Investigation of Intraocular Pressure (IOP) Reduction Efficacy of Travoprost Ophthalmic Solution in Patients With Normal Tension Glaucoma

Phase 4CompletedNCT01995136

Alcon Research32 enrolled

Overview

The purpose of this study is to investigate IOP reduction efficacy of travoprost 0.004% ophthalmic solution (TRAVATAN Z®) in subjects with normal tension glaucoma.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Normal Tension Glaucoma Ocular Hypertension

Interventions

Travoprost Ophthalmic Solution 0.004%DRUG

benzalkonium chloride (BAC) free

Eligibility

Sex: ALLMin age: 20 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Diagnosis of normal tension glaucoma. * Must sign an Informed Consent form. * IOP within protocol-specified range. * Other protocol-specified inclusion criteria may apply. Exclusion Criteria: * Pregnant and lactating women, or women who intend to become pregnant during the study period. * Advanced and serious glaucoma, as specified in protocol. * Complicated chronic or recurrent uveitis, scleritis or corneal herpes. * History of ocular trauma, intraocular surgery or laser surgery for the included eye. * Ocular-infection and severe ocular complication. * Best-corrected visual acuity (BCVA) worse than 0.2 decimal. * Difficulty in conducting applanation tonometry for the included eye as determined by the doctor. * Severe or serious hypersensitivity to prostaglandin analogues or any ingredients used in the study. * Use of IOP lowering ophthalmic solutions other than TRAVATAN Z® or oral carbonic anhydrase inhibitor (Diamox, etc.) during the study period. * Use of any adrenocorticosteroids during the study period. * Use of IOP lowering ophthalmic solution within the past 30 days. * Regarded by doctor as not suitable for study participation. * Other protocol-specified exclusion criteria may apply.

Locations (1)

Alcon Japan, Ltd.

Tokyo, Japan

Outcomes

Primary Outcomes

Mean Change From Baseline in IOP (9:00 AM) at Week 4, Week 8, and Week 12

IOP (fluid pressure inside the eye) was assessed using Goldmann applanation tonometry and measured in millimeters of mercury (mmHg). Data at 9:00 AM from Weeks 4, 8, and 12 were pooled. A more negative change indicates a greater amount of improvement. One eye (study eye) was subject to analysis.

Time frame: Baseline (Day 0), Week 4, Week 8, Week 12

Data from ClinicalTrials.gov

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