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

Alcon Research, Ltd.0 sites400 target enrollmentMay 3, 2010

Conditionsglaucoma/dry eye MedDRA version: 9.1Level: LLTClassification code 10030348Term: Open angle glaucoma MedDRA version: 9.1Level: HLGTClassification code 10018307Term: Glaucoma and ocular hypertension MedDRA version: 9.1Level: LLTClassification code 10030043Term: Ocular hypertension MedDRA version: 9.1Level: LLTClassification code 10013774Term: Dry eye

DrugsXalacom (Xalcom)

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: glaucoma/dry eye
Sponsor: Alcon Research, Ltd.
Enrollment: 400
Status: Active, not recruiting
Last Updated: 14 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

May 3, 2010

End Date

TBD

Last Updated

14 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Investigators

Sponsor

Alcon Research, Ltd.

Eligibility Criteria

Inclusion 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 XALACOM® 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 using only the fixed combination XALACOM® for at least 1 continuous month immediately prior to Visit 1 in at least one eye.
•5\. The intraocular pressure should be able to be controlled in the opinion of the Investigator and stable while on fixed combination with the study medication for the eye(s) currently being dosed with XALACOM®.
•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 XALACOM® must have been instilled within 24 hours of 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.
•NOTE: This includes discontinuation of any artificial tears.

Exclusion Criteria

•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 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\.
•5\. Any other ocular laser surgery in either eye within 3 months prior to Visit 1\.
•6\. Patients who have undergone intraocular or extra\-ocular surgery, in either eye, within 6 months prior to Visit 1\.
•7\. History of progressive retinal or optic nerve disease other than glaucoma.
•8\. Severe central visual field loss in either eye based upon the clinical judgment of the Investigator.
•9\. Any history of ocular infections or inflammatory ocular conditions within the past 3 months in either eye. 10\. Ocular trauma within 6 months prior to Visit 1 in either eye, as determined by patient history and/or examination.
•11\. History or evidence of corneal transplant or transplant variant procedures \[Descemet’s stripping endothelial keratoplasty (DSEK), Descemet’s stripping automated endothelial keratoplasty (DSAEK), lamellar keratoplasty, etc.].