Safety and Efficacy of iDose® TR With Cataract Surgery vs. Cataract Surgery Alone

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

RECRUITING

Clinical Phase

PHASE4

Total Enrollment

132 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-01-13

Study Completion Date

2027-06-30

Brief Summary

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This trial will evaluate the safety and IOP -lowering efficacy of administering an iDose TR (travoprost intracameral implant) in conjunction with cataract surgery compared to cataract surgery alone

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Detailed Description

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This is a Phase 4 randomized, double-masked, parallel group trial designed to evaluate the safety and IOP-lowering efficacy of administering iDose TR (travoprost intracameral implant 75 mcg) in conjunction with uncomplicated cataract surgery (phacoemulsification with a posterior chamber intraocular lens) compared to uncomplicated cataract surgery alone, in patients with open-angle glaucoma (OAG) or ocular hypertension (OHT).

Conditions

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Glaucoma, Open-angle Ocular Hypertension (OHT) Phacoemulsification Cataract Surgery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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iDose TR (travoprost intracameral implant) 75 µg in conjunction with cataract surgery

Group Type ACTIVE_COMPARATOR

iDose TR (travoprost intracameral implant) 75 µg in conjunction with cataract surgery

Intervention Type COMBINATION_PRODUCT

iDose TR (travoprost intracameral implant) 75 µg in conjunction with cataract surgery

Sham procedure in conjunction with cataract surgery

Group Type SHAM_COMPARATOR

Sham procedure in conjunction with cataract surgery

Intervention Type PROCEDURE

Sham procedure in conjunction with cataract surgery

Interventions

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iDose TR (travoprost intracameral implant) 75 µg in conjunction with cataract surgery

Intervention Type COMBINATION_PRODUCT

Sham procedure in conjunction with cataract surgery

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Cataract diagnosis: clinically significant age-related cataract eligible for phacoemulsification in the study eye.
* OAG or OHT diagnosis: either OAG (i.e. primary, pseudoexfoliation, or pigmentary glaucoma) or OHT in the study eye (i.e., eye to undergo cataract surgery)