DuoTrav APS Versus XALACOM® in Ocular Surface Health

This study has been terminated.
(poor enrollment)
Sponsor:
Information provided by (Responsible Party):
Alcon Research
ClinicalTrials.gov Identifier:
NCT00912054
First received: June 1, 2009
Last updated: July 17, 2012
Last verified: January 2012
  Purpose

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


Condition Intervention Phase
Open Angle Glaucoma
Ocular Hypertension
Drug: DuoTrav APS
Drug: Xalacom
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Alcon Research:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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) ] [ Designated as safety issue: Yes ]

Enrollment: 240
Study Start Date: March 2010
Study Completion Date: May 2011
Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00912054

Locations
Belgium
Cliniques Universitaires Saint Luc
Brussels, Belgium
Sponsors and Collaborators
Alcon Research
  More Information

No publications provided

Responsible Party: Alcon Research
ClinicalTrials.gov Identifier: NCT00912054     History of Changes
Other Study ID Numbers: C-09-007
Study First Received: June 1, 2009
Last Updated: July 17, 2012
Health Authority: Australia: Human Research Ethics Commission

Keywords provided by Alcon Research:
OAG
OH

Additional relevant MeSH terms:
Glaucoma, Open-Angle
Hypertension
Ocular Hypertension
Cardiovascular Diseases
Eye Diseases
Glaucoma
Vascular Diseases

ClinicalTrials.gov processed this record on October 22, 2014