Study Comparing Travoprost Intraocular Implants to Timolol Ophthalmic Solution

Glaukos Corporation154 enrolled

Overview

This is a randomized trial comparing two elution doses of the Travoprost Intraocular implant to timolol ophthalmic solution.

This is a randomized trial comparing two elution doses of the Travoprost Intraocular implant to timolol ophthalmic solution in patients with open-angle glaucoma. Study assessments will include IOP and medication use as well as safety parameters.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

154

Conditions

Glaucoma Open-angle

Interventions

Travoprost Intraocular Implant, high elutionDRUG

Surgical implant placed within the eye to elute travoprost.

Travoprost Intraocular Implant, low elutionDRUG

Surgical implant placed within the eye to elute travoprost

Timolol Maleate Ophthalmic Solution, 0.5%DRUG

Instillation of one drop of timolol in the study eye twice daily

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Open angle glaucoma Exclusion Criteria: * Uveitic, neovascular, or angle closure glaucoma; or glaucoma associated with vascular disorders. * Functionally significant visual field loss, including severe nerve fiber bundle defects. * Prior glaucoma surgery. * Uncontrolled systemic disease, pregnant females or those planning a pregnancy. * Other ocular status conditions, etc.

Locations (1)

John Berdahl, MD

Sioux Falls, South Dakota, United States

Outcomes

Primary Outcomes

IOP (mmHg) Change From Baseline at Week 12

Change from baseline in IOP (measured in mmHg) at week 12. Negative values represent reductions in IOP from baseline.

Time frame: 12 weeks

Data from ClinicalTrials.gov

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