Phase 4
Completed N=236
Examination of Ocular Surface Effects With Administration of Travatan Z and XALATAN
Source: ClinicalTrials.gov NCT00798759 ↗Enrolled (actual)
236
Serious AEs
1.3%
Results posted
Apr 2012
Primary outcomePrimary: Mean Change at 12 Weeks (Day 84) From Baseline (Day 0) in Tear Film Break-Up Time (TFBUT) — 0.7; 0.6 Seconds
Summary
The purpose of this study is to compare two ophthalmic solutions in patients with open-angle glaucoma or ocular hypertension.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Change at 12 Weeks (Day 84) From Baseline (Day 0) in Tear Film Break-Up Time (TFBUT) |
0.7; 0.6 | — |
| SECONDARY Mean Change at 12 Weeks (Day 84) From Baseline (Day 0) in Ocular Surface Disease Index (OSDI) Score |
-1.9; 0.6 | — |
Eligibility Criteria
Inclusion Criteria
- 18 years or older.
- Diagnosis of open-angle glaucoma or ocular hypertension in at least one eye.
- Intraocular pressure (IOP) controlled with BAK (benzalkonium chloride) preserved IOP-lowering medication for 1 year, with last 6 months on XALATAN® monotherapy.
- Best corrected visual acuity of -0.6 logMAR or better in each eye.
- Other protocol-defined inclusion criteria may apply.
Exclusion Criteria
- Treatment with BAK preserved artificial tears within 30 days of Visit 1.
- Known or suspected Sjogren's disease.
- Uncontrolled IOP.
- History or evidence of infectious or inflammatory ocular conditions.
- Progressive retinal or optic nerve disease.
- Ocular laser surgery within 3 months of Visit 1.
- Keratorefractive ocular laser procedures, corneal surgery or surgery to the corneal surface within 1 year of Visit 1.
- Current use of punctal plugs or punctal cautery.
- Use of systemic medications that has not been stable for 30 days prior to Visit 1.
- Use of contact lens within 30 days of Visit 1.
- Other protocol-defined exclusion criteria may apply.
Data sourced from ClinicalTrials.gov (NCT00798759). 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.