Travoprost Intraocular Implant in Conjunction With Cataract Surgery

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE3

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-09-11

Study Completion Date

2024-12-20

Brief Summary

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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.

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Detailed Description

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Conditions

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Open Angle Glaucoma Ocular Hypertension

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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iDose TR

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

Group Type EXPERIMENTAL

iDose TR

Intervention Type DRUG

anchored intracameral implant containing travoprost

Interventions

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iDose TR

anchored intracameral implant containing travoprost

Intervention Type DRUG

Other Intervention Names

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travoprost intraocular implant

Eligibility Criteria

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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

Minimum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No