An Evaluation of Patient Reported Outcomes and Ocular Surface Health in Patients Using Travoprost APS Eye Drops Solution Versus XALATAN Eye Drops Solution - Travoprost APS versus XALATAN® in Patient Reported Outcomes and Ocular Surface Health

Alcon Research, Ltd.0 sites516 target enrollmentApril 22, 2009

DrugsXalatan

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Not specified
Sponsor: Alcon Research, Ltd.
Enrollment: 516
Status: Active, not recruiting
Last Updated: 13 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

April 22, 2009

End Date

TBD

Last Updated

13 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Investigators

Sponsor

Alcon Research, Ltd.

Eligibility Criteria

Inclusion Criteria

•All patients must meet the following criteria:
•1\. Patients \= 18 years of age.
•2\. Must have a clinical diagnosis of open\-angle glaucoma (with or without pseudoexfoliation or pigment dispersion component), or ocular hypertension in at least one eye.
•3\. Must have a corneal fluorescein staining score of \= 1 in at least one eye
•Note: If the patient is currently dosing with XALATAN® in only one eye, the eye being dosed must be the one with corneal staining. If the patient is currently dosing both eyes, staining must be present in at least one eye. Scoring should be based on staining that is, in the opinion of the investigator, typical of staining found in patients with chronic use of preserved eye drops.
•4\. Must have had their IOP controlled with mono\-therapy using latanoprost 50 micrograms/ml eye drops (XALATAN®) for at least 1 continuous month immediately prior to Visit 1\.
•5\. The intraocular pressure should be able to be controlled in the opinion of the Investigator and stable while on mono\-therapy with the study medication for the eye(s) currently being dosed with XALATAN®.
•6\. Must have an intraocular pressure in both eyes that, in the opinion of the Investigator, is considered to be stable and safe for the patient.
•7\. The last dose of XALATAN® must have been instilled the evening prior to Visit 1\.
•8\. Must be willing and able to discontinue use of any topical ocular medication other than the study medication for the duration of the study.

Exclusion Criteria

•Patients demonstrating any medical condition (systemic or ophthalmic) that may preclude the safe administration of test article or safe participation in this study, or that may in the opinion of the Investigator, affect the results of this study SHOULD NOT be enrolled. The following are specific conditions that exclude patients from enrollment in this study:
•1\. Any abnormality preventing reliable applanation tonometry in the study eye(s).
•2\. Presence of any ocular pathology in either eye seen during the slit lamp or fundus exams, that in the opinion of the Investigator may preclude the safe administration of test article or safe participation in this study.
•3\. Dry eye or KCS currently being treated with the use of punctal plugs, punctal cautery, Restasis®, or topical ocular corticosteroids.
•4\.Patients with suspected or diagnosed Sjogren’s syndrome currently being treated with with punctal plugs, punctal cautery, other topical ocular medications or the use of systemic therapy (e.g., RESTASIS® or EVOXAC®).
•5\. Patients who have undergone keratorefractive ocular laser procedures, corneal surgery or surgery to the corneal surface, including but not limited to LASIK and PRK, within 6 months prior to Visit 1\.
•6\. Any other ocular laser surgery in either eye within 3 months prior to Visit 1\.
•7\. Patients who have undergone intraocular or extra\-ocular surgery, in either eye, within 6 months prior to Visit 1\.
•8\. History of progressive retinal or optic nerve disease other than glaucoma.
•9\. Severe central visual field loss in either eye based upon the clinical judgment of the investigator. For Humphrey and Octopus perimeters severe central visual field loss is defined as a sensitivity of less than or equal to 10 dB in at least two (2\) of the four (4\) visual field test points closest to the point of fixation.