Effects of Travatan Z and Xalatan on Ocular Surface Health

NCT ID: NCT00708422

Last Updated: 2012-04-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 231 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-07-31
• Study Completion Date: 2009-08-31

Brief 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.

Conditions

Glaucoma; Ocular Hypertension

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Travoprost

One drop self-administered in the study eye(s) once daily at night for 12 weeks

Group Type: EXPERIMENTAL

Travoprost ophthalmic solution 0.004% with SofZia® preservative system (TRAVATAN Z®)

Intervention Type: DRUG

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.

Latanoprost

One drop self-administered in the study eye(s) once daily at night for 12 weeks

Group Type: ACTIVE_COMPARATOR

Latanoprost ophthalmic solution 0.005% (XALATAN®)

Intervention Type: DRUG

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.

Interventions

Travoprost ophthalmic solution 0.004% with SofZia® preservative system (TRAVATAN Z®)

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.

Intervention Type: DRUG

Latanoprost ophthalmic solution 0.005% (XALATAN®)

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 Type: DRUG

Other Intervention Names

TRAVATAN Z®; travoprost; XALATAN®; latanoprost

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.

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Alcon Research

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Judy Vittitoe, RN, MPH

Role: STUDY_DIRECTOR

Alcon Research

Other Identifiers

SMA-08-07

Identifier Type: -

Identifier Source: org_study_id