Phase III Clinical Trial of TRAVATAN Z in Ocular Surface Health

NCT ID: NCT00761319

Last Updated: 2012-04-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 705 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-10-31
• Study Completion Date: 2009-09-30

Brief Summary

The purpose of the 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 for 90 days

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 90 days. Referred to as travoprost.

Latanoprost

One drop self-administered in the study eye(s) once daily for 90 days

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 90 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 90 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 90 days. Referred to as latanoprost.

Intervention Type: DRUG

Other Intervention Names

TRAVATAN Z®; XALATAN®

Eligibility Criteria

Inclusion Criteria

• 18 years or older.
• Ocular Surface Disease Index (OSDI) score and corneal fluorescein staining score as specified in protocol.
• Diagnosis of open-angle glaucoma or ocular hypertension in at least one eye.
• Intraocular pressure (IOP) controlled with latanoprost 0.005% (XALATAN®) for at least one continuous month prior to Visit 1.
• Willing and able to discontinue use of any topical ocular medicine other than the study medication for the duration of the study, including artificial tears.
• Best corrected visual acuity of -0.6 logMAR or better in each eye.

Exclusion Criteria

• Any medical condition (systemic or ophthalmic) that may preclude safe administration of the test article.
• Use of contact lenses within 30 days of Visit 1.
• Use of contact lenses during the study.
• Participation in an investigational drug or device study within 30 days of entering this study.

• 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-08-047

Identifier Type: -

Identifier Source: org_study_id