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NCT01087671 Clinical Trial

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

Ocular Hypertension Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01087671
Other study ID # 77553
Secondary ID
Status Completed
Phase Phase 3
First received March 3, 2010
Last updated May 30, 2013
Start date April 2010
Est. completion date October 2010

Study information
Verified date November 2010
Source Santen Oy
Contact n/a
Is FDA regulated No
Health authority Russia: Ministry of Health of the Russian Federation
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 185
Est. completion date October 2010
Est. primary completion date October 2010
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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.

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• tafluprost
prostaglandin analogue

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Santen Oy

Outcome
Type Measure Description Time frame Safety issue
Primary 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).		 From Screening (Visit 1) to12 weeks. No
Secondary 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. From Screening (visit 1) to 12 weeks No
See also
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