Travoprost Intraocular Implant in Conjunction With Cataract Surgery

Glaukos

Status and phase

Active, not recruiting

Phase 3

Conditions

Open Angle Glaucoma

Ocular Hypertension

Treatments

Drug: iDose TR

Study type

Interventional

Funder types

Industry

Identifiers

NCT06061718

GLK-101-02

Details and patient eligibility

About

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.

Enrollment

60 patients

Sex

All

Ages

45+ years old

Volunteers

No 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