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

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ClinicalTrials.gov Identifier: NCT01995136
Recruitment Status : Completed
First Posted : November 26, 2013
Results First Posted : July 20, 2015
Last Update Posted : October 7, 2015
Sponsor:
Information provided by (Responsible Party):
Alcon Research

Study Description
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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

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 32 participants
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

Arms and Interventions
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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®


Outcome Measures
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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.


Eligibility Criteria
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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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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 ClinicalTrials.gov identifier (NCT number): NCT01995136


Locations
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Japan
Alcon Japan, Ltd.
Tokyo, Japan
Sponsors and Collaborators
Alcon Research
Investigators
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Study Director: Danyel Carr, MS Alcon Japan, Ltd.
More Information
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Responsible Party: Alcon Research
ClinicalTrials.gov Identifier: NCT01995136     History of Changes
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:
Glaucoma
Ocular hypertension
Additional relevant MeSH terms:
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Glaucoma
Ocular Hypertension
Low Tension Glaucoma
Hypertension
Vascular Diseases
Cardiovascular Diseases
 Eye Diseases
Optic Nerve Diseases
Travoprost
Ophthalmic Solutions
Pharmaceutical Solutions
Antihypertensive Agents