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

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.

Full Title of Study: “Investigation of the Effect of Travoprost Ophthalmic Solution of Lowering Intraocular Pressure in Patients With Normal Tension Glaucoma”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: June 2014

Interventions

  • Drug: Travoprost Ophthalmic Solution 0.004%
    • benzalkonium chloride (BAC) free

Arms, Groups and Cohorts

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

Clinical Trial Outcome Measures

Primary Measures

  • Mean Change From Baseline in IOP (9:00 AM) at Week 4, Week 8, and Week 12
    • Time Frame: Baseline (Day 0), Week 4, Week 8, 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.

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 20 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Alcon Research
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Danyel Carr, MS, Study Director, Alcon Japan, Ltd.

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