Performance of the Travoprost Intraocular Implant

Glaukos Corporation210 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

210

Conditions

Glaucoma, Open-Angle Ocular Hypertension

Interventions

Travoprost Intracameral Implant exchanged at Month 12DRUG

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

Travoprost Intracameral Implant exchanged at Month 3DRUG

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

Travoprost Intracameral Implant exchanged at Month 6DRUG

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Glaukos Clinical Study Site

Yerevan, Armenia

Outcomes

Primary Outcomes

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)

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: month 18

Travoprost Free Acid Concentration (ng/mL) in Aqueous Humor 15 Months Post-administration

Data from ClinicalTrials.gov

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Secondary Outcomes

Percent Residual Travoprost in Explanted Implant 12 Months Post-administration

percent of travoprost compared to baseline in explanted implant 12 months post-administration as assessed by high performance liquid chromatography (HPLC)

Time frame: month 12

Percent Residual Travoprost in Explanted Implant 3 Months Post-administration

percent of travoprost compared to baseline in explanted implant 3 months post-administration as assessed by HPLC

Time frame: month 3

Percent Residual Travoprost in Explanted Implant 6 Months Post-administration

percent of travoprost compared to baseline in explanted implant 6 months post-administration as assessed by HPLC

Time frame: month 6

Percent Residual Travoprost in Explanted Implant 24 Months Post-administration

percent of travoprost compared to baseline in explanted implant 24 months post-administration as assessed by HPLC

Time frame: month 24

Percent Residual Travoprost in Explanted Implant 21 Months Post-administration

percent of travoprost compared to baseline in explanted implant 21 months post-administration as assessed by HPLC

Time frame: month 21

Percent Residual Travoprost in Explanted Implant 18 Months Post-administration

percent of travoprost compared to baseline in explanted implant 18 months post-administration as assessed by HPLC

Time frame: month 18

Percent Residual Travoprost in Explanted Implant 15 Months Post-administration

percent of travoprost compared to baseline in explanted implant 15 months post-administration as assessed by HPLC

Time frame: month 15