Effects of Travatan Z and Xalatan on Ocular Surface Health
Condition: Glaucoma; Ocular Hypertension
MeSH terms: Glaucoma; Ocular Hypertension; Hypertension
Intervention: Travoprost ophthalmic solution 0.004% with SofZia® preservative system (TRAVATAN Z®); Latanoprost ophthalmic solution 0.005% (XALATAN®)
Intervention description: Ophthalmic solution for the treatment of open-angle glaucoma or ocular hypertension, one drop a day, dosed topically for 12 weeks (84 days). Referred to as travoprost.; Ophthalmic solution for the treatment of open-angle glaucoma or ocular hypertension, one drop a day, dosed topically for 12 weeks (84 days). Referred to as latanoprost.
Intervention MeSH terms: Travoprost; Pharmaceutical Solutions; Latanoprost; Ophthalmic Solutions
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 231.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Ocular surface health; OSDI; TFBUT; Glaucoma; Ocular hypertension; Corneal staining

Summary:

      The purpose of this randomized, double-masked, parallel-group, multicenter study is to
      evaluate ocular surface effects after the administration of travoprost with SofZia®
      preservative system or Xalatan once daily for 12 weeks.
    

Eligibility criteria:

        Inclusion Criteria:

          -  18 years of age or older.

          -  Diagnosis of primary open-angle glaucoma (with or without pseudoexfoliation or pigment
             dispersion) or ocular hypertension in at least one eye (study eye).

          -  Use of BAK (benzalkonium chloride) containing intraocular pressure (IOP) lowering
             medication for a minimum of one year, including latanoprost (Xalatan®) monotherapy for
             at least 6 months prior to Visit 1.

          -  IOP controllable and stable on the study medication alone (both eyes).

          -  Believed to have ocular surface disease (OSD).

          -  Tear Break-up Time (TBUT) of ≤ 6 seconds in the study eye.

          -  Willing and able to discontinue the use of any topical ocular medication other than
             the study medication or BAK free artificial tears for the duration of the study.

          -  Other protocol-defined inclusion criteria may apply.

        Exclusion Criteria:

          -  Current use or use within the last 3 months of cyclosporine ophthalmic emulsion 0.05%
             (Restasis®), topical ocular steroids, or topical ocular non-steroidal
             anti-inflammatory drugs.

          -  Current use of punctual plugs.

          -  Women of childbearing potential not using reliable means of birth control.

          -  Women who are pregnant or lactating.

          -  Suspected or diagnosed with Sjogrens's syndrome.

          -  Current use of any brand of artificial tears containing BAK.

          -  Use of any systemic medications on a chronic basis not on a stable dosing regimen for
             at least 30 days prior to Visit 1, or an anticipated change in dosing regimen of
             medications during the course of the study.

          -  Intraocular conventional surgery or laser surgery in study eyes less than six months
             prior to Visit 1.

          -  Current use of contact lenses within 30 days of Visit 1.

          -  Participation in any other investigational study within 30 days prior to Visit 1.

          -  Other protocol-defined exclusion criteria may apply.