Performance of the Travoprost Intraocular Implant

September 19, 2024 updated by: Glaukos Corporation

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
210

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Armenia
      • Yerevan, Armenia
        • Glaukos Clinical Study Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Travoprost Free Acid Concentration (ng/mL) in Aqueous Humor 12 Months Post-administration
Time Frame: month 12
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
Time Frame: month 3
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
Time Frame: month 6
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
Time Frame: month 24
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
Time Frame: month 21
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
Time Frame: month 18
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
Time Frame: month 15
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Percent Residual Travoprost in Explanted Implant 12 Months Post-administration
Time Frame: month 12
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
Time Frame: month 3
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
Time Frame: month 6
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
Time Frame: month 24
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
Time Frame: month 21
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
Time Frame: month 18
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
Time Frame: month 15
percent of travoprost compared to baseline in explanted implant 15 months post-administration as assessed by HPLC
month 15

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Glaukos Corporation

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Kerry Stephens, Glaukos Corporation

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 10, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 2, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 2, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 30, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 30, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 3, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 15, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 19, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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