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OpenTrials
Completed

NCT Number: NCT01995136

Investigation of Intraocular Pressure (IOP) Reduction Efficacy of Travoprost Ophthalmic Solution 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.

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Key information

Conditions

Normal Tension Glaucoma Eye Diseases Glaucoma Low Tension Glaucoma Ocular Hypertension Optic Nerve Diseases

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Alcon Japan, Ltd.

Tokyo, Japan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

travoprost ophthalmic solution 0.004%

Drug

benzalkonium chloride (BAC) free

Other names: TRAVATAN Z®

Primary outcomes

  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.

Sponsors and collaborators

Lead sponsor

Alcon Research

Industry

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Nov 26, 2013
Registry last updated
Oct 7, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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