Performance of the Travoprost Intraocular Implant

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

210 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-03-10

Study Completion Date

2023-11-02

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Clinical Study Comparing Two Models of a Travoprost Intraocular Implant

NCT03868124

Glaucoma, Open-Angle Ocular Hypertension

COMPLETED PHASE3

Travoprost Intraocular Implant + iStent Infinite vs. iStent Infinite Alone

NCT06066645

Glaucoma, Open-Angle

RECRUITING PHASE3

Travoprost Intraocular Implant in Conjunction With Cataract Surgery

NCT06061718

Open Angle Glaucoma Ocular Hypertension

ACTIVE_NOT_RECRUITING PHASE3

Phase 2/Phase 3 Trial to Evaluate the Safety and Efficacy of the Second Generation Travoprost Intracameral Implant

NCT07075718

Glaucoma

RECRUITING PHASE2/PHASE3

Study of Exchange of Travoprost Intraocular Implant

NCT04615403

Open Angle Glaucoma

COMPLETED PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Glaucoma, Open-Angle Ocular Hypertension

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Cohort 1 (12-month exchange)

Travoprost Intracameral Implant Exchanged at Month 12

Group Type EXPERIMENTAL

Travoprost Intracameral Implant exchanged at Month 12

Intervention Type DRUG

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

Cohort 2 (3-month exchange)

Travoprost Intracameral Implant Exchanged at Month 3

Group Type EXPERIMENTAL

Travoprost Intracameral Implant exchanged at Month 3

Intervention Type DRUG

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

Cohort 3 (6-month exchange)

Travoprost Intracameral Implant Exchanged at Month 6

Group Type EXPERIMENTAL

Travoprost Intracameral Implant exchanged at Month 6

Intervention Type DRUG

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

Cohort 4 (24-month exchange)

Travoprost Intracameral Implant Exchanged at Month 24

Group Type EXPERIMENTAL

Travoprost Intracameral Implant exchanged at Month 24

Intervention Type DRUG

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

Cohort 5 (21-month exchange)

Travoprost Intracameral Implant Exchanged at Month 21

Group Type EXPERIMENTAL

Travoprost intracameral implant exchanged at Month 21

Intervention Type DRUG

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

Cohort 6 (18-month exchange)

Travoprost Intracameral Implant Exchanged at Month 18

Group Type EXPERIMENTAL

Travoprost intracameral implant exchanged at Month 18

Intervention Type DRUG

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

Cohort 7 (15-month exchange)

Travoprost Intracameral Implant Exchanged at Month 15

Group Type EXPERIMENTAL

Travoprost intracameral implant exchanged at Month 15

Intervention Type DRUG

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Travoprost Intracameral Implant exchanged at Month 12

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

Intervention Type DRUG

Travoprost Intracameral Implant exchanged at Month 3

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

Intervention Type DRUG

Travoprost Intracameral Implant exchanged at Month 6

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

Intervention Type DRUG

Travoprost Intracameral Implant exchanged at Month 24

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

Intervention Type DRUG

Travoprost intracameral implant exchanged at Month 21

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

Intervention Type DRUG

Travoprost intracameral implant exchanged at Month 18

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

Intervention Type DRUG

Travoprost intracameral implant exchanged at Month 15

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

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

iDose TR iDose TR iDose TR iDose TR iDose TR iDose TR iDose TR

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No