injections in the eye
* Female patients who are pregnant, nursing or planning a pregnancy
18 Years
ALL
No
Sponsors
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Allergan
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Director
Role: STUDY_DIRECTOR
Allergan
Locations
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Artesia, California, United States
Tel Aviv, , Israel
Countries
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Other Identifiers
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190342-030D
Identifier Type: -
Identifier Source: org_study_id
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