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

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”

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.

Intervention(s) in this Clinical Trial

• 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

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: Travoprost 0.004%
  • Travoprost 0.004%
• Active Comparator: Timolol 0.5%
  • Timolol 0.5%

Primary 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.
    Safety Issue?: Yes
• Week 12 - Mean IOP At 4 PM
  • Time Frame: At the 4 PM time point for the patient's worse eye.
    Safety Issue?: Yes

Secondary Measures

• Mean IOP Change From Baseline at 9 AM
  • Time Frame: Baseline to Week 12 - at 9 AM
    Safety Issue?: Yes
• Mean IOP Change at 4 PM
  • Time Frame: Baseline to Week 12 - at 4 PM
    Safety Issue?: Yes

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.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Investigator: Alcon Research Industry

Information obtained from ClinicalTrials.gov on February 12, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00763061

Study ID Number: MS-06-02

ClinicalTrials.gov Identifier: NCT00763061

Health Authority: Hong Kong: Department of Health