Study of Exchange of Travoprost Intraocular Implant

Prospective, Non-Randomized, Open-Label, Multi-Center, Single Arm Study of Exchange of Travoprost Intraocular Implant

The study objective is to evaluate the safety of the operative and surgical exchange procedure of Travoprost Intraocular Implant in subjects with open-angle glaucoma or ocular hypertension.

Study Overview

• Status: Completed
• Conditions: Open Angle Glaucoma
• Intervention / Treatment: Drug: Travoprost

Detailed Description

This prospective, non-randomized, open-label, multi-center, single arm, clinical trial intends to implant approximately 45 male and female subjects over 18 years old who have been diagnosed with open-angle glaucoma (OAG) or ocular hypertension (OHT). All subjects are required to meet eligibility criteria at Visit 1 (Screening). The purpose of this study is to evaluate the safety of the implantation and exchange of a Travoprost Intraocular Implant in subjects with open-angle glaucoma or ocular hypertension. Postoperatively, there are 6 follow-up visits over a 12 month period.

• Study Type: Interventional
• Enrollment (Actual): 33
• Phase: Phase 2

Contacts and Locations

Study Locations

• Philippines
  • Makati City, Philippines
    • Asian Eye Institute
• United States
  • California
    • Hemet, California, United States, 92545
      • Inland Eye Specialists
    • Petaluma, California, United States, 94954
      • North Bath Eye Associates, Inc.
  • Colorado
    • Fort Collins, Colorado, United States, 80525
      • Eye Center of Northern Colorado, PC
  • Florida
    • Manatee, Florida, United States, 34209
      • The Eye Associates of Manatee
    • Ocala, Florida, United States, 34471
      • Ocala Eye
    • Sarasota, Florida, United States, 34239
      • Center For Sight
  • Iowa
    • Sioux City, Iowa, United States, 51104
      • Jones Eye Clinic
  • Massachusetts
    • Lancaster, Massachusetts, United States, 01523
      • D'Ambrosio Eye Care
  • New Jersey
    • South Orange, New Jersey, United States, 07079
      • Northern New Jersey Eye Institute
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73112
      • Oklahoma Eye Surgeons
  • South Dakota
    • Sioux Falls, South Dakota, United States, 57108
      • Vance Thompson Vision
  • Texas
    • Austin, Texas, United States, 78746
      • Texan Eye
    • Nacogdoches, Texas, United States, 75965
      • Lehmann Eye Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Able and willing to attend scheduled follow-up exams for the duration of the study
• Able and willing to provide written informed consent on the IRB (institutional review board)/IEC (institutional ethics committee)-approved Informed Consent form
• Best spectacle corrected visual acuity of 20/80 or better in each eye.
• Previously qualified for GC-009 clinical trial using the Travoprost Intraocular Implant with the travoprost intraocular implant (G2TR) that is present in the study eye.

Exclusion Criteria:

• Glaucoma status as follows:

  • Traumatic, uveitic, neovascular, or angle-closure glaucoma; or glaucoma associated with vascular disorders

• Corneal status as follows:

  • Any active inflammation or edema
• Any pathology for which, in the investigator's judgement, the following would be either at risk or contraindicated:
• Implantation of Travoprost Intraocular Implant
• Compliance to elements of the study protocol (e.g., ophthalmic examinations, follow-up visits)

• Fellow eye status as follows:

  • Fellow eye actively enrolled in this trial or any other clinical trial

• Subject status as follows:

  • Pregnant or planning to become pregnant during the course of the study

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Implantation and Exchange; Subjects will undergo implantation and exchange of a Travoprost Intraocular Implant through a small temporal clear corneal incision.	Drug: Travoprost; Implantation and exchange of a Travoprost Intraocular Implant through a clear corneal incision

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Ocular Safety	Number of subjects with Adverse Events including intra-operative and post-operative events (TEAE's) in the study eye	12 Months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intraocular Pressure	Intraocular Pressure (IOP) in millimeters of Mercury (mmHg)	12 Months
Visual Acuity	Corrected Visual Acuity measured from ETDRS Visual Acuity Chart	12 Months
Corneal Edema	Slit Lamp Biomicroscopy Findings of the eye and adnexa. Findings to be assessed include: Corneal Edema (Scale: none, mild, moderate, or severe)	12 Months
Corneal Opacity	Slit Lamp Biomicroscopy Findings of the eye and adnexa. Findings to be assessed include: Corneal Opacity (Scale: none, mild, moderate, or severe)	12 Months
Corneal Epithelium	Slit Lamp Biomicroscopy Findings of the eye and adnexa. Findings to be assessed include: Corneal Epithelium (Normal, or Punctate staining presence)	12 Months
Corneal Endothlium	Slit Lamp Biomicroscopy Findings of the eye and adnexa. Findings to be assessed include: Corneal Endothelium (Scale: Normal, 1 fold, 2 folds, 3 folds, 4 folds)	12 Months
Anterior Chamber Cells	Slit Lamp Biomicroscopy Findings of the eye and adnexa. Findings to be assessed include: Anterior Chamber Cells (Scale: <1 cells, 1-5 cells, 6-15 cells, 16-25 cells, 26-50 cells, or >50 cells)	12 Months
Anterior Chamber Flare	Slit Lamp Biomicroscopy Findings of the eye and adnexa. Findings to be assessed include: Anterior Chamber Flare (Scale: None, Faint, Moderate, Marked, Intense)	12 Months
Iris - Neovascularization	Slit Lamp Biomicroscopy Findings of the eye and adnexa. Findings to be assessed include: Iris - Neovascularization (No, or Yes)	12 Months
Iris - Atrophy	Slit Lamp Biomicroscopy Findings of the eye and adnexa. Findings to be assessed include: Iris - Atrophy (No, or Yes)	12 Months
Iris - Pigment Dispersion	Slit Lamp Biomicroscopy Findings of the eye and adnexa. Findings to be assessed include: Iris - Pigment Dispersion (No, or Yes)	12 Months
Pupil	Slit Lamp Biomicroscopy Findings of the eye and adnexa. Findings to be assessed include: Pupil (normal, abnormal)	12 Months
Lens Status	Slit Lamp Biomicroscopy Findings of the eye and adnexa. Findings to be assessed include: Lens Status - phakic/psedophakic; if opacity present grading (Opacity location and severity) graded using the Age-Related Eye Disease Study (AREDS) Clinical Lens Grading System (ARLNS) Implant Assessment - (Location, Iris Touch, Endothelial Touch)	12 Months
Gonioscopy	Gonioscopy findings of the anterior chamber and angle of the eye	12 Months
Specular Microscopy	Specular Microscopy Findings of corneal endothelium	12 Months
Dilated Fundus Examination	Dilated Fundus examination performed via ophthalmoscopy including cup-to-disc ratio	12 Months
Visual Field	Visual Field changes in Mean Deviation over time (MD of visual field loss)	12 Months

Collaborators and Investigators

• Sponsor: Glaukos Corporation

Study record dates

Study Major Dates

• Study Start (Actual): November 19, 2020
• Primary Completion (Actual): February 28, 2022
• Study Completion (Actual): February 28, 2022

Study Registration Dates

• First Submitted: October 29, 2020
• First Submitted That Met QC Criteria: November 3, 2020
• First Posted (Actual): November 4, 2020

Study Record Updates

• Last Update Posted (Actual): September 26, 2023
• Last Update Submitted That Met QC Criteria: September 7, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Ocular Hypertension; Glaucoma; Glaucoma, Open-Angle; Antihypertensive Agents; Travoprost
• Other Study ID Numbers: IDOS-106-EXCH

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