DuoTrav APS Versus XALACOM® in Ocular Surface Health

• ClinicalTrials.gov Identifier: NCT00912054
• Recruitment Status: Terminated
• First Posted: June 3, 2009
• Last Update Posted: July 19, 2012
• Sponsor: Alcon Research
• Information provided by (Responsible Party): Alcon Research

Study Description

Brief Summary:

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

Condition or disease	Intervention/treatment	Phase
Open Angle Glaucoma; Ocular Hypertension	Drug: DuoTrav APS; Drug: Xalacom	Phase 3

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 240 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Study Start Date: March 2010
• Actual Primary Completion Date: May 2011
• Actual Study Completion Date: May 2011

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

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

Secondary Outcome Measures :

1. Percent of patients with a corneal fluorescein staining score of 0 at the end of the treatment period (Day 90) [ Time Frame: Visit 3 (Day 90) ]

Eligibility Criteria

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

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 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.

Contacts and Locations

Locations

Belgium

Cliniques Universitaires Saint Luc

Brussels, Belgium

Sponsors and Collaborators

Alcon Research

More Information

• Responsible Party: Alcon Research
• ClinicalTrials.gov Identifier: NCT00912054
• Other Study ID Numbers: C-09-007
• First Posted: June 3, 2009
• Last Update Posted: July 19, 2012
• Last Verified: January 2012

Keywords provided by Alcon Research:

OAG; OH

Additional relevant MeSH terms:

Glaucoma, Open-Angle; Ocular Hypertension; Glaucoma; Eye Diseases