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The advantage of the transition from conservative therapy not preserved in glaucoma. Clinical study and confocal.

(The advantage of choosing from preserved to preserved-free treatments for glaucoma. A clinical and confocal study) - MSD-007

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2011-004617-16-IT
Enrollment
40
Registered
2012-01-16
Start date
2011-11-21
Completion date
Unknown
Last updated
2025-01-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

glaucoma

Interventions

Trade Name: SAFLUTAN*COLL30FL 15MCG/ML 0,3 Pharmaceutical Form: Eye drops INN or Proposed INN: TAFLUPROST Current Sponsor code: Tafluprost Concentration unit: µg/ml microgram(s)/millilitre Concentrati

Sponsors

AZIENDA OSPEDALIERA S. PAOLO (A.O. DI RILIEVO NAZIONALE)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: NEW DIAGNOSIS OF GLAUCOMA Are the trial subjects under 18? no Number of subjects for this age range: 0 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 25 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 15

Exclusion criteria

Exclusion criteria: CORNEAL PATHOLOGIES DIABETES AT ANY STAGES, HISTORY OF ACUTEANGLE CLOSURE GLAUCOMA.

Design outcomes

Primary

MeasureTime frame
Main Objective: EVALUATE CHANGES INDUCED BY TWO DRUGS ON OCULAR SURFACE IN PATIENTS WITH A NEW DIAGNOSIS OF GLAUCOMA;Secondary Objective: NO;Primary end point(s): COMPAIRE THE CONFOCAL NERVE FIBER LAYER DENSITY OF THE CORNEA IN THE FOUR LIMBAR REGIONS IN THE TWO ARMS STUDIES;Timepoint(s) of evaluation of this end point: 12 MESI

Secondary

MeasureTime frame
Secondary end point(s): NO;Timepoint(s) of evaluation of this end point: NO

Countries

Italy

Contacts

Public ContactU.O. di Oculistica

AZIENDA OSPEDALIERA S. PAOLO

luca.rossetti@unimi.it02-50323150

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026