Performance of the Travoprost Intraocular Implant

Prospective, Non-Randomized, Open-Label, Single Center Study to Evaluate the Performance of the Travoprost Intraocular Implant

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

Study Overview

• Status: Completed
• Conditions: Ocular Hypertension; Glaucoma, Open-Angle
• Intervention / Treatment: Drug: Travoprost Intracameral Implant exchanged at Month 12; Drug: Travoprost Intracameral Implant exchanged at Month 3; Drug: Travoprost Intracameral Implant exchanged at Month 6; Drug: Travoprost Intracameral Implant exchanged at Month 24; Drug: Travoprost intracameral implant exchanged at Month 21; Drug: Travoprost intracameral implant exchanged at Month 18; Drug: Travoprost intracameral implant exchanged at Month 15

• Study Type: Interventional
• Enrollment (Actual): 210
• Phase: Phase 2

Contacts and Locations

Study Locations

• Armenia
  • Yerevan, Armenia
    • Glaukos Clinical Study Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

7

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cohort 1 (12-month exchange); Travoprost Intracameral Implant Exchanged at Month 12	Drug: Travoprost Intracameral Implant exchanged at Month 12; intracameral implant containing travoprost 75 mcg implanted on Day 1 and exchanged at Month 12; Other Names: iDose TR
Experimental: Cohort 2 (3-month exchange); Travoprost Intracameral Implant Exchanged at Month 3	Drug: Travoprost Intracameral Implant exchanged at Month 3; intracameral implant containing travoprost 75 mcg implanted on Day 1 and exchanged at Month 3; Other Names: iDose TR
Experimental: Cohort 3 (6-month exchange); Travoprost Intracameral Implant Exchanged at Month 6	Drug: Travoprost Intracameral Implant exchanged at Month 6; intracameral implant containing travoprost 75 mcg implanted on Day 1 and exchanged at Month 6; Other Names: iDose TR
Experimental: Cohort 4 (24-month exchange); Travoprost Intracameral Implant Exchanged at Month 24	Drug: Travoprost Intracameral Implant exchanged at Month 24; intracameral implant containing travoprost 75 mcg implanted on Day 1 and exchanged at Month 24; Other Names: iDose TR
Experimental: Cohort 5 (21-month exchange); Travoprost Intracameral Implant Exchanged at Month 21	Drug: Travoprost intracameral implant exchanged at Month 21; intracameral implant containing travoprost 75 mcg implanted on Day 1 and exchanged at Month 21; Other Names: iDose TR
Experimental: Cohort 6 (18-month exchange); Travoprost Intracameral Implant Exchanged at Month 18	Drug: Travoprost intracameral implant exchanged at Month 18; intracameral implant containing travoprost 75 mcg implanted on Day 1 and exchanged at Month 18; Other Names: iDose TR
Experimental: Cohort 7 (15-month exchange); Travoprost Intracameral Implant Exchanged at Month 15	Drug: Travoprost intracameral implant exchanged at Month 15; intracameral implant containing travoprost 75 mcg implanted on Day 1 and exchanged at Month 15; Other Names: iDose TR

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Travoprost Free Acid Concentration (ng/mL) in Aqueous Humor 12 Months Post-administration	concentration of travoprost free acid (ng/mL) in the aqueous humor 12 months post-administration as assessed by liquid chromatography tandem mass spectrometry (LC-MS/MS)	month 12
Travoprost Free Acid Concentration (ng/mL) in Aqueous Humor 3 Months Post-administration	concentration of travoprost free acid (ng/mL) in the aqueous humor 3 months post-administration as assessed by LC-MS/MS	month 3
Travoprost Free Acid Concentration (ng/mL) in Aqueous Humor 6 Months Post-administration	concentration of travoprost free acid (ng/mL) in the aqueous humor 6 months post-administration as assessed by LC-MS/MS	month 6
Travoprost Free Acid Concentration (ng/mL) in Aqueous Humor 24 Months Post-administration	concentration of travoprost free acid (ng/mL) in the aqueous humor 24 months post-administration as assessed by LC-MS/MS	month 24
Travoprost Free Acid Concentration(ng/mL) in Aqueous Humor 21 Months Post-administration	concentration of travoprost free acid (ng/mL) in the aqueous humor 21 months post-administration as assessed by LC-MS/MS	month 21
Travoprost Free Acid Concentration (ng/mL) in Aqueous Humor 18 Months Post-administration	concentration of travoprost free acid (ng/mL) in the aqueous humor 18 months post-administration as assessed by LC-MS/MS	month 18
Travoprost Free Acid Concentration (ng/mL) in Aqueous Humor 15 Months Post-administration	concentration of travoprost free acid (ng/mL) in the aqueous humor 15 months post-administration as assessed by LC-MS/MS	month 15

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percent Residual Travoprost in Explanted Implant 12 Months Post-administration	percent of travoprost compared to baseline in explanted implant 12 months post-administration as assessed by high performance liquid chromatography (HPLC)	month 12
Percent Residual Travoprost in Explanted Implant 3 Months Post-administration	percent of travoprost compared to baseline in explanted implant 3 months post-administration as assessed by HPLC	month 3
Percent Residual Travoprost in Explanted Implant 6 Months Post-administration	percent of travoprost compared to baseline in explanted implant 6 months post-administration as assessed by HPLC	month 6
Percent Residual Travoprost in Explanted Implant 24 Months Post-administration	percent of travoprost compared to baseline in explanted implant 24 months post-administration as assessed by HPLC	month 24
Percent Residual Travoprost in Explanted Implant 21 Months Post-administration	percent of travoprost compared to baseline in explanted implant 21 months post-administration as assessed by HPLC	month 21
Percent Residual Travoprost in Explanted Implant 18 Months Post-administration	percent of travoprost compared to baseline in explanted implant 18 months post-administration as assessed by HPLC	month 18
Percent Residual Travoprost in Explanted Implant 15 Months Post-administration	percent of travoprost compared to baseline in explanted implant 15 months post-administration as assessed by HPLC	month 15

Collaborators and Investigators

• Sponsor: Glaukos Corporation
• Investigators: Study Director: Kerry Stephens, Glaukos Corporation

Study record dates

Study Major Dates

• Study Start (Actual): March 10, 2021
• Primary Completion (Actual): November 2, 2023
• Study Completion (Actual): November 2, 2023

Study Registration Dates

• First Submitted: August 30, 2024
• First Submitted That Met QC Criteria: August 30, 2024
• First Posted (Actual): September 3, 2024

Study Record Updates

• Last Update Posted (Actual): October 15, 2024
• Last Update Submitted That Met QC Criteria: September 19, 2024
• Last Verified: September 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Glaucoma; Glaucoma, Open-Angle; Ocular Hypertension; Antihypertensive Agents; Travoprost
• Other Study ID Numbers: IDOS-402-IVIV

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No