Exploratory Study Comparing Signs and Symptoms in Patients With Ocular Hypertension or Glaucoma U… (NCT00799682) | Clinical Trial Compass
CompletedPhase 4
Exploratory Study Comparing Signs and Symptoms in Patients With Ocular Hypertension or Glaucoma Using Xalatan R® or Travatan Z®
United States56 participantsStarted 2008-10
Plain-language summary
The purpose of this study is to determine if there is a difference in the ocular signs and symptoms of subjects' eyes using Xalatan® 0.005% versus Travatan Z® 0.004% based on the outcome of subject assessment and clinical assessment in patients with Ocular Hypertension or Glaucoma with mild to moderate dry eye at baseline in accordance with the Oxford Grading Scale.
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* Male or Female 18 years of age or older
* Only patients who satisfy all informed consent requirements may be included in the study
* Be likely to complete the entire course of study and comply with study drop regimen, guidelines and visits
* Able to understand drop instructions and instill study drops
* Patients must be on monotherapy for Ocular Hypertension or Glaucoma and agree to a washout period, as according to Appendix E
* Patient has Ocular Hypertension, chronic Open-Angle Glaucoma, chronic Angle-Closure Glaucoma with patent iridotomy/iridectomy, Pseudo Exfoliate Glaucoma, or Pigmentary Glaucoma in each eye at screening visit.
* Patients using systemic non-glaucoma medications known to lower IOP may be included, if on stable dose \>30 days prior to screening visit and agree to maintain the regimen throughout the course of the study.
* Patients using non-prescription eye drops or prescription topical eye drops for dry eye may be included, if on stable dose 30 days prior to screening visit and agree to maintain the regimen throughout the course of the study.
* Patients who wear contact lenses with a maintained wearing pattern for the duration of the study
* Best Corrected LogMar VA of ≤0.70 =(20/100 Snellen equivalent)
* Hyperemia Grading ≤2
* IOP ≤ 30 mmHg
* Shirmers 3mm - 9.75mm
* Tear break-up time (TBUT) 4 seconds - 9seconds
* Must meet the Biomicroscopic Criteria for both eyes as defined by the Oxford Grading Scale
* Generally good and stable …