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DuoTrav APS Versus XALACOM® in Ocular Surface Health

Sponsor
Alcon Research (Industry)
Overall Status
Terminated
CT.gov ID
NCT00912054
Collaborator
(none)
240
Enrollment
1
Location
2
Arms
14
Duration (Months)
17.1
Patients Per Site Per Month

Study Details

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
Phase 3

Study Design

Study Type:
Interventional
Actual Enrollment :
240 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
Study Start Date :
Mar 1, 2010
Actual Primary Completion Date :
May 1, 2011
Actual Study Completion Date :
May 1, 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) [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) [Visit 3 (Day 90)]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Site City State Country Postal Code
1 Cliniques Universitaires Saint Luc Brussels Belgium

Sponsors and Collaborators

  • Alcon Research

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Alcon Research
ClinicalTrials.gov Identifier:
NCT00912054
Other Study ID Numbers:
  • C-09-007
First Posted:
Jun 3, 2009
Last Update Posted:
Jul 19, 2012
Last Verified:
Jan 1, 2012
Keywords provided by Alcon Research
OAG
OH
Additional relevant MeSH terms:
Glaucoma, Open-Angle
Ocular Hypertension

Study Results

No Results Posted as of Jul 19, 2012