Ocular Hypertension Clinical Trial
Official title:
A Phase III, Randomized, Double-masked 6-month Trial to Compare the Efficacy and Safety of the Preservative-free Fixed-dose Combination of Tafluprost and Timolol Eye Drops to Those of Tafluprost and Timolol Eye Drops Given Concomitantly in Patients With Open Angle Glaucoma or Ocular Hypertension
The purpose of this study is to compare the efficacy and safety of the preservative-free
fixed-dose combination of tafluprost and timolol (FDC) to concomitant administration of
tafluprost and timolol.
This study will enroll patients who have ocular hypertension or glaucoma.
The study schedule includes seven visits to the study site and three stages:
- washout of 5 days to 4 weeks depending on current glaucoma medication (if any)
- 6-month study treatment period
- 1-3 weeks post-study period
n/a
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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