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OpenTrials
Completed

NCT Number: NCT06582732

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

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Key information

Conditions

Glaucoma, Open-Angle Eye Diseases Glaucoma Ocular Hypertension

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Glaukos Clinical Study Site

Yerevan, Armenia

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Travoprost Intracameral Implant exchanged at Month 12

Drug

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

Other names: iDose TR

Travoprost Intracameral Implant exchanged at Month 3

Drug

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

Other names: iDose TR

Travoprost Intracameral Implant exchanged at Month 6

Drug

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

Other names: iDose TR

Travoprost Intracameral Implant exchanged at Month 24

Drug

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

Other names: iDose TR

Travoprost intracameral implant exchanged at Month 21

Drug

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

Other names: iDose TR

Travoprost intracameral implant exchanged at Month 18

Drug

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

Other names: iDose TR

Travoprost intracameral implant exchanged at Month 15

Drug

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

Other names: iDose TR

Primary outcomes

  1. 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)

  2. 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

  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

  4. 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

  5. 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

  6. 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

  7. 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

Secondary outcomes

  1. 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)

  2. 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

  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

  4. 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

  5. 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

  6. 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

  7. 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

Sponsors and collaborators

Lead sponsor

Glaukos Corporation

Industry

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Sep 3, 2024
Registry last updated
Oct 15, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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