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

This study has been completed.
Sponsor:
Information provided by:
Alcon Research
ClinicalTrials.gov Identifier:
NCT00763061
First received: September 26, 2008
Last updated: February 23, 2010
Last verified: February 2010
  Purpose

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.


Condition Intervention Phase
Glaucoma
Drug: Travoprost 0.004% Ophthalmic Solution (Travatan)
Drug: Timolol 0.5% Ophthalmic Solution (Timoptic)
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official 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

Resource links provided by NLM:


Further study details as provided by Alcon Research:

Primary Outcome Measures:
  • Mean Intraocular Pressure (IOP) at 9 AM [ Time Frame: At Week 12 - At the 9 AM time point for the patient's worse eye. ] [ Designated as safety issue: Yes ]
    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.

  • Week 12 - Mean IOP At 4 PM [ Time Frame: At the 4 PM time point for the patient's worse eye. ] [ Designated as safety issue: Yes ]
    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 Outcome Measures:
  • Mean IOP Change From Baseline at 9 AM [ Time Frame: Baseline to Week 12 - at 9 AM ] [ Designated as safety issue: Yes ]
    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.

  • Mean IOP Change at 4 PM [ Time Frame: Baseline to Week 12 - at 4 PM ] [ Designated as safety issue: Yes ]
    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.


Enrollment: 111
Study Start Date: May 2006
Study Completion Date: April 2008
Primary Completion Date: April 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Travoprost 0.004%
Travoprost 0.004%
Drug: Travoprost 0.004% Ophthalmic Solution (Travatan)
Travoprost at 9 AM + Placebo & 9 PM
Active Comparator: Timolol 0.5%
Timolol 0.5%
Drug: Timolol 0.5% Ophthalmic Solution (Timoptic)
Timolol in each eye, twice daily at 9 AM & 9 PM

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • ≥18 years;
  • IOP=16-30mmHg
  • OH or OAG with visual filed abnormality:

    1. ≥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%,
    2. Glaucoma Hemifield Test outside normal limits,
    3. 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.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00763061

Locations
United States, Texas
Alcon Call Center
Fort Worth, Texas, United States, 76134
Sponsors and Collaborators
Alcon Research
  More Information

No publications provided

Responsible Party: Benny Li, Ph.D., Alcon Research Ltd
ClinicalTrials.gov Identifier: NCT00763061     History of Changes
Other Study ID Numbers: MS-06-02
Study First Received: September 26, 2008
Results First Received: April 28, 2009
Last Updated: February 23, 2010
Health Authority: Hong Kong: Department of Health

Keywords provided by Alcon Research:
Glaucoma

Additional relevant MeSH terms:
Glaucoma
Glaucoma, Open-Angle
Hypertension
Ocular Hypertension
Cardiovascular Diseases
Eye Diseases
Vascular Diseases
Ophthalmic Solutions
Pharmaceutical Solutions
Timolol
Travoprost
Adrenergic Agents
Adrenergic Antagonists
Adrenergic beta-Antagonists
Anti-Arrhythmia Agents
Antihypertensive Agents
Cardiovascular Agents
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on October 22, 2014