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

Alcon

Status and phase

Completed

Phase 4

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-08-050

Details and patient eligibility

About

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

Enrollment

236 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.
Other protocol-defined inclusion criteria may apply.

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.
Other protocol-defined exclusion criteria may apply.