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View Clinical Trial (Medical Research Study)
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DuoTrav APS Versus XALACOM® in Ocular Surface Health - NCT00912054-76134 (Clinical Trial 296196)
Permalink: http://www.ClinicalConnection.com/exp/ExpandedPatientViewStudy296196.aspx
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| City: |
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Fort Worth |
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State:
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TX |
| Zip Code: |
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76134 |
| Conditions: |
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Open Angle Glaucoma - Ocular Hypertension |
| Purpose: |
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To demonstrate superiority of DuoTrav APS over XALACOM® in Ocular Surface Health in patients
with open angle glaucoma or ocular hypertension.
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| Study summary: |
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| Criteria: |
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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. |
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| Study is available at: |
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Alcon Call Center for Trial Locations
Fort Worth, TX 76134
United States
Primary Contact:
Alcon Call Center
Email: medical.information@alconlabs.com
Phone: 1-888-451-3937 |
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If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
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| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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March 16, 2010 |
Modifications to
this listing: |
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Only selected fields are shown, please use the link
above to view all information about this clinical trial. |
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Clinical trials are medical research studies designed to test the safety and/or
effectiveness of new drugs, devices, or treatments in humans. These studies are
conducted worldwide for a range of conditions and illnesses. Learn more about
clinical research and participating in a study at
About Clinical Trials.
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