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 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.

Study Type: Interventional

Study Design: Treatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment

Study Primary Completion Date: April 2008

Intervention(s) in this Clinical Trial

• Drug: Travoprost 0.004% Ophthalmic Solution (Travatan)
  • Travoprost + Placebo at 9 AM & 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: 1
  • Travoprost 0.004%
• Active Comparator: 2
  • Timolol 0.5%

Primary Measures

• Mean IOP
  • Time Frame: At the 9 AM and 4 PM time points for the patient's worse eye.
    Safety Issue?: Yes

Secondary Measures

• Mean IOP reduction
  • Time Frame: Double-masked treatment phase; Week 6 examination; Week 12 examination
    Safety Issue?: Yes

Inclusion Criteria:

• ≥18 years;
• OH or OAG with visual filed abnormality: (1)≥3 adjacent points in 24o field on the same side of the horizontal meridian,that have p <5% on the PD plot,
• one of which must have p <1%(2) GHT outside normal limits(3) CPSD with p <5%;
• IOP=16-30mmHg

Exclusion Criteria:

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

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 Sponsor: Alcon Research

Information obtained from ClinicalTrials.gov on July 02, 2009

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