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Effects of Travatan Z and Xalatan on Ocular Surface Health

Information source: Alcon Research
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Glaucoma; Ocular Hypertension

Intervention: Travoprost ophthalmic solution 0.004% with SofZia® preservative system (TRAVATAN Z®) (Drug); Latanoprost ophthalmic solution 0.005% (XALATAN®) (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Alcon Research

Official(s) and/or principal investigator(s):
Judy Vittitoe, RN, MPH, Study Director, Affiliation: Alcon Research

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.

Clinical Details

Official title: Examination of Ocular Surface Effects With Administration of TRAVATAN Z and Xalatan

Study design: Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: Mean Change at 12 Weeks (Day 84) From Baseline (Day 0) in Tear Film Break Up Time (TBUT)

Secondary outcome: Mean Change at 12 Weeks (Day 84) From Baseline (Day 0) in Ocular Surface Disease Index (OSDI) Score

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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.

Locations and Contacts

Additional Information

Starting date: July 2008
Last updated: March 30, 2012

Page last updated: August 23, 2015

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