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

Study Overview
=================
Brief Summary
-----------------
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.

Official Title
-----------------
Investigation of the Effect of Travoprost Ophthalmic Solution of Lowering Intraocular Pressure in Patients With Normal Tension Glaucoma

Conditions
-----------------
Normal Tension Glaucoma, Ocular Hypertension

Intervention / Treatment
-----------------
* Drug: Travoprost Ophthalmic Solution 0.004%


Participation Criteria
=================
Eligibility Criteria
-----------------
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.

Ages Eligible for Study
-----------------
Minimum Age: 20 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TRAVATAN Z<br>Travoprost Ophthalmic Solution 0.004%, 1 drop instilled in each eye once daily at 9PM for 3 months. | Drug: Travoprost Ophthalmic Solution 0.004%<br>* benzalkonium chloride (BAC) free<br>* Other names: TRAVATAN Z®;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Baseline (Day 0), Week 4, Week 8, Week 12 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Glaucoma, Ocular hypertension