Performance of the Travoprost Intraocular Implant

Glaukos

Status and phase: Completed; Phase 2

Conditions: Ocular Hypertension; Glaucoma, Open-Angle

Treatments: Drug: Travoprost intracameral implant exchanged at Month 21; Drug: Travoprost intracameral implant exchanged at Month 15; Drug: Travoprost Intracameral Implant exchanged at Month 24; Drug: Travoprost Intracameral Implant exchanged at Month 6; Drug: Travoprost Intracameral Implant exchanged at Month 3; Drug: Travoprost Intracameral Implant exchanged at Month 12; Drug: Travoprost intracameral implant exchanged at Month 18

Study type: Interventional

Funder types: Industry

Identifiers

NCT06582732

IDOS-402-IVIV

Details and patient eligibility

About

To evaluate the performance of the Travoprost Intracameral Implant by determining residual drug in explanted implants of the Travoprost Intracameral Implant and by determining aqueous humor concentrations of travoprost free acid at specified timepoints post administration through 24 months

Enrollment: 210 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Diagnosis of either open angle glaucoma (i.e. primary, pseudoexfoliation, or pigmentary glaucoma) or ocular hypertenson
• Zero to three topical intraocular pressure lowering medications at the time of Visit 1 (Screening) exam.
• Best spectacle corrected visual acuity of 16 letters or more correctly read at 4 meters or better in each eye.
• Open angle as defined by Shaffer grade ≥ 3 at slit-lamp at the planned implantation site

Exclusion criteria

• Traumatic, uveitic, neovascular, or angle-closure glaucoma; or glaucoma associated with vascular disorders
• Active ocular inflammation, infection or edema
• Clinically significant dystrophy (e.g., bullous keratopathy, Fuch's dystrophy) or clinically significant guttata

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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210 participants in 7 patient groups

Cohort 1 (12-month exchange)

Experimental group

Description:

Travoprost Intracameral Implant Exchanged at Month 12

Treatment:

Drug: Travoprost Intracameral Implant exchanged at Month 12

Cohort 2 (3-month exchange)

Experimental group

Description:

Travoprost Intracameral Implant Exchanged at Month 3

Treatment:

Drug: Travoprost Intracameral Implant exchanged at Month 3

Cohort 3 (6-month exchange)

Experimental group

Description:

Travoprost Intracameral Implant Exchanged at Month 6

Treatment:

Drug: Travoprost Intracameral Implant exchanged at Month 6

Cohort 4 (24-month exchange)

Experimental group

Description:

Travoprost Intracameral Implant Exchanged at Month 24

Treatment:

Drug: Travoprost Intracameral Implant exchanged at Month 24

Cohort 5 (21-month exchange)

Experimental group

Description:

Travoprost Intracameral Implant Exchanged at Month 21

Treatment:

Drug: Travoprost intracameral implant exchanged at Month 21

Cohort 6 (18-month exchange)

Experimental group

Description:

Travoprost Intracameral Implant Exchanged at Month 18

Treatment:

Drug: Travoprost intracameral implant exchanged at Month 18

Cohort 7 (15-month exchange)

Experimental group

Description:

Travoprost Intracameral Implant Exchanged at Month 15

Treatment:

Drug: Travoprost intracameral implant exchanged at Month 15