- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01444040
Subjects With Open-angle Glaucoma, Pseudoexfoliative Glaucoma, or Ocular Hypertension Naïve to Medical and Surgical Therapy, Treated With Two Trabecular Micro-bypass Stents (iStent Inject) or Travoprost
September 2, 2022 updated by: Glaukos Corporation
A Prospective, Randomized Evaluation of Subjects With Open-angle Glaucoma, Pseudoexfoliative Glaucoma, or Ocular Hypertension Naïve to Medical and Surgical Therapy, Treated With Two Trabecular Micro-bypass Stents (iStent Inject) or Travoprost Ophthalmic Solution 0.004%
Evaluation of the intraocular pressure (IOP) lowering effect of two iStent inject devices versus medical therapy in eyes of subjects with primary open-angle glaucoma, pseudoexfoliative glaucoma, or ocular hypertension naïve to medical and surgical therapy.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Evaluation of the intraocular pressure (IOP) lowering effect of two iStent inject devices versus medical therapy in eyes of subjects with primary open-angle glaucoma, pseudoexfoliative glaucoma, or ocular hypertension naïve to medical and surgical therapy.
Study Type
Interventional
Enrollment (Actual)
196
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Yerevan, Armenia, 0001
- S.V. Malayan Ophthalmological Center
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Phakic study eye
- IOP ≥ 21 mmHg and ≤ 40 mmHg at the screening visit (subjects with OHT require a second screening IOP measurement
Exclusion Criteria:
- Aphakic or pseudophakic eyes (AC-IOLs or PC-IOLs)
- Previous usage of topical prostaglandin analogues or prior medical therapy for glaucoma
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: iStent inject
Implantation of two iStent inject devices
|
Implantation of two iStent inject devices
|
Active Comparator: Drug
Travoprost drops
|
Travoprost drops
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change from screening in mean diurnal IOP (mm Hg) at the Month 12 visit.
Time Frame: 12 months
|
12 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in mean diurnal IOP vs. screening
Time Frame: Month 24
|
Month 24
|
|
Change in screening in time-wise IOPs
Time Frame: Various Month 12-60
|
Various Month 12-60
|
|
Proportion of responders
Time Frame: Various 12-60 months
|
A responder is defined as a subject with a certain target IOP value or a certain reduction of IOP as compared to screening.
In the iStent inject group, a responder must not be on an ocular hypotensive medications or have had a postoperative procedure to reposition or remove stent(s) prior to the visit.
Due to the lack of a complete consensus on the definition of a clinical responder, a set of target IOP values (e.g., downwards from 22 mm Hg in steps of 1 mm Hg) and reductions of IOP (e.g., downwards from the highest reduction in IOP in steps of 5%) will be evaluated.
|
Various 12-60 months
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Adverse event reporting
Time Frame: 0-60 months
|
Rate of ocular adverse events through 60 months
|
0-60 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 1, 2011
Primary Completion (Actual)
March 28, 2019
Study Completion (Actual)
March 28, 2019
Study Registration Dates
First Submitted
September 28, 2011
First Submitted That Met QC Criteria
September 29, 2011
First Posted (Estimate)
September 30, 2011
Study Record Updates
Last Update Posted (Actual)
September 8, 2022
Last Update Submitted That Met QC Criteria
September 2, 2022
Last Verified
September 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- GCF-027
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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