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24-hour Efficacy and Tolerability of the Tafluprost-timolol Fixed Association Without Preservatives in Glaucomatous or Ocular Hypertensive Patients Already Treated With Latanoprost Preserved With BAK. A Prospective, Open Study of 3 Months Duration.

NCT05299593 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 43

Last updated 2022-03-29

No results posted yet for this study

Summary

This is a phase IV, interventional, multi-center, open clinical Trial. Patients will be administered one eye drop of tafluprost/timolol fixed combination at 20:00 (+/- 1 hour), in the treatment of open angle glaucoma and ocular hypertension. The patients will suspend the treatment with latanoprost.

Conditions

Interventions

DRUG

tafluprost/timolol

One ml active drug contains: 15 micrograms of tafluprost and 5 mg of timolol (as maleate). A single-dose container (0.3 ml) of eye drops, solution, contains 4.5 micrograms of tafluprost and 1.5 mg of timolol. One drop (about 30 µl) contains about 0.45 micrograms of tafluprost and 0.15 mg of timolol. Patients will be administrered with one drop in the conjunctival sac of the affected eye (s) once a day.

Sponsors & Collaborators

  • Fondazione G.B. Bietti, IRCCS

    lead OTHER

Principal Investigators

  • Francesco Oddone, MD · IRCCS G.B.Bietti Foundation for the study and Research in Ophthalmology ONLUS

  • Luciano Quaranta, MD · Università di Pavia Policlinico S. Matteo

  • Luca Rossetti, MD · ASST Santi Paolo e Carlo

Study Design

Allocation
NA
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-06-04
Primary Completion
2022-06-30
Completion
2022-06-30

Countries

  • Italy

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05299593 on ClinicalTrials.gov