Travoprost Intraocular Implant + iStent Infinite vs. iStent Infinite Alone

• Status: Recruiting
• Trial end date: 2025-11-01
• Target enrollment: 0
• Participant gender: All

Summary

Adult subjects with elevated intraocular pressure who have successfully undergone placement of iStent infinite trabecular bypass system will be randomized to receive a travoprost intraocular implant or receive a sham procedure and be followed for 12 months.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Glaukos Corporation
• Treatments: Travoprost

Criteria

Inclusion Criteria:

• diagnosis of open-angle glaucoma or ocular hypertension

• qualifying IOP in the study eye

Exclusion Criteria:

• unmedicated (washed out) IOP of >36 mmHg in the study eye

• hypersensitivity to travoprost or any other components of the travoprost intraocular implant

• vertical cup/disc ratio > 0.8 in the study eye

• best spectacle corrected visual acuity of worse than 20/80 in either eye eye

• any ocular disease or condition that, in the opinion of the investigator, may put the subject at significant risk, may confound the study results, or may interfere significantly with the subject's participation in the study