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

Sponsor

Santen Oy (Industry)

Overall Status

Completed

CT.gov ID

NCT01087671

Collaborator

(none)

185

Enrollment

Arm

Duration (Months)

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Ocular Hypertension Open-Angle Glaucoma	Drug: tafluprost	Phase 3

Study Design

Study Type:

Interventional

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 :

Apr 1, 2010

Actual Primary Completion Date :

Oct 1, 2010

Actual Study Completion Date :

Oct 1, 2010

Arms and Interventions

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

Arm

Intervention/Treatment

Other: Open-lable study with one arm

Drug: tafluprost

prostaglandin analogue

Outcome Measures

Primary Outcome Measures

Assessment of changes in ocular symptoms and signs [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

Secondary outcome measures include the assessment of safety and quality of life parameters. [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Santen Oy

Investigators

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"