Ocular Signs and Symptoms in Glaucoma Patients Switched From Latanoprost to Preservative Free Tafluprost Eye Drops
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01087671|
Recruitment Status : Completed
First Posted : March 16, 2010
Last Update Posted : May 31, 2013
|Condition or disease||Intervention/treatment||Phase|
|Ocular Hypertension Open-Angle Glaucoma||Drug: tafluprost||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||185 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Ocular Signs and Symptoms in Patients With Ocular Hypertension or Open-angle Glaucoma Switched From Preserved Latanoprost 0.005% Eye Drops to Preservative Free Tafluprost Eye Drops|
|Study Start Date :||April 2010|
|Actual Primary Completion Date :||October 2010|
|Actual Study Completion Date :||October 2010|
|Open-lable study with one arm||
- Assessment of changes in ocular symptoms and signs [ Time Frame: From Screening (Visit 1) to12 weeks. ]
Ocular symptoms include: irritation/burning/stinging, foreign body sensation, tearing, itching and dry eye sensation.
Following signs will be evaluated: tear break-up time, corneal and conjunctival fluorescein staining, blepharitis, conjunctival redness and tear secretion (schirmer test).
- Secondary outcome measures include the assessment of safety and quality of life parameters. [ Time Frame: From Screening (visit 1) to 12 weeks ]Safety parameters include: best-corrected visual acuity, biomicroscopy, ophthalmoscopy, visual field test, drop discomfort upon instillation, intra ocular pressure, quality of life and adverse events.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01087671
|Principal Investigator:||Evgeniy Egorov, Professor||State Educational Establishment of Higher Professional Education "Russian State Medical University of Federal Service on Surveillance in Healthcare and Social Development of Russian Federation"|