DuoTrav APS Versus XALACOM® in Ocular Surface Health

To demonstrate superiority of DuoTrav APS over XALACOM® in Ocular Surface Health in patients with open angle glaucoma or ocular hypertension.

Study Overview

• Status: Terminated
• Conditions: Ocular Hypertension; Open Angle Glaucoma
• Intervention / Treatment: Drug: DuoTrav APS; Drug: Xalacom

• Study Type: Interventional
• Enrollment (Actual): 240
• Phase: Phase 3

Contacts and Locations

Study Locations

• Belgium
  • Brussels, Belgium
    • Cliniques Universitaires Saint Luc

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 be willing and able to discontinue use of any topical ocular medication other than the study medication for the duration of the study.
4. Must have had IOP controlled with mono-therapy using XALACOM for at least 1 continuous month prior to Visit 1.
5. Women of childbearing potential must meet all specific conditions at Visit 1:

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 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 who have undergone keratorefractive ocular laser procedures, corneal surgery or surgery to the corneal surface, within 1 year prior to Visit1
5. Any other ocular laser surgery in either eye within 3 months
6. Patients who have undergone intraocular or extra-ocular surgery, in either eye, within 6 months prior to Visit 1.
7. History of other progressive retinal or optic nerve disease.
8. Severe central visual field loss in either eye based upon the clinical judgment of the investigator.
9. Any history of, or current evidence of, infectious or inflammatory ocular conditions
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
12. Patients with suspected or diagnosed Sjogren's syndrome.
13. History of or current bronchial asthma, or severe chronic obstructive pulmonary disease
14. History of or current severe, unstable or uncontrolled cardiovascular, hepatic, or renal disease.
15. History of spontaneous or current hypoglycemia or uncontrolled diabetes.
16. History of or current severe allergic rhinitis and bronchial hyper reactivity.
17. Intolerance/hypersensitivity to any component of the medication
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 other than XALACOM® within 7 days
20. Use of corticosteroids within 30 days of Visit 1, or any anticipated use of corticosteroids during the course of the study.
21. Use of contact lenses within 30 days of Visit 1. Concomitant use of contact lenses is also excluded for the duration of the study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 1; DuoTrav APS	Drug: DuoTrav APS; travoprost APS 40 micrograms/ml / timolol 5 mg/ml, Eye Drops, Solution, once daily
Active Comparator: 2; Xalacom	Drug: Xalacom; XALACOM® (latanoprost 50 micrograms/ml / timolol 5 mg/ml) Eye Drops, Solution

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Mean change from baseline (Day 0) in Ocular Surface Disease at the end of the treatment period (Day 90)	Visits 1 and 3

Secondary Outcome Measures

Outcome Measure	Time Frame
Percent of patients with a corneal fluorescein staining score of 0 at the end of the treatment period (Day 90)	Visit 3 (Day 90)

Collaborators and Investigators

• Sponsor: Alcon Research

Study record dates

Study Major Dates

• Study Start: March 1, 2010
• Primary Completion (Actual): May 1, 2011
• Study Completion (Actual): May 1, 2011

Study Registration Dates

• First Submitted: June 1, 2009
• First Submitted That Met QC Criteria: June 2, 2009
• First Posted (Estimate): June 3, 2009

Study Record Updates

• Last Update Posted (Estimate): July 19, 2012
• Last Update Submitted That Met QC Criteria: July 17, 2012
• Last Verified: January 1, 2012

More Information

Terms related to this study

• Keywords: OAG; OH
• Additional Relevant MeSH Terms: Eye Diseases; Glaucoma; Glaucoma, Open-Angle; Ocular Hypertension
• Other Study ID Numbers: C-09-007