Glaucoma, Open-Angle Clinical Trial
Official title:
Multicenter, Randomized, Double-masked Trial to Evaluate the Safety and Efficacy of iDose® TR (Travoprost Intraocular Implant) in Conjunction With the Placement of iStent Infinite vs. iStent Infinite Alone in Subjects With Open-angle Glaucoma or Ocular Hypertension
Adult subjects with elevated intraocular pressure who have successfully undergone placement of iStent infinite trabecular bypass system will be randomized to receive a travoprost intraocular implant or receive a sham procedure and be followed for 12 months.
Status | Recruiting |
Enrollment | 150 |
Est. completion date | November 2025 |
Est. primary completion date | February 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - diagnosis of open-angle glaucoma or ocular hypertension - qualifying IOP in the study eye Exclusion Criteria: - unmedicated (washed out) IOP of >36 mmHg in the study eye - hypersensitivity to travoprost or any other components of the travoprost intraocular implant - vertical cup/disc ratio > 0.8 in the study eye - best spectacle corrected visual acuity of worse than 20/80 in either eye eye - any ocular disease or condition that, in the opinion of the investigator, may put the subject at significant risk, may confound the study results, or may interfere significantly with the subject's participation in the study |
Country | Name | City | State |
---|---|---|---|
United States | Glaukos Clinical Study Site | Colorado Springs | Colorado |
Lead Sponsor | Collaborator |
---|---|
Glaukos Corporation |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | change from baseline in mean diurnal intraocular pressure (IOP) | mean diurnal IOP at the 3 month visit minus mean diurnal IOP at baseline | 3 months |
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