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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-09-30

Study Completion Date

2014-06-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Normal Tension Glaucoma Ocular Hypertension

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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TRAVATAN Z

Travoprost Ophthalmic Solution 0.004%, 1 drop instilled in each eye once daily at 9PM for 3 months.

Group Type EXPERIMENTAL

Travoprost Ophthalmic Solution 0.004%

Intervention Type DRUG

benzalkonium chloride (BAC) free

Interventions

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Travoprost Ophthalmic Solution 0.004%

benzalkonium chloride (BAC) free

Intervention Type DRUG

Other Intervention Names

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TRAVATAN Z®

Eligibility Criteria

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Inclusion Criteria

* Diagnosis of normal tension glaucoma.
* Must sign an Informed Consent form.
* IOP within protocol-specified range.

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.

Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No