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

September 26, 2008
February 23, 2010
May 2006
April 2008   (final data collection date for primary outcome measure)
  • 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.
Mean IOP [ Time Frame: At the 9 AM and 4 PM time points for the patient's worse eye. ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT00763061 on ClinicalTrials.gov Archive Site
  • 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.
Mean IOP reduction [ Time Frame: Double-masked treatment phase; Week 6 examination; Week 12 examination ]
Not Provided
Not Provided
 
Travatan Versus Timoptic in Treating Open-angle Glaucoma or Ocular Hypertension
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

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.

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.

Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Glaucoma
  • Drug: Travoprost 0.004% Ophthalmic Solution (Travatan)
    Travoprost at 9 AM + Placebo & 9 PM
  • Drug: Timolol 0.5% Ophthalmic Solution (Timoptic)
    Timolol in each eye, twice daily at 9 AM & 9 PM
  • Experimental: Travoprost 0.004%
    Travoprost 0.004%
    Intervention: Drug: Travoprost 0.004% Ophthalmic Solution (Travatan)
  • Active Comparator: Timolol 0.5%
    Timolol 0.5%
    Intervention: Drug: Timolol 0.5% Ophthalmic Solution (Timoptic)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
111
April 2008
April 2008   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00763061
MS-06-02
No
Benny Li, Ph.D., Alcon Research Ltd
Alcon Research
Not Provided
Not Provided
Alcon Research
February 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP