Travoprost Intraocular Implant in Conjunction With Cataract Surgery

Phase 3

Active, not recruiting

• Conditions: Ocular Hypertension; Open Angle Glaucoma
• Interventions: Drug: iDose TR

• Registration Number: NCT06061718
• Lead Sponsor: Glaukos Corporation

Brief Summary

Subjects with cataract requiring extraction and who have open-angle glaucoma or ocular hypertension will undergo screening and washout from IOP-lowering medication, if applicable. Eligible subjects who meet all inclusion criteria and none of the exclusion criteria and who undergo successful cataract extraction with implantation of a posterior chamber intraocular lens (PC-IOL) will receive a travoprost intraocular implant and followed up for 12 months.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-09-11
• Study First Submitted: 2023-09-25
• Study First Submitted QC: 2023-09-25
• Study First Posted: 2023-09-29
• Primary Completion: 2024-03-18
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-30
• Last Update Posted: 2024-06-03
• Study Completion: 2024-12-20

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• clinically significant age-related cataract eligible for phacoemulsification in the study eye
• open-angle glaucoma or ocular hypertension in the study eye
• successful, uncomplicated cataract surgery using small incision phacoemulsification cataract surgery and insertion of a foldable posterior chamber IOL

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 the fellow 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
iDose TR	iDose TR	Travoprost Intraocular Implant administered intracamerally in the study eye at the Day 1 Visit following successful cataract surgery

Primary Outcome Measures

Name	Time	Method
Change from baseline in mean diurnal IOP	3 months	Mean diurnal IOP at the Month 3 Visit minus the mean diurnal IOP at the Baseline Visit

Trial Locations

Locations (1)

Glaukos Clinical Study Site; 🇦🇲 Yerevan, Armenia