Working… Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01995136
Recruitment Status : Completed
First Posted : November 26, 2013
Results First Posted : July 20, 2015
Last Update Posted : October 7, 2015
Information provided by (Responsible Party):
Alcon Research

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.

Condition or disease Intervention/treatment Phase
Normal Tension Glaucoma Ocular Hypertension Drug: Travoprost Ophthalmic Solution 0.004% Phase 4

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 32 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Investigation of the Effect of Travoprost Ophthalmic Solution of Lowering Intraocular Pressure in Patients With Normal Tension Glaucoma
Study Start Date : September 2013
Actual Primary Completion Date : June 2014
Actual Study Completion Date : June 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Glaucoma
Drug Information available for: Travoprost

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 Name: TRAVATAN Z®

Primary Outcome Measures :
  1. 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.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01995136

Layout table for location information
Alcon Japan, Ltd.
Tokyo, Japan
Sponsors and Collaborators
Alcon Research
Layout table for investigator information
Study Director: Danyel Carr, MS Alcon Japan, Ltd.
Layout table for additonal information
Responsible Party: Alcon Research Identifier: NCT01995136    
Other Study ID Numbers: M-13-047
UMIN000011621 ( Registry Identifier: UMIN )
First Posted: November 26, 2013    Key Record Dates
Results First Posted: July 20, 2015
Last Update Posted: October 7, 2015
Last Verified: October 2015
Keywords provided by Alcon Research:
Ocular hypertension
Additional relevant MeSH terms:
Layout table for MeSH terms
Ocular Hypertension
Low Tension Glaucoma
Vascular Diseases
Cardiovascular Diseases
Eye Diseases
Optic Nerve Diseases
Ophthalmic Solutions
Pharmaceutical Solutions
Antihypertensive Agents