Multicenter, Randomized, Double-masked, Parallel Group Trial to Evaluate the Safety and Efficacy of iDose® TR (Travoprost Intracameral Implant) in Conjunction With Cataract Surgery vs. Cataract Surgery Alone
Status: Recruiting
Location: See location...
Intervention Type: Combination product, Procedure
Study Type: Interventional
Study Phase: Phase 4
SUMMARY
This trial will evaluate the safety and IOP -lowering efficacy of administering an iDose TR (travoprost intracameral implant) in conjunction with cataract surgery compared to cataract surgery alone
Eligibility
Participation Requirements
Sex: All
Minimum Age: 45
Healthy Volunteers: f
View:
• Cataract diagnosis: clinically significant age-related cataract eligible for phacoemulsification in the study eye.
• OAG or OHT diagnosis: either OAG (i.e. primary, pseudoexfoliation, or pigmentary glaucoma) or OHT in the study eye (i.e., eye to undergo cataract surgery)
Locations
United States
Wisconsin
Glaukos Investigator Site
RECRUITING
Kenosha
Contact Information
Primary
Study Director
ClinicalResearch@glaukos.com
949-739-8749
Time Frame
Start Date: 2025-01-13
Estimated Completion Date: 2026-09
Participants
Target number of participants: 132
Treatments
Active_comparator: iDose TR (travoprost intracameral implant) 75 µg in conjunction with cataract surgery
iDose TR (travoprost intracameral implant) 75 µg in conjunction with cataract surgery
Sham_comparator: Sham procedure in conjunction with cataract surgery
Sham procedure in conjunction with cataract surgery
Related Therapeutic Areas
Sponsors
Leads: Glaukos Corporation