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 | Unknown Phase 4 DMC

• 1 other identifier: HERO
• Study Type: interventional
• Target: 43
• Locations: 1 country
• Sites: 3

Brief 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

Glaucoma, Open-Angle; Ocular Hypertension

Keywords

Glaucoma, ocular hypertension

Outcome Measures

Primary Outcomes (1)

• The evaluation of the mean 24-h absolute Intraocular Pressure (IOP)

  Reduction measured in mmHg (millimeters of mercury).

  through study completion, an average of 3 months

Secondary Outcomes (9)

• Evaluation of the average reduction of Intraocular Pressure(IOP) at 24-hour

  through study completion, an average of 3 months

• Evaluation of the percentage reduction of the average Intraocular Pressure(IOP) of the 24 hours

  through study completion, an average of 3 months

• Evaluation of the average daytime reduction and night of the Intraocular Pressure(IOP)

  through study completion, an average of 3 months

• Evaluation of the percentage of patients achieving Intraocular Pressure(IOP) reduction in average

  through study completion, an average of 3 months

• Evaluation of the changes in the Corneale Staining Test (CFS) and Break-up Time Test (tBUT) parameters

  through study completion, an average of 3 months

Study Arms (1)

tafluprost/timolol

EXPERIMENTAL

Enrolled patients will be treated with one drop of the fixed combination Tafluprost-Thymol without preservative in the evening at 20.00 (+/- 1 hour). Patients will be administrered with one drop in the conjunctival sac of the affected eye (s) once a day.

Drug: tafluprost/timolol

Interventions

tafluprost/timolol DRUG

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.

tafluprost/timolol

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Ocular hypertension or primary open-angle glaucoma or secondary to dispersion of pigment or pseudoesfoliatio;
• IOP \<22 mmHg in latanoprost therapy in both eyes since at least 6 weeks and \> 17 mmHg in at least one eye;
• OSD at least mild as defined by DEQ-5 (score\> 6);
• Examination of the visual field during the three months prior to enrollment (if not present, the patient must be subjected to a visual field at the screening visit);
• Treatment with latanoprost BAK-preserved from at least 6 weeks;
• Subject agrees to follow the study procedures and signs the EC-approved ICF;
• For women of child-bearing potential, blood screening for beta-HCG before randomization and use of one effective method of birth control during the conduct of the study

You may not qualify if:

• Inability to understand and sign informed consent;
• Age under 18 years;
• Other forms of secondary glaucoma (besides pigmentary and pseudoesfoliatius);
• Narrow angle or history of acute glaucoma attacks;
• Previous history of trabeculoplasty in the previous 6 months;
• History of glaucoma surgery or refractive surgery;
• Cataract surgery in the 6 months prior to enrollment;
• Contraindications to the use of beta-blockers (reactive airway disease, including bronchial asthma or a history of bronchial asthma, severe chronic obstructive pulmonary disease; sinus bradycardia, sick sinus syndrome, including sinoatrial block, second or third degree atrioventricular block not controlled by pacemaker; full-blown heart failure, cardiogenic shock);
• Damage to the visual field with a mean deviation (MD) \<-20 dB;
• BCVA \<2/10;
• Topical ocular drugs performed within 3 months prior to enrollment that may interfere with the study results (eg steroids, non-steroidal anti-inflammatory drugs, immunosuppressants, etc.);
• Use of tear substitutes containing preservatives within 30 days prior to enrollment;
• Any other condition that, in the opinion of the investigator, may compromise the safety or compliance of the patient or would preclude the patient from successful completion of the study or would impair interpretation of results;
• Corneal anomalies that preclude an accurate measurement of IOP (eg astigmatism\> 3 D, keratoconus, opacity or corneal ulcers);
• Any type of previous corneal or conjunctival surgery including pterygium removal or refractive surgery;

Sponsors & Collaborators

• Fondazione G.B. Bietti, IRCCS: lead

Study Sites (3)

ASST Santi Paolo e Carlo

Milan, 20142, Italy

RECRUITING

Università di Pavia Policlinico S. Matteo

Pavia, 27100, Italy

NOT YET RECRUITING

IRCCS G.B.Bietti Foundation for the study and Research in Ophthalmology ONLUS

Roma, 00198, Italy

RECRUITING

MeSH Terms

Conditions

Glaucoma, Open-Angle; Ocular Hypertension; Glaucoma

Interventions

tafluprost; Timolol

Condition Hierarchy (Ancestors)

Eye Diseases

Intervention Hierarchy (Ancestors)

Propanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Propanols; Amines; Thiadiazoles; Thiazoles; Sulfur Compounds; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Morpholines; Oxazines

Study Officials

• Francesco Oddone, MD

  IRCCS G.B.Bietti Foundation for the study and Research in Ophthalmology ONLUS

  PRINCIPAL INVESTIGATOR

• Luciano Quaranta, MD

  Università di Pavia Policlinico S. Matteo

  PRINCIPAL INVESTIGATOR

• Luca Rossetti, MD

  ASST Santi Paolo e Carlo

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Francesco Oddone, MD

CONTACT

0685356727; francesco.oddone@fondazionebietti.it

Lucia Tanga, MD

CONTACT

3381177456; lucia.tanga@fondazionebietti.it

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Masking Details: Open label
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Single group, open label

Study Record Dates

• First Submitted: February 15, 2022
• First Posted: March 29, 2022
• Study Start: June 4, 2020
• Primary Completion: June 30, 2022
• Study Completion: June 30, 2022
• Last Updated: March 29, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share

Locations

IT (3)