NCT06582732

Performance of the Travoprost Intraocular Implant

Prospective, Non-Randomized, Open-Label, Single Center Study to Evaluate the Performance of the Travoprost Intraocular Implant

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 210 (actual)
• Sponsor: Glaukos Corporation · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Conditions

• Glaucoma, Open-Angle
• Ocular Hypertension

Interventions

Type	Name	Description
DRUG	Travoprost Intracameral Implant exchanged at Month 12	intracameral implant containing travoprost 75 mcg implanted on Day 1 and exchanged at Month 12
DRUG	Travoprost Intracameral Implant exchanged at Month 3	intracameral implant containing travoprost 75 mcg implanted on Day 1 and exchanged at Month 3
DRUG	Travoprost Intracameral Implant exchanged at Month 6	intracameral implant containing travoprost 75 mcg implanted on Day 1 and exchanged at Month 6
DRUG	Travoprost Intracameral Implant exchanged at Month 24	intracameral implant containing travoprost 75 mcg implanted on Day 1 and exchanged at Month 24
DRUG	Travoprost intracameral implant exchanged at Month 21	intracameral implant containing travoprost 75 mcg implanted on Day 1 and exchanged at Month 21
DRUG	Travoprost intracameral implant exchanged at Month 18	intracameral implant containing travoprost 75 mcg implanted on Day 1 and exchanged at Month 18
DRUG	Travoprost intracameral implant exchanged at Month 15	intracameral implant containing travoprost 75 mcg implanted on Day 1 and exchanged at Month 15

Timeline

• Start date: 2021-03-10
• Primary completion: 2023-11-02
• Completion: 2023-11-02
• First posted: 2024-09-03
• Last updated: 2024-10-15
• Results posted: 2024-10-15

Locations

1 site across 1 country: Armenia

Regulatory

• FDA-regulated drug study