Travoprost Intraocular Implant in Conjunction With Cataract Surgery

NCT06061718 | Active Not Recruiting Phase 3 FDA Drug

• 1 other identifier: GLK-101-02
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Subjects with cataract requiring extraction and who have open-angle glaucoma or ocular hypertension will undergo screening and washout from IOP-lowering medication, if applicable. Eligible subjects who meet all inclusion criteria and none of the exclusion criteria and who undergo successful cataract extraction with implantation of a posterior chamber intraocular lens (PC-IOL) will receive a travoprost intraocular implant and followed up for 12 months.

Conditions

Open Angle Glaucoma; Ocular Hypertension

Outcome Measures

Primary Outcomes (1)

• Change from baseline in mean diurnal IOP

  Mean diurnal IOP at the Month 3 Visit minus the mean diurnal IOP at the Baseline Visit

  3 months

Study Arms (1)

iDose TR

EXPERIMENTAL

Travoprost Intraocular Implant administered intracamerally in the study eye at the Day 1 Visit following successful cataract surgery

Drug: iDose TR

Interventions

iDose TR DRUG

anchored intracameral implant containing travoprost

Also known as: travoprost intraocular implant

iDose TR

Eligibility Criteria

• Age: 45 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• clinically significant age-related cataract eligible for phacoemulsification in the study eye
• open-angle glaucoma or ocular hypertension in the study eye
• successful, uncomplicated cataract surgery using small incision phacoemulsification cataract surgery and insertion of a foldable posterior chamber IOL

You may not qualify if:

• unmedicated (washed out) IOP of \>36 mmHg in the study eye
• hypersensitivity to travoprost or any other components of the travoprost intraocular implant
• vertical cup/disc ratio \> 0.8 in the study eye
• best spectacle corrected visual acuity of worse than 20/80 in the fellow eye
• any ocular disease or condition that, in the opinion of the investigator, may put the subject at significant risk, may confound the study results, or may interfere significantly with the subject's participation in the study

Sponsors & Collaborators

• Glaukos Corporation: lead

Study Sites (1)

Glaukos Clinical Study Site

Yerevan, Armenia

Location

Related Publications (1)

• Singh IP, Voskanyan LA, Barber KM, Burden JH, Connolly L, Katz LJ, Usner DW, Kothe AC, Navratil T. Safety and efficacy of travoprost intracameral implant administered in combination with cataract surgery. Ther Adv Ophthalmol. 2025 Feb 14;17:25158414241310275. doi: 10.1177/25158414241310275. eCollection 2025 Jan-Dec.

  PMID: 39959854 DERIVED

MeSH Terms

Conditions

Glaucoma, Open-Angle; Ocular Hypertension

Condition Hierarchy (Ancestors)

Glaucoma; Eye Diseases

Study Officials

• Study Director

  Glaukos Corporation

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 25, 2023
• First Posted: September 29, 2023
• Study Start: September 11, 2023
• Primary Completion: March 18, 2024
• Study Completion: December 20, 2024
• Last Updated: June 3, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

AR (1)