NCT01433900

Brief Summary

A 1-year prospective, randomized, investigator-masked trial comparing the confocal and clinical effects of treatment with unpreserved prostaglandins (tafluprost) versus preserved prostaglandins (latanoprost) in newly-diagnosed glaucoma patients.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started May 2012

Geographic Reach
1 country

1 active site

Status
unknown

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

July 25, 2011

Completed
2 months until next milestone

First Posted

Study publicly available on registry

September 14, 2011

Completed
8 months until next milestone

Study Start

First participant enrolled

May 1, 2012

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2013

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2014

Completed
Last Updated

May 16, 2014

Status Verified

September 1, 2011

Enrollment Period

1 year

First QC Date

July 25, 2011

Last Update Submit

May 15, 2014

Conditions

Glaucoma

Keywords

glaucomaintraocular pressureocular surfacebenzalkonium chloride

Outcome Measures

Primary Outcomes (1)

  • Changes in the difference in the fiber density of the subbasal nerves in the central cornea and in each of 4 limbal quadrants

    Month 3, 6, 9, 12

Secondary Outcomes (3)

  • Changes in sub-basal nerve characteristics (reflectivity, beading, tortuosity)

    Months 3, 6, 9 ,12

  • Changes in density of epithelial cells, Langerhans cells, endothelial cells

    Month 3, 6, 9 ,12

  • Changes in ocular surface (symptom and sign scales, break-up time, Schirmer test)

    Month 3, 6, 9, 12

Study Arms (2)

Tafluprost

ACTIVE COMPARATOR

1 drop of tafluprost to eligible eye(s) once daily (at 9 pm)

Drug: Tafluprost

Latanoprost

ACTIVE COMPARATOR

1 drop of latanoprost to eligible eye(s) once daily (at 9 pm)

Drug: Latanoprost

Interventions

TafluprostDRUG

1 drop of tafluprost to eligible eye(s) once daily (at 9 pm)

Tafluprost
LatanoprostDRUG

1 drop of tafluprost to eligible eye(s) once daily (at 9 pm)

Latanoprost

Eligibility Criteria

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

You may qualify if:

  • The patient is suffering from ocular hypertension, POAG, PEX, NTG. Glaucoma definition is based on the European Glaucoma Society Guidelines.
  • The patient is newly-diagnosed
  • No fluorescein staining at baseline and no observable signs of ocular surface disease
  • No treatment with topical BAK-containing products for at least 6 months
  • Treatment of naïve patients

You may not qualify if:

  • Unwilling to sign informed consent
  • Not at least 18 years old
  • Ocular condition that are of safety concern and that can interfere with the study results
  • Closed/barely open anterior chamber angles or history of acute angle closure.
  • Ocular surgery or argon laser trabeculoplasty within the last year. Ocular inflammation/infection occurring within three months prior to pre-trial visit.
  • Presence of the following ocular conditions: KCS, moderate-severe blepharitis, Rosacea, Sjogren syndrome, pterygium, contact lens users.
  • Use of concomitant topical ocular medication that can interfere with study medication
  • Hypersensitivity to benzalkonium chloride or to any other component of the trial drug solutions.
  • Any corneal pathology
  • Diabetes at any stage
  • Other abnormal condition or symptom preventing the patient from entering the trial, according to the Investigator's judgement.
  • Refractive surgery patients
  • Women who are pregnant, are of childbearing potential and are not using adequate contraception or are nursing.
  • Inability to adhere to treatment/visit plan.
  • Have participated in any other clinical trial (i.e., requiring informed consent) within one to three month prior to pre-trial visit (depending on ethics committee decisions).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

San Paolo Hospital

Milan, 20142, Italy

RECRUITING

Related Publications (1)

  • Fogagnolo P, Dipinto A, Vanzulli E, Maggiolo E, De Cilla' S, Autelitano A, Rossetti L. A 1-year randomized study of the clinical and confocal effects of tafluprost and latanoprost in newly diagnosed glaucoma patients. Adv Ther. 2015 Apr;32(4):356-69. doi: 10.1007/s12325-015-0205-5. Epub 2015 Apr 19.

    PMID: 25893514DERIVED

MeSH Terms

Conditions

Glaucoma

Interventions

tafluprostLatanoprost

Condition Hierarchy (Ancestors)

Ocular HypertensionEye Diseases

Intervention Hierarchy (Ancestors)

Prostaglandins F, SyntheticProstaglandins, SyntheticProstaglandinsEicosanoidsFatty Acids, UnsaturatedFatty AcidsLipidsAutacoidsInflammation MediatorsBiological Factors

Study Officials

  • Luca Rossetti, MD

    San Paolo Hospital, Milan, Italy

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Luca Rossetti, MD

CONTACT

+390281844401luca.rossetti@unimi.it

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Prof. Luca Rossetti

Study Record Dates

First Submitted

July 25, 2011

First Posted

September 14, 2011

Study Start

May 1, 2012

Primary Completion

May 1, 2013

Study Completion

June 1, 2014

Last Updated

May 16, 2014

Record last verified: 2011-09

Locations

IT(1)