An Evaluation of the Ocular Surface Health in Subjects Using Travoprost APS Eye Drops Solution Versus XALATAN Eye Drops Solution. - Travoprost APS versus XALATAN in OSDI

• Conditions: Open Angle Glaucoma or Ocular Hypertension; MedDRA version: 9.1Level: LLTClassification code 10030348; MedDRA version: 9.1Level: LLTClassification code 10030043

• Registration Number: EUCTR2009-010606-10-IT
• Lead Sponsor: Alcon Research Ltd.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-04-27
• Last Update Posted: 29 May 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 700

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. Ocular Surface Disease Index (OSDI) score of >= 13. 4. Must have a corneal fluorescein staining score of >= 1 in at least one eye 5. 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. 6. 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. 7. 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. 8. The last dose of XALATAN must have been instilled the evening prior to Visit 1. 9. Must be willing and able to discontinue use of any topical ocular medication other than the study medication for the duration of the study. 10. Best-corrected visual acuity score of >= 55 ETDRS in each eye. 11.Women of childbearing potential must meet all of the following conditions at Visit 1: They are not breast-feeding. They have a negative urine pregnancy test at Visit 1. They agree to undertake a urine pregnancy test upon entering and exiting the study. They are not planning to become pregnant during the course of the study. They are currently using, and agree to continue to use adequate birth control methods for the duration of the study.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

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 which has been, or is 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. 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 1 year 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. 10. Any history of, or current evidence of, infectious or inflammatory ocular conditions (mild, moderate or severe) in either eye. These conditions may include, but are not limited to: Clinically significant blepharitis (requiring pharmacological treatment) within 2 years prior to Visit 1. 11. Ocular trauma within 6 months prior to Visit 1 in either eye, as determined by patient history and/or examination. 12. Use of any systemic medications on a chronic basis that have not been on a stable dosing regimen for at least 30 days prior to Visit 1, or an anticipated change in dosing regimen of medications during the course of the study. 13. Use of ocular medications (including over the counter and prescription medications) other than XALATAN within 7 days of Visit 1. 14. Use of corticosteroids within 30 days of Visit 1, or any anticipated use of corticosteroids during the course of the study. 15. Use of contact lenses within 30 days of Visit 1. Concomitant use of contact lenses is also excluded for the duration of the study. 16. History of intolerance or hypersensitivity to any component of the test articles. 17. Participation in an investigational drug or device study within 30 days of entering this study. 18. History or evidence of corneal transplant or transplant variant procedures [Descemet?s stripping endothelial keratoplasty (DSEK), Descemet?s stripping endothelial automated keratoplasty (DSAEK), lamellar keratoplasty, etc.]. Additionally, in rare circumstances, a patient may be declared ineligible for a valid medical reason [e.g., patients demonstrating a medical condition (systemic or ophthalmic) not specified above that may preclude the safe administration of test article or safe participation in this study, or that may affect the results of this study].

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified