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OpenTrials
Completed

NCT Number: NCT00670033

Travoprost New Formulations in Patients With Open-Angle Glaucoma or Ocular Hypertension

The purpose of this study was to describe the safety and IOP-lowering efficacy of Travoprost New Formulations compared to TRAVATAN® and to vehicle in patients with open-angle glaucoma or ocular hypertension.

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Key information

Conditions

Ocular Hypertension Eye Diseases Glaucoma Glaucoma, Open-Angle Open-angle Glaucoma

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Satisfy all informed consent requirements;
  • Diagnosed with open-angle glaucoma or ocular hypertension;
  • Able to discontinue use of all IOP-lowering medications for a minimum of 5 to 28 days prior to the Eligibility 1 Visit;
  • IOP measurements in at least 1 eye as specified in protocol;
  • Other protocol-specified inclusion criteria may apply.

Exclusion criteria

  • Females of childbearing potential if pregnant, breastfeeding, or not using highly effective birth control measures;
  • Any form of glaucoma other than open-angle glaucoma;
  • Severe central visual field loss in either eye;
  • Chronic, recurrent or severe inflammatory eye disease;
  • Clinically relevant or progressive retinal disease such as retinal degeneration, diabetic retinopathy, or retinal detachment, in the opinion of the Investigator;
  • Best-corrected visual acuity (BCVA) worse than 0.60 logarithm of the miniminum angle of resolution (logMAR);
  • Intraocular surgery within the past 6 months;
  • Ocular laser surgery within the past 3 months;
  • Any abnormality preventing reliable applanation tonometry;
  • Severe illness or any other conditions which would make the patient, in the opinion of the Investigator, unsuitable for the study;
  • Other protocol-specified exclusion criteria may apply.

Treatment and study plan

Travoprost ophthalmic solution (new formulation)

Drug

Travoprost ophthalmic solution, 0.004%

Drug

Other names: TRAVATAN®, TRAVATAN Z®

Vehicle

Drug

Inactive ingredients used as a placebo

Primary outcomes

  1. Mean change from baseline in intraocular pressure (IOP)

    Time frame: Baseline, Up to Week 4

    IOP (fluid pressure inside the eye) was measured by Goldmann applanation tonometry. A higher IOP can be a greater risk for developing glaucoma or glaucoma progression (leading to optic nerve damage). A more negative change indicates a greater amount of improvement.

Secondary outcomes

  1. Mean intraocular pressure

    Time frame: Baseline, Up to Week 4

    IOP (fluid pressure inside the eye) was measured by Goldmann applanation tonometry. A higher IOP can be a greater risk for developing glaucoma or glaucoma progression (leading to optic nerve damage).

  2. Mean percent change from baseline in IOP

    Time frame: Baseline, Up to Week 4

    IOP (fluid pressure inside the eye) was measured by Goldmann applanation tonometry. A higher IOP can be a greater risk for developing glaucoma or glaucoma progression (leading to optic nerve damage). A more negative percent change indicates a greater amount of improvement.

Sponsors and collaborators

Lead sponsor

Alcon Research

Industry

Registry information

Official study title

Comparison of Safety and IOP-Lowering Efficacy of Three Alternative Travoprost Formulations to Vehicle and TRAVATAN® in Patients With Open-Angle Glaucoma or Ocular Hypertension

Important dates

Study start
2008
Primary completion
2008
Study completion
2008
First posted
May 1, 2008
Registry last updated
Jul 10, 2014

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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