A Multicenter Study of the Pigmentation in the Trabecular Meshwork After Two Years of Treatment With TRAVATAN 0.004% Ophthalmic Solution

The purpose of this study was to assess the pigmentation in the trabecular meshwork of patients who had been treated for at least 2 years with TRAVATAN compared with patients without exposure (or less than 1 month) to a prostaglandin analogue (PGA).

Patients were identified and enrolled from 9 study centers in the US and 1 in Spain.

• Procedure: Trabecular Meshwork Tissue Collection
  A minimum of two punches were used to remove tissue to form a sclerostomy. Tissue removed by the punch was collected for analysis. Alternatively, the tissue was collected by block excision of the meshwork with scissors at the time of sclerostomy.
• Drug: Travoprost 0.004% ophthalmic solution
  Other Names:

  • TRAVATAN Z
  • TRAVATAN

• TRAVATAN
  As prescribed by physician for the treatment of open-angle glaucoma and dosed for at least two years
  Interventions:

  • Procedure: Trabecular Meshwork Tissue Collection
  • Drug: Travoprost 0.004% ophthalmic solution
• Treatment Naive
  No prior exposure (or less than 1 month) to any topical, ocular prostaglandin analogue
  Intervention: Procedure: Trabecular Meshwork Tissue Collection

Inclusion Criteria:

• Diagnosis of open-angle glaucoma without pseudoexfoliation or pigment dispersion component;
• Either two or more years of dosing with Travatan, or no prior exposure (less than 1 month) to a topical ocular prostaglandin;
• Requires a trabeculectomy;
• Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

• Pseudoexfoliation or pigment dispersion;
• History of chronic or recurrent severe inflammatory eye disease;
• History of or current ocular infection or ocular inflammation within the past 3 months in either eye;
• Greater than one month but less than two years of exposure to TRAVATAN;
• Pregnant, breast-feeding, not using highly effective birth control;
• Other protocol-defined exclusion criteria may apply.