Status:
COMPLETED
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
Lead Sponsor:
Glaukos Corporation
Conditions:
Open-angle Glaucoma
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
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 oc...
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 oc...
Eligibility Criteria
Inclusion
- Phakic study eye
- IOP ≥ 21 mmHg and ≤ 40 mmHg at the screening visit (subjects with OHT require a second screening IOP measurement
Exclusion
- Aphakic or pseudophakic eyes (AC-IOLs or PC-IOLs)
- Previous usage of topical prostaglandin analogues or prior medical therapy for glaucoma
Key Trial Info
Start Date :
September 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 28 2019
Estimated Enrollment :
196 Patients enrolled
Trial Details
Trial ID
NCT01444040
Start Date
September 1 2011
End Date
March 28 2019
Last Update
September 8 2022
Active Locations (1)
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1
S.V. Malayan Ophthalmological Center
Yerevan, Armenia, 0001