Status:
COMPLETED
Performance of the Travoprost Intraocular Implant
Lead Sponsor:
Glaukos Corporation
Conditions:
Glaucoma, Open-Angle
Ocular Hypertension
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
To evaluate the performance of the Travoprost Intracameral Implant by determining residual drug in explanted implants of the Travoprost Intracameral Implant and by determining aqueous humor concentrat...
Eligibility Criteria
Inclusion
- Diagnosis of either open angle glaucoma (i.e. primary, pseudoexfoliation, or pigmentary glaucoma) or ocular hypertenson
- Zero to three topical intraocular pressure lowering medications at the time of Visit 1 (Screening) exam.
- Best spectacle corrected visual acuity of 16 letters or more correctly read at 4 meters or better in each eye.
- Open angle as defined by Shaffer grade ≥ 3 at slit-lamp at the planned implantation site
Exclusion
- Traumatic, uveitic, neovascular, or angle-closure glaucoma; or glaucoma associated with vascular disorders
- Active ocular inflammation, infection or edema
- Clinically significant dystrophy (e.g., bullous keratopathy, Fuch's dystrophy) or clinically significant guttata
Key Trial Info
Start Date :
March 10 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 2 2023
Estimated Enrollment :
210 Patients enrolled
Trial Details
Trial ID
NCT06582732
Start Date
March 10 2021
End Date
November 2 2023
Last Update
October 15 2024
Active Locations (1)
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1
Glaukos Clinical Study Site
Yerevan, Armenia