A Prospective Evaluation of Open-Angle Glaucoma Subjects on Two Topical Hypotensive Medications Treated With One Suprachoroidal Stent
This study is currently recruiting participants.
Verified March 2013 by Glaukos Corporation
Sponsor:
Glaukos Corporation
Information provided by (Responsible Party):
Glaukos Corporation
ClinicalTrials.gov Identifier:
NCT01252914
First received: December 1, 2010
Last updated: March 28, 2013
Last verified: March 2013
| Tracking Information | |||||
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| First Received Date ICMJE | December 1, 2010 | ||||
| Last Updated Date | March 28, 2013 | ||||
| Start Date ICMJE | December 2010 | ||||
| Estimated Primary Completion Date | June 2017 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Mean diurnal IOP reduction of greater than or equal to 20% at month 12 vs. baseline [ Time Frame: 12 months ] [ Designated as safety issue: Yes ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT01252914 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
Mean diurnal IOP < 18 mmHg at month 12 [ Time Frame: 12 months ] [ Designated as safety issue: Yes ] | ||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Outcome Measures ICMJE |
Safety [ Time Frame: 0-61 months ] [ Designated as safety issue: Yes ] Rate of ocular adverse events through 61 months
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| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | A Prospective Evaluation of Open-Angle Glaucoma Subjects on Two Topical Hypotensive Medications Treated With One Suprachoroidal Stent | ||||
| Official Title ICMJE | A Prospective Evaluation of Open-angle Glaucoma Subjects on Two Topical Hypotensive Medication Treated With One Suprachoroidal Stent | ||||
| Brief Summary | The purpose of this study is to assess the efficacy and safety of one iStent supra stent in the reduction of intraocular pressure associated with primary open-angle glaucoma. |
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| Detailed Description | The study assesses the efficacy and safety of one iStent supra stent in the reduction of intraocular pressure associated with primary open-angle glaucoma. |
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| Study Type ICMJE | Interventional | ||||
| Study Phase | Phase 4 | ||||
| Study Design ICMJE | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
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| Condition ICMJE | Subject With Primary Open-angle Glaucoma (POAG) | ||||
| Intervention ICMJE | Device: iStent Supra Stent
Implantation of one iStent Supra Stent through a small temporal clear corneal incision |
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| Study Arm (s) | Experimental: One iStent Supra Stent and medication
The study assesses the efficacy and safety of one iStent Supra stent in the reduction of intraocular pressure associated with primary open-angle glaucoma
Intervention: Device: iStent Supra Stent |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Recruiting | ||||
| Estimated Enrollment ICMJE | 80 | ||||
| Estimated Completion Date | December 2017 | ||||
| Estimated Primary Completion Date | June 2017 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts ICMJE |
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| Location Countries ICMJE | Armenia | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01252914 | ||||
| Other Study ID Numbers ICMJE | GCF-019 | ||||
| Has Data Monitoring Committee | Not Provided | ||||
| Responsible Party | Glaukos Corporation | ||||
| Study Sponsor ICMJE | Glaukos Corporation | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE | Not Provided | ||||
| Information Provided By | Glaukos Corporation | ||||
| Verification Date | March 2013 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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