Phase III Clinical Trial of TRAVATAN Z in Ocular Surface Health

Alcon

Status and phase

Completed

Phase 3

Conditions

Open-angle Glaucoma

Ocular Hypertension

Treatments

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

Drug: Latanoprost ophthalmic solution 0.005% (XALATAN®)

Study type

Interventional

Funder types

Industry

Identifiers

C-08-047

Details and patient eligibility

About

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

Enrollment

705 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.
Other protocol-defined inclusion criteria may apply.

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.
Other protocol-defined exclusion criteria may apply.