Status:
ACTIVE_NOT_RECRUITING
Travoprost Intraocular Implant in Conjunction With Cataract Surgery
Lead Sponsor:
Glaukos Corporation
Conditions:
Open Angle Glaucoma
Ocular Hypertension
Eligibility:
All Genders
45+ years
Phase:
PHASE3
Brief Summary
Subjects with cataract requiring extraction and who have open-angle glaucoma or ocular hypertension will undergo screening and washout from IOP-lowering medication, if applicable. Eligible subjects wh...
Eligibility Criteria
Inclusion
- clinically significant age-related cataract eligible for phacoemulsification in the study eye
- open-angle glaucoma or ocular hypertension in the study eye
- successful, uncomplicated cataract surgery using small incision phacoemulsification cataract surgery and insertion of a foldable posterior chamber IOL
Exclusion
- 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 the fellow 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
Key Trial Info
Start Date :
September 11 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 20 2024
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT06061718
Start Date
September 11 2023
End Date
December 20 2024
Last Update
June 3 2024
Active Locations (1)
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1
Glaukos Clinical Study Site
Yerevan, Armenia