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
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
Eye Diseases
Vascular Diseases
Cardiovascular Diseases
Timolol
Travoprost
Cloprostenol
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Anti-Arrhythmia Agents
Cardiovascular Agents
Therapeutic Uses
Antihypertensive Agents
Luteolytic Agents
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents

ClinicalTrials.gov processed this record on April 21, 2014