An Evaluation of Patient Reported Outcomes and Ocular Surface Health in Patients Using DuoTrav APS Eye Drops Solution Versus XALACOM® Eye Drops Solution.
- Conditions
- raised intra-ocular pressure with optic nerve damageraised intra-ocular pressure without optic nerve damage10018307
- Registration Number
- NL-OMON35130
- Lead Sponsor
- Alcon Laboratories
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 30
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 have a corneal fluorescein staining score of * 1 in at least one eye.
4. Must have had their IOP controlled using only the fixed combination XALACOM® for at least 1 continuous month immediately prior to Visit 1 in at least one eye.
5. The IOP should be able to be controlled in the opinion of the Investigator and stable while on fixed combination with the study medication for the eye(s) currently being dosed with XALACOM®
6. Must have an IOP in both eyes that, in the opinion of the investigator, is considered to be stable and safe for the patient.
7. The last dose of XALACOM® must have been instilled within 24 hours of Visit 1.
8. Must be willing and able to discontinue use of any topical ocular medication other than the study medication for the duration of the study.
9. Best-corrected visual acuity score of *55 ETDRS letters read in each eye.
10. Women of childbearing potential must meet all of the following conditions at Visit 1: they are not breast-feeding; they have a negative urine pregnancy test at Visit 1; they agree to undertake a urine pregnancy test upon entering and exiting the study; they are not planning to become pregnant during the course of the study; they are currently using, and agree to continue to use adequate birth control methods for the duration of the study (hormonal, mechanical, surgical or abstinence)
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 in the opinion of the Investigator may preclude the safe administration of test article or safe participation in this study.
3. Dry eye or KCS 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, including but not limited to LASIK and PRK, within 6 months prior to Visit 1.
5. Any other ocular laser surgery in either eye within 3 months prior to Visit 1.
6. Patients who have undergone intraocular or extra-ocular surgery, in either eye, within 6 months prior to Visit 1.
7. History of progressive retinal or optic nerve disease other than glaucoma.
8. Severe central visual field loss in either eye based upon the clinical judgement of the Investigator.
9. Any history of ocular infections or inflammatory ocular conditions within the past 3 months in either eye.
10. Ocular trauma within 6 months prior to Visit 1 in either eye.
11. History or evidence of corneal transplant or transplant variant procedures.
12. Patients with suspected or diagnosed Sjogren*s syndrome currently being treated with punctual plugs, punctual cautery, other topical ocular medications or the use of systemic therapy.
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 hyperreactivity.
17. History of intolerance or hypersensitivity to any component of the test articles.
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 (including over the counter and prescription medications) other than XALACOM® within 7 days of Visit 1.
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.
22. Participation in an investigational drug or device study within 30 days of entering this study.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Mean NEI VFQ-25 composite (Visual Function) score at the end of the treatment<br /><br>period (Day 90). A two-sample t-test will be used to test for differences<br /><br>between treatments in the means.</p><br>
- Secondary Outcome Measures
Name Time Method <p>Mean OSSG (Ocular Surface Symptoms in Glaucoma) composite score at the end of<br /><br>the treatment period (Day 90). A two-sample t-test will be used to test for<br /><br>differences between treatments in the means for each variable.</p><br>