Back to resultsOcular Signs and Symptoms in Glaucoma Patients Switched From Latanoprost to Preservative Free Tafluprost Eye Drops
Primary Purpose
Ocular Hypertension, Open-Angle Glaucoma
Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
tafluprost
Sponsored by
About this trial
This is an interventional treatment trial for Ocular Hypertension
Eligibility Criteria
Inclusion Criteria:
- Patients with a diagnosis of ocular hypertension or open angle glaucoma for which the patient has been using latanoprost 0.005% as his/her prior medication.
- Evaluable patients must have ocular surface related symptoms and/or signs with their prior medication.
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Open-lable study with one arm
Arm Description
Outcomes
Primary Outcome Measures
Assessment of changes in ocular symptoms and signs
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
Secondary outcome measures include the assessment of safety and quality of life parameters.
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01087671
Brief Title
Ocular Signs and Symptoms in Glaucoma Patients Switched From Latanoprost to Preservative Free Tafluprost Eye Drops
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 Type
Interventional
2. Study Status
Record Verification Date
November 2010
Overall Recruitment Status
Completed
Study Start Date
April 2010 (undefined)
Primary Completion Date
October 2010 (Actual)
Study Completion Date
October 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Santen Oy
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to investigate if changes in ocular signs and symptoms occur in patients with ocular hypertension or glaucoma when they switch from latanoprost 0.005% (Xalatan) to preservative free Tafluprost eye drops.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ocular Hypertension, Open-Angle Glaucoma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
185 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Open-lable study with one arm
Arm Type
Other
Intervention Type
Drug
Intervention Name(s)
tafluprost
Intervention Description
prostaglandin analogue
Primary Outcome Measure Information:
Title
Assessment of changes in ocular symptoms and signs
Description
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).
Time Frame
From Screening (Visit 1) to12 weeks.
Secondary Outcome Measure Information:
Title
Secondary outcome measures include the assessment of safety and quality of life parameters.
Description
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.
Time Frame
From Screening (visit 1) to 12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients with a diagnosis of ocular hypertension or open angle glaucoma for which the patient has been using latanoprost 0.005% as his/her prior medication.
Evaluable patients must have ocular surface related symptoms and/or signs with their prior medication.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Evgeniy Egorov, Professor
Organizational Affiliation
State Educational Establishment of Higher Professional Education "Russian State Medical University of Federal Service on Surveillance in Healthcare and Social Development of Russian Federation"
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
Ocular Signs and Symptoms in Glaucoma Patients Switched From Latanoprost to Preservative Free Tafluprost Eye Drops
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