Performance of the Travoprost Intraocular Implant
- Conditions
- Glaucoma, Open-AngleOcular Hypertension
- Interventions
- Registration Number
- NCT06582732
- Lead Sponsor
- Glaukos Corporation
- 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 concentrations of travoprost free acid at specified timepoints post administration through 24 months
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 210
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Cohort 7 (15-month exchange) Travoprost intracameral implant exchanged at Month 15 Travoprost Intracameral Implant Exchanged at Month 15 Cohort 3 (6-month exchange) Travoprost Intracameral Implant exchanged at Month 6 Travoprost Intracameral Implant Exchanged at Month 6 Cohort 5 (21-month exchange) Travoprost intracameral implant exchanged at Month 21 Travoprost Intracameral Implant Exchanged at Month 21 Cohort 1 (12-month exchange) Travoprost Intracameral Implant exchanged at Month 12 Travoprost Intracameral Implant Exchanged at Month 12 Cohort 2 (3-month exchange) Travoprost Intracameral Implant exchanged at Month 3 Travoprost Intracameral Implant Exchanged at Month 3 Cohort 4 (24-month exchange) Travoprost Intracameral Implant exchanged at Month 24 Travoprost Intracameral Implant Exchanged at Month 24 Cohort 6 (18-month exchange) Travoprost intracameral implant exchanged at Month 18 Travoprost Intracameral Implant Exchanged at Month 18
- Primary Outcome Measures
Name Time Method Travoprost Free Acid Concentration (ng/mL) in Aqueous Humor 12 Months Post-administration month 12 concentration of travoprost free acid (ng/mL) in the aqueous humor 12 months post-administration as assessed by liquid chromatography tandem mass spectrometry (LC-MS/MS)
Travoprost Free Acid Concentration (ng/mL) in Aqueous Humor 3 Months Post-administration month 3 concentration of travoprost free acid (ng/mL) in the aqueous humor 3 months post-administration as assessed by LC-MS/MS
Travoprost Free Acid Concentration (ng/mL) in Aqueous Humor 6 Months Post-administration month 6 concentration of travoprost free acid (ng/mL) in the aqueous humor 6 months post-administration as assessed by LC-MS/MS
Travoprost Free Acid Concentration (ng/mL) in Aqueous Humor 24 Months Post-administration month 24 concentration of travoprost free acid (ng/mL) in the aqueous humor 24 months post-administration as assessed by LC-MS/MS
Travoprost Free Acid Concentration(ng/mL) in Aqueous Humor 21 Months Post-administration month 21 concentration of travoprost free acid (ng/mL) in the aqueous humor 21 months post-administration as assessed by LC-MS/MS
Travoprost Free Acid Concentration (ng/mL) in Aqueous Humor 18 Months Post-administration month 18 concentration of travoprost free acid (ng/mL) in the aqueous humor 18 months post-administration as assessed by LC-MS/MS
Travoprost Free Acid Concentration (ng/mL) in Aqueous Humor 15 Months Post-administration month 15 concentration of travoprost free acid (ng/mL) in the aqueous humor 15 months post-administration as assessed by LC-MS/MS
- Secondary Outcome Measures
Name Time Method Percent Residual Travoprost in Explanted Implant 12 Months Post-administration month 12 percent of travoprost compared to baseline in explanted implant 12 months post-administration as assessed by high performance liquid chromatography (HPLC)
Percent Residual Travoprost in Explanted Implant 3 Months Post-administration month 3 percent of travoprost compared to baseline in explanted implant 3 months post-administration as assessed by HPLC
Percent Residual Travoprost in Explanted Implant 6 Months Post-administration month 6 percent of travoprost compared to baseline in explanted implant 6 months post-administration as assessed by HPLC
Percent Residual Travoprost in Explanted Implant 24 Months Post-administration month 24 percent of travoprost compared to baseline in explanted implant 24 months post-administration as assessed by HPLC
Percent Residual Travoprost in Explanted Implant 21 Months Post-administration month 21 percent of travoprost compared to baseline in explanted implant 21 months post-administration as assessed by HPLC
Percent Residual Travoprost in Explanted Implant 18 Months Post-administration month 18 percent of travoprost compared to baseline in explanted implant 18 months post-administration as assessed by HPLC
Percent Residual Travoprost in Explanted Implant 15 Months Post-administration month 15 percent of travoprost compared to baseline in explanted implant 15 months post-administration as assessed by HPLC
Trial Locations
- Locations (1)
Glaukos Clinical Study Site
🇦🇲Yerevan, Armenia
Glaukos Clinical Study Site🇦🇲Yerevan, Armenia