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

Glaukos

Status and phase: Enrolling; Phase 4

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

Treatments: Procedure: Sham procedure in conjunction with cataract surgery; Combination Product: iDose TR (travoprost intracameral implant) 75 µg in conjunction with cataract surgery

Study type: Interventional

Funder types: Industry

Identifiers

NCT06848946

GLK-101-04

Details and patient eligibility

About

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

Full description

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).

Enrollment: 132 estimated patients

Sex: All

Ages: 45+ years old

Volunteers: No Healthy Volunteers

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)

Exclusion criteria

• Active corneal inflammation or edema.
• Retinal disorders not associated with glaucoma.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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132 participants in 2 patient groups

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

Active Comparator group

Description:

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

Treatment:

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

Sham procedure in conjunction with cataract surgery

Sham Comparator group

Description:

Sham procedure in conjunction with cataract surgery

Treatment:

Procedure: Sham procedure in conjunction with cataract surgery