Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
33 participants
INTERVENTIONAL
2020-11-19
2022-02-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Implantation and Exchange
Subjects will undergo implantation and exchange of a Travoprost Intraocular Implant through a small temporal clear corneal incision.
Travoprost
Implantation and exchange of a Travoprost Intraocular Implant through a clear corneal incision
Interventions
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Travoprost
Implantation and exchange of a Travoprost Intraocular Implant through a clear corneal incision
Eligibility Criteria
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Inclusion Criteria
* Able and willing to provide written informed consent on the IRB (institutional review board)/IEC (institutional ethics committee)-approved Informed Consent form
* Best spectacle corrected visual acuity of 20/80 or better in each eye.
* Previously qualified for GC-009 clinical trial using the Travoprost Intraocular Implant with the travoprost intraocular implant (G2TR) that is present in the study eye.
Exclusion Criteria
* Traumatic, uveitic, neovascular, or angle-closure glaucoma; or glaucoma associated with vascular disorders
* Corneal status as follows:
* Any active inflammation or edema
* Any pathology for which, in the investigator's judgement, the following would be either at risk or contraindicated:
* Implantation of Travoprost Intraocular Implant
* Compliance to elements of the study protocol (e.g., ophthalmic examinations, follow-up visits)
* Fellow eye status as follows:
* Fellow eye actively enrolled in this trial or any other clinical trial
* Subject status as follows:
* Pregnant or planning to become pregnant during the course of the study
18 Years
ALL
No
Sponsors
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Glaukos Corporation
INDUSTRY
Responsible Party
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Locations
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Inland Eye Specialists
Hemet, California, United States
North Bath Eye Associates, Inc.
Petaluma, California, United States
Eye Center of northern Colorado, PC
Fort Collins, Colorado, United States
The Eye Associates of Manatee
Manatee, Florida, United States
Ocala Eye
Ocala, Florida, United States
Center for Sight
Sarasota, Florida, United States
Jones Eye Clinic
Sioux City, Iowa, United States
D'Ambrosio Eye Care
Lancaster, Massachusetts, United States
Northern New Jersey Eye Institute
South Orange, New Jersey, United States
Oklahoma Eye Surgeons
Oklahoma City, Oklahoma, United States
Vance Thompson Vision
Sioux Falls, South Dakota, United States
Texan Eye
Austin, Texas, United States
Lehmann Eye Center
Nacogdoches, Texas, United States
Asian Eye Institute
Makati City, , Philippines
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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IDOS-106-EXCH
Identifier Type: -
Identifier Source: org_study_id
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