Clinical trial NCT06582732: Performance of the Travoprost Intraocular Implant
Official title: Prospective, Non-Randomized, Open-Label, Single Center Study to Evaluate the Performance of the Travoprost Intraocular Implant
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Glaucoma, Open-Angle
Ocular Hypertension
Lead sponsor: Glaukos Corporation
Sponsor class: INDUSTRY
First posted: 2024-09-03
Enrollment: 210
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: 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


Eligibility criteria: 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

Primary outcomes:
measure: Travoprost Free Acid Concentration (ng/mL) in Aqueous Humor 12 Months Post-administration
timeFrame: month 12
measure: Travoprost Free Acid Concentration (ng/mL) in Aqueous Humor 3 Months Post-administration
timeFrame: month 3
measure: Travoprost Free Acid Concentration (ng/mL) in Aqueous Humor 6 Months Post-administration
timeFrame: month 6
measure: Travoprost Free Acid Concentration (ng/mL) in Aqueous Humor 24 Months Post-administration
timeFrame: month 24
measure: Travoprost Free Acid Concentration(ng/mL) in Aqueous Humor 21 Months Post-administration
timeFrame: month 21
measure: Travoprost Free Acid Concentration (ng/mL) in Aqueous Humor 18 Months Post-administration
timeFrame: month 18
measure: Travoprost Free Acid Concentration (ng/mL) in Aqueous Humor 15 Months Post-administration
timeFrame: month 15
Secondary outcomes:
measure: Percent Residual Travoprost in Explanted Implant 12 Months Post-administration
timeFrame: month 12
measure: Percent Residual Travoprost in Explanted Implant 3 Months Post-administration
timeFrame: month 3
measure: Percent Residual Travoprost in Explanted Implant 6 Months Post-administration
timeFrame: month 6
measure: Percent Residual Travoprost in Explanted Implant 24 Months Post-administration
timeFrame: month 24
measure: Percent Residual Travoprost in Explanted Implant 21 Months Post-administration
timeFrame: month 21
measure: Percent Residual Travoprost in Explanted Implant 18 Months Post-administration
timeFrame: month 18
measure: Percent Residual Travoprost in Explanted Implant 15 Months Post-administration
timeFrame: month 15
Other outcomes:
Locations:
city: Yerevan
country: Armenia
facility: Glaukos Clinical Study Site
Study officials:
affiliation: Glaukos Corporation
name: Kerry Stephens
role: STUDY_DIRECTOR
References: