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Ocular Signs and Symptoms in Glaucoma Patients Switched From Latanoprost to Preservative Free Tafluprost Eye Drops

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ClinicalTrials.gov Identifier: NCT01087671
Recruitment Status : Completed
First Posted : March 16, 2010
Last Update Posted : May 31, 2013
Sponsor:
Information provided by (Responsible Party):
Santen Oy

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.

Condition or disease Intervention/treatment Phase
Ocular Hypertension Open-Angle Glaucoma Drug: tafluprost Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 185 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Glaucoma
Drug Information available for: Tafluprost

Arm Intervention/treatment
Open-lable study with one arm Drug: tafluprost
prostaglandin analogue




Primary Outcome Measures :
  1. 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 :
  1. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

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


Sponsors and Collaborators
Santen Oy
Investigators
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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"
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Responsible Party: Santen Oy
ClinicalTrials.gov Identifier: NCT01087671    
Other Study ID Numbers: 77553
First Posted: March 16, 2010    Key Record Dates
Last Update Posted: May 31, 2013
Last Verified: November 2010
Additional relevant MeSH terms:
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Glaucoma
Glaucoma, Open-Angle
Ocular Hypertension
Hypertension
Vascular Diseases
Cardiovascular Diseases
Eye Diseases