NL-OMON35130
Completed
Phase 3
An Evaluation of Patient Reported Outcomes and Ocular Surface Health in Patients Using DuoTrav APS Eye Drops Solution Versus XALACOM® Eye Drops Solution. - DuoTrav APS versus XALACOM® in Ocular Surface Health
Alcon Laboratories0 sites30 target enrollmentTBD
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- raised intra-ocular pressure with optic nerve damage
- Sponsor
- Alcon Laboratories
- Enrollment
- 30
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility 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 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)
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 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.
Outcomes
Primary Outcomes
Not specified
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