Performance of the Travoprost Intraocular Implant
NCT Number: NCT06582732
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Glaucoma, Open-Angle|Ocular Hypertension
Interventions: DRUG: Travoprost Intracameral Implant exchanged at Month 12|DRUG: Travoprost Intracameral Implant exchanged at Month 3|DRUG: Travoprost Intracameral Implant exchanged at Month 6|DRUG: Travoprost Intracameral Implant exchanged at Month 24|DRUG: Travoprost intracameral implant exchanged at Month 21|DRUG: Travoprost intracameral implant exchanged at Month 18|DRUG: Travoprost intracameral implant exchanged at Month 15
Sponsor: Glaukos Corporation
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 210
Study Design: Allocation: NON_RANDOMIZED|Intervention Model: SEQUENTIAL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2021-03-10
Completion Date: 2023-11-02
Locations: Glaukos Clinical Study Site, Yerevan, Armenia

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

Primary Outcome Measures: Travoprost free acid concentration (ng/mL) in aqueous humor 12 months post-administration, 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), month 12|Travoprost free acid concentration (ng/mL) in aqueous humor 3 months post-administration, concentration of travoprost free acid (ng/mL) in the aqueous humor 3 months post-administration as assessed by LC-MS/MS, month 3|Travoprost free acid concentration (ng/mL) in aqueous humor 6 months post-administration, concentration of travoprost free acid (ng/mL) in the aqueous humor 6 months post-administration as assessed by LC-MS/MS, month 6|Travoprost free acid concentration (ng/mL) in aqueous humor 24 months post-administration, concentration of travoprost free acid (ng/mL) in the aqueous humor 24 months post-administration as assessed by LC-MS/MS, month 24|Travoprost free acid concentration(ng/mL) in aqueous humor 21 months post-administration, concentration of travoprost free acid (ng/mL) in the aqueous humor 21 months post-administration as assessed by LC-MS/MS, month 21|Travoprost free acid concentration (ng/mL) in aqueous humor 18 months post-administration, concentration of travoprost free acid (ng/mL) in the aqueous humor 18 months post-administration as assessed by LC-MS/MS, month 18|Travoprost free acid concentration (ng/mL) in aqueous humor 15 months post-administration, concentration of travoprost free acid (ng/mL) in the aqueous humor 15 months post-administration as assessed by LC-MS/MS, month 15
Secondary Outcome Measures: percent residual travoprost in explanted implant 12 months post-administration, percent of travoprost compared to baseline in explanted implant 12 months post-administration as assessed by high performance liquid chromatography (HPLC), month 12|percent residual travoprost in explanted implant 3 months post-administration, percent of travoprost compared to baseline in explanted implant 3 months post-administration as assessed by HPLC, month 3|percent residual travoprost in explanted implant 6 months post-administration, percent of travoprost compared to baseline in explanted implant 6 months post-administration as assessed by HPLC, month 6|percent residual travoprost in explanted implant 24 months post-administration, percent of travoprost compared to baseline in explanted implant 24 months post-administration as assessed by HPLC, month 24|percent residual travoprost in explanted implant 21 months post-administration, percent of travoprost compared to baseline in explanted implant 21 months post-administration as assessed by HPLC, month 21|percent residual travoprost in explanted implant 18 months post-administration, percent of travoprost compared to baseline in explanted implant 18 months post-administration as assessed by HPLC, month 18|percent residual travoprost in explanted implant 15 months post-administration, percent of travoprost compared to baseline in explanted implant 15 months post-administration as assessed by HPLC, month 15