NCT01087671

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
185

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Apr 2010

Shorter than P25 for phase_3

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 3, 2010

Completed
13 days until next milestone

First Posted

Study publicly available on registry

March 16, 2010

Completed
16 days until next milestone

Study Start

First participant enrolled

April 1, 2010

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2010

Completed
Last Updated

May 31, 2013

Status Verified

November 1, 2010

Enrollment Period

6 months

First QC Date

March 3, 2010

Last Update Submit

May 30, 2013

Conditions

Ocular HypertensionOpen-Angle Glaucoma

Outcome Measures

Primary Outcomes (1)

  • 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.

Secondary Outcomes (1)

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

    From Screening (visit 1) to 12 weeks

Study Arms (1)

Open-lable study with one arm

OTHER
Drug: tafluprost

Interventions

tafluprostDRUG

prostaglandin analogue

Open-lable study with one arm

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Ocular HypertensionGlaucoma, Open-Angle

Interventions

tafluprost

Condition Hierarchy (Ancestors)

Eye DiseasesGlaucoma

Study Officials

  • 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"

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 3, 2010

First Posted

March 16, 2010

Study Start

April 1, 2010

Primary Completion

October 1, 2010

Study Completion

October 1, 2010

Last Updated

May 31, 2013

Record last verified: 2010-11