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

Phase 3RecruitingNCT07075718

Glaukos Corporation610 enrolled

Overview

Evaluate the Safety and Efficacy of the Second Generation Travoprost Intracameral Implant

Evaluate the Safety and Efficacy of the Second Generation Travoprost Intracameral Implant Compared to Timolol Ophthalmic Solution 0.5% Administered Twice Daily in Subjects with Open-Angle Glaucoma or Ocular Hypertension

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

610

Conditions

Glaucoma

Interventions

Gen 2 Travoprost Intracameral ImplantDRUG

travoprost

Timolol eye drops 0.5%DRUG

timolol 0.5%

Sham ProcedurePROCEDURE

sham implant administration

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Diagnosis of open-angle glaucoma or ocular hypertension in the study eye Exclusion Criteria: * Prior incisional glaucoma surgery in the study eye * Prior argon laser trabeculoplasty (ALT) in the study eye * Prior minimally invasive glaucoma (MIGS) surgery in the study eye

Locations (3)

Glaukos Investigative Site

Grand Junction, Colorado, United States

RECRUITING

Glaukos Investigative Site

Oklahoma City, Oklahoma, United States

RECRUITING

Glaukos Clinical Site

El Paso, Texas, United States

RECRUITING

Outcomes

Primary Outcomes

Intraocular pressure (IOP)

Change from baseline in diurnal IOP in the study eye at 8AM and 10AM at each of Day 11, Week 6, and Month 3 visits

Time frame: 3 months

Central Contacts

Study Director

CONTACT

949-739-8749 idoseclinical@glaukos.com

Data from ClinicalTrials.gov

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