Travoprost Intraocular Implant in Conjunction With Cataract Surgery

Sponsor

Glaukos Corporation (Industry)

Overall Status

Recruiting

CT.gov ID

NCT06061718

Collaborator

(none)

Enrollment

Location

Arm

21.7

Anticipated Duration (Months)

2.8

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Open Angle Glaucoma Ocular Hypertension	Drug: iDose TR	Phase 3

Study Design

Study Type:

Interventional

Anticipated Enrollment :

60 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Multicenter, Open-label, Single-arm Trial to Evaluate the Safety and Efficacy of iDose® TR (Travoprost Intraocular Implant) in Conjunction With Cataract Surgery

Actual Study Start Date :

Sep 11, 2023

Anticipated Primary Completion Date :

Sep 1, 2024

Anticipated Study Completion Date :

Jul 1, 2025

Arms and Interventions

Arm	Intervention/Treatment
Experimental: iDose TR Travoprost Intraocular Implant administered intracamerally in the study eye at the Day 1 Visit following successful cataract surgery	Drug: iDose TR anchored intracameral implant containing travoprost Other Names: travoprost intraocular implant

Arm

Intervention/Treatment

Experimental: iDose TR

Travoprost Intraocular Implant administered intracamerally in the study eye at the Day 1 Visit following successful cataract surgery

Drug: iDose TR

anchored intracameral implant containing travoprost

Other Names:

travoprost intraocular implant

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

45 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Glaukos Clinical Study Site	Yerevan		Armenia

Sponsors and Collaborators

Glaukos Corporation

Investigators

Study Director: Study Director, Glaukos Corporation

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Glaukos Corporation

ClinicalTrials.gov Identifier:

NCT06061718

Other Study ID Numbers:

GLK-101-02

First Posted:

Sep 29, 2023

Last Update Posted:

Sep 29, 2023

Last Verified:

Sep 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Yes

Additional relevant MeSH terms:

Study Results

No Results Posted as of Sep 29, 2023