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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

June 1, 2009
July 17, 2012
March 2010
May 2011   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT00912054 on ClinicalTrials.gov Archive Site
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 ]
Same as current
Not Provided
Not Provided
 
DuoTrav APS Versus XALACOM® in Ocular Surface Health
Not Provided

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

Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
  • Open Angle Glaucoma
  • Ocular Hypertension
  • Drug: DuoTrav APS
    travoprost APS 40 micrograms/ml / timolol 5 mg/ml, Eye Drops, Solution, once daily
  • Drug: Xalacom
    XALACOM® (latanoprost 50 micrograms/ml / timolol 5 mg/ml) Eye Drops, Solution
  • Experimental: 1
    DuoTrav APS
    Intervention: Drug: DuoTrav APS
  • Active Comparator: 2
    Xalacom
    Intervention: Drug: Xalacom
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
240
May 2011
May 2011   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Belgium
 
NCT00912054
C-09-007
No
Alcon Research
Alcon Research
Not Provided
Not Provided
Alcon Research
January 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP