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

October 5, 2015 updated by: Alcon Research

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

32

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
      • Tokyo, Japan
        • Alcon Japan, Ltd.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: TRAVATAN Z
Travoprost Ophthalmic Solution 0.004%, 1 drop instilled in each eye once daily at 9PM for 3 months.
Drug: Travoprost Ophthalmic Solution 0.004%
benzalkonium chloride (BAC) free
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
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.
Baseline (Day 0), Week 4, Week 8, Week 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Alcon Research

Investigators

  • Study Director: Danyel Carr, MS, Alcon Japan, Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2013

Primary Completion (ACTUAL)

June 1, 2014

Study Completion (ACTUAL)

June 1, 2014

Study Registration Dates

First Submitted

November 21, 2013

First Submitted That Met QC Criteria

November 21, 2013

First Posted (ESTIMATE)

November 26, 2013

Study Record Updates

Last Update Posted (ESTIMATE)

October 7, 2015

Last Update Submitted That Met QC Criteria

October 5, 2015

Last Verified

October 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • M-13-047
  • UMIN000011621 (REGISTRY: UMIN)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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