Performance of the Travoprost Intraocular Implant

NCT06582732 | Completed Phase 2 Results FDA Drug

• 1 other identifier: IDOS-402-IVIV
• Study Type: interventional
• Target: 210
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Glaucoma, Open-Angle; Ocular Hypertension

Outcome Measures

Primary Outcomes (7)

• 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 Outcomes (7)

• Percent Residual Travoprost in Explanted Implant 12 Months Post-administration

  month 12

• Percent Residual Travoprost in Explanted Implant 3 Months Post-administration

  month 3

• Percent Residual Travoprost in Explanted Implant 6 Months Post-administration

  month 6

• Percent Residual Travoprost in Explanted Implant 24 Months Post-administration

  month 24

• Percent Residual Travoprost in Explanted Implant 21 Months Post-administration

  month 21

Study Arms (7)

Cohort 1 (12-month exchange)

EXPERIMENTAL

Travoprost Intracameral Implant Exchanged at Month 12

Drug: Travoprost Intracameral Implant exchanged at Month 12

Cohort 2 (3-month exchange)

EXPERIMENTAL

Travoprost Intracameral Implant Exchanged at Month 3

Drug: Travoprost Intracameral Implant exchanged at Month 3

Cohort 3 (6-month exchange)

EXPERIMENTAL

Travoprost Intracameral Implant Exchanged at Month 6

Drug: Travoprost Intracameral Implant exchanged at Month 6

Cohort 4 (24-month exchange)

EXPERIMENTAL

Travoprost Intracameral Implant Exchanged at Month 24

Drug: Travoprost Intracameral Implant exchanged at Month 24

Cohort 5 (21-month exchange)

EXPERIMENTAL

Travoprost Intracameral Implant Exchanged at Month 21

Drug: Travoprost intracameral implant exchanged at Month 21

Cohort 6 (18-month exchange)

EXPERIMENTAL

Travoprost Intracameral Implant Exchanged at Month 18

Drug: Travoprost intracameral implant exchanged at Month 18

Cohort 7 (15-month exchange)

EXPERIMENTAL

Travoprost Intracameral Implant Exchanged at Month 15

Drug: Travoprost intracameral implant exchanged at Month 15

Interventions

Travoprost Intracameral Implant exchanged at Month 12 DRUG

intracameral implant containing travoprost 75 mcg implanted on Day 1 and exchanged at Month 12

Also known as: iDose TR

Cohort 1 (12-month exchange)

Travoprost Intracameral Implant exchanged at Month 3 DRUG

intracameral implant containing travoprost 75 mcg implanted on Day 1 and exchanged at Month 3

Also known as: iDose TR

Cohort 2 (3-month exchange)

Travoprost Intracameral Implant exchanged at Month 6 DRUG

intracameral implant containing travoprost 75 mcg implanted on Day 1 and exchanged at Month 6

Also known as: iDose TR

Cohort 3 (6-month exchange)

Travoprost Intracameral Implant exchanged at Month 24 DRUG

intracameral implant containing travoprost 75 mcg implanted on Day 1 and exchanged at Month 24

Also known as: iDose TR

Cohort 4 (24-month exchange)

Travoprost intracameral implant exchanged at Month 21 DRUG

intracameral implant containing travoprost 75 mcg implanted on Day 1 and exchanged at Month 21

Also known as: iDose TR

Cohort 5 (21-month exchange)

Travoprost intracameral implant exchanged at Month 18 DRUG

intracameral implant containing travoprost 75 mcg implanted on Day 1 and exchanged at Month 18

Also known as: iDose TR

Cohort 6 (18-month exchange)

Travoprost intracameral implant exchanged at Month 15 DRUG

intracameral implant containing travoprost 75 mcg implanted on Day 1 and exchanged at Month 15

Also known as: iDose TR

Cohort 7 (15-month exchange)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Glaukos Corporation: lead

Study Sites (1)

Glaukos Clinical Study Site

Yerevan, Armenia

Location

Related Publications (1)

• Szekely G, Voskanyan LA, Stephens KG, Doan LV, Seal JR, ElMallah MK, Fjield T, Applegate D, Usner DW, Katz LJ, Kothe AC, Navratil T. Aqueous Humor Concentrations of Travoprost Free Acid and Residual Drug in Explanted Implants from Patients Administered a Travoprost Intracameral Implant. Ophthalmol Ther. 2025 May;14(5):989-1003. doi: 10.1007/s40123-025-01130-1. Epub 2025 Mar 24.

  PMID: 40126812 DERIVED

MeSH Terms

Conditions

Glaucoma, Open-Angle; Ocular Hypertension

Condition Hierarchy (Ancestors)

Glaucoma; Eye Diseases

Limitations and Caveats

Study was open-label, non-randomized and conducted at a single site; however, the endpoints were objective and analyses of aqueous humor concentrations of travoprost free acid and of residual travoprost in explants were performed by a third party

Results Point of Contact

• Title: Study Director
• Organization: Glaukos Corporation

ldoan@glaukos.com

714-478-2287

Study Officials

• Kerry Stephens

  Glaukos Corporation

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 30, 2024
• First Posted: September 3, 2024
• Study Start: March 10, 2021
• Primary Completion: November 2, 2023
• Study Completion: November 2, 2023
• Last Updated: October 15, 2024
• Results First Posted: October 15, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

AR (1)