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Completed

NCT Number: NCT00763061

Travatan Versus Timoptic in Treating Open-angle Glaucoma or Ocular Hypertension

To evaluate the Intraocular Pressure (IOP) lowering efficacy and safety of Travoprost 0.004% compared to Timolol 0.5% in patients with open-angle glaucoma (OAG) or ocular hypertension (OH). The study structure is a parallel design. The patients will receive treatment for 12 weeks.

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Key information

Conditions

Glaucoma Eye Diseases Ocular Hypertension

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Alcon Call Center

Fort Worth, Texas, 76134, United States

About this study

To evaluate the IOP lowering efficacy and safety fo Travoprost 0.004% compared to Timolol 0.5% in patients with open-angle glaucoma (OAG) or ocular hypertension (OH). The study structure is a parallel design. The patients will receive treatment for 12 weeks.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • ≥18 years;
  • IOP=16-30mmHg
  • OH or OAG with visual filed abnormality:
  • ≥3 adjacent points in 24 degrees field on the same side of the horizontal meridian, that have p <5% on the prepapillary diameter plot, one of which must have p <1%,
  • Glaucoma Hemifield Test outside normal limits,
  • Corrected Pattern Standard Deviation with p <5%

Exclusion criteria

  • Previous damage of anterior chamber angle;
  • ocular inflammation or ocular surgery within the past 3 months; Best Corrected Visual Acuity (logMAR) <1.0;
  • contact lens wearer;
  • severe central field loss;
  • uncontrolled cardiovascular, hepatic or renal disease;
  • any medication within past 1 month.

Treatment and study plan

Travoprost 0.004% Ophthalmic Solution (Travatan)

Drug

Travoprost at 9 AM + Placebo & 9 PM

Timolol 0.5% Ophthalmic Solution (Timoptic)

Drug

Timolol in each eye, twice daily at 9 AM & 9 PM

Primary outcomes

  1. Mean Intraocular Pressure (IOP) at 9 AM

    Time frame: At Week 12 - At the 9 AM time point for the patient's worse eye.

    Bilateral IOP measurements by Goldmann applanation were performed at 9AM and 4 PM. Two IOP measurements were taken and averaged. If the difference between the first and second reading was greater than 4 mmHg, a third reading was taken and the two nearest readings averaged.

  2. Week 12 - Mean IOP At 4 PM

    Time frame: At the 4 PM time point for the patient's worse eye.

    Bilateral IOP measurements by Goldmann applanation were performed at 9AM and 4 PM. Two IOP measurements were taken and averaged. If the difference between the first and second reading was greater than 4 mmHg, a third reading was taken and the two nearest readings averaged.

Secondary outcomes

  1. Mean IOP Change From Baseline at 9 AM

    Time frame: Baseline to Week 12 - at 9 AM

    Bilateral IOP measurements by Goldmann applanation were performed at 9AM and 4 PM. Two IOP measurements were taken and averaged. If the difference between the first and second reading was greater than 4 mmHg, a third reading was taken and the two nearest readings averaged.

  2. Mean IOP Change at 4 PM

    Time frame: Baseline to Week 12 - at 4 PM

    Bilateral IOP measurements by Goldmann applanation were performed at 9AM and 4 PM. Two IOP measurements were taken and averaged. If the difference between the first and second reading was greater than 4 mmHg, a third reading was taken and the two nearest readings averaged.

Sponsors and collaborators

Lead sponsor

Alcon Research

Industry

Registry information

Official study title

A Twelve-Week, Double Masked, Parallel Group, Study of Travoprost 0.004% Compared to Timolol 0.5% in Patients With Open-Angle Glaucoma or Ocular Hypertension

Important dates

Study start
2006
Primary completion
2008
Study completion
2008
First posted
Sep 30, 2008
Registry last updated
Mar 2, 2010

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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