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

• Conditions: Open-angle glaucoma or ocular hypertension.; MedDRA version: 12.1Level: LLTClassification code 10030348Term: Open angle glaucoma; MedDRA version: 12.1Level: HLGTClassification code 10018307Term: Glaucoma and ocular hypertension; MedDRA version: 12.1Level: LLTClassification code 10030043Term: Ocular hypertension; MedDRA version: 12.1Level: LLTClassification code 10013774Term: Dry eye

• Registration Number: EUCTR2009-010604-29-AT
• Lead Sponsor: Alcon Research Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-05-06
• Last Update Posted: 3 April 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 400

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 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 with a fixed combination using 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.
9. Best-corrected visual acuity score of = 55 ETDRS letters read in each eye.

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

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 is 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. These conditions may include but are not limitating to
·Clinically significant blepharitis requiring pharmacological treatment within 3 months prior to Visit 1.
·Rosacea currently being treated with either topical or systemic therapy.
·Clinically significant corneal dystrophies (defined as affecting the structure of the corneal surface or best corrected visual acuity, or is an actively changing or unstable condition);
·Chronic or recurrent inflammatory eye diseases (e.g., uveitis, scleritis, herpes keratitis, iritis, etc).
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 endothelial automated keratoplasty (DSAEK), lamellar keratoplasty, etc.].
12. Patients with suspected or diagnosed Sjogren’s syndrome currently being treated with punctual plugs, punctual cautery, other topical ocular medications or the use of systemic therapy (e.g., RESTASIS® or EVOXAC®).
13. History of or current bronchial asthma, or severe chronic obstructive pulmonary disease that would preclude the safe administration of a topical beta-adrenergic blocking agent.
14. History of or current severe, unstable or uncontrolled cardiovascular, hepatic, or renal disease (e.g., sinus bradycardia, overt cardiac failure, greater than first degree atrioventricular block, cardiogenic shock, clinically relevant angina or uncontrolled hypertension) that would preclude the safe administration of a topical beta-adrenergic blocking agent.
15. History of spontaneous or current hypoglycemia or uncontrolled diabetes.
16. History of or current severe allergic rhinitis and bronchial hyper reactivity.
17. History of intolerance or hypersensitivity to any component of the test articles.
18. 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.
19. Use of ocular medications (including over the counter and prescription medications) other than XALACOM® within 7 days of Visit 1.
Note: Use of over-the-counter artificial tears up to the time of Visit 1 is allowed.

Study & Design

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

Primary Outcome Measures

Name	Time	Method
Main Objective: The objective of this study is to understand differences in visual function-related patient-reported outcomes, between DuoTrav APS and XALACOM®, as measured by the NEI VFQ-25 in patients with open-angle glaucoma or ocular hypertension.<br><br>PRIMARY EFFICACY<br>Primary Efficacy Variable:<br>Mean NEI VFQ-25 composite (Visual Function) score at the end of the treatment period (Day 90) <br>;Secondary Objective: SECONDARY EFFICACY<br>Mean GSS (Glaucoma Symptom Scale) composite score and mean OSSG (Ocular Surface Symptoms in Glaucoma) composite score at the end of the treatment period (Day 90);Primary end point(s): Mean change from baseline (Day 0) in Ocular Surface Disease Index (OSDI) score at the end of the treatment period (Day 90)