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Phase 4 Completed N=231 Randomized Triple-blind Treatment

Effects of Travatan Z and Xalatan on Ocular Surface Health

Source: ClinicalTrials.gov NCT00708422 ↗
Enrolled (actual)
231
Serious AEs
0.9%
Results posted
Apr 2012
Primary outcomePrimary: Mean Change at 12 Weeks (Day 84) From Baseline (Day 0) in Tear Film Break Up Time (TBUT) — 0.8; 1.1 seconds

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.

Outcome Measures

OutcomeResultp-value
PRIMARY
Mean Change at 12 Weeks (Day 84) From Baseline (Day 0) in Tear Film Break Up Time (TBUT)
0.8; 1.1
SECONDARY
Mean Change at 12 Weeks (Day 84) From Baseline (Day 0) in Ocular Surface Disease Index (OSDI) Score
-0.0; -1.3

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.
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00708422). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.

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