Examination of Ocular Surface Effects With Administration of Travatan Z and XALATAN

NCT ID: NCT00798759

Last Updated: 2012-06-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 236 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-12-31
• Study Completion Date: 2009-05-31

Brief Summary

The purpose of this study is to compare two ophthalmic solutions in patients with open-angle glaucoma or ocular hypertension.

Conditions

Open-angle Glaucoma; Ocular Hypertension

Study Design

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

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®; XALATAN®

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.

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.

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

Sponsors

Alcon Research

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

C-08-050

Identifier Type: -

Identifier Source: org_study_id