3-months study to evaluate the efficacy and tolerability of the drug tafluprost –timolol without preservatives in people with glaucoma or high pressure in the eyes that have already taken latanoprost with preservative.

Phase 1

• Conditions: Glaucoma or ocular hypertension; MedDRA version: 20.0Level: HLGTClassification code 10018307Term: Glaucoma and ocular hypertensionSystem Organ Class: 10015919 - Eye disorders; Therapeutic area: Diseases [C] - Eye Diseases [C11]

• Registration Number: EUCTR2019-003426-24-IT
• Lead Sponsor: IRCCS FONDAZIONE G.B. BIETTI PER LO STUDIO E LA RICERCA IN OFTALMOLOGIA ONLUS

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-07-30
• Last Update Posted: 3 August 2020

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 43

Inclusion Criteria

1.Ocular hypertension or primary open-angle glaucoma or secondary to dispersion of pigment or pseudoesfoliatio;
2.IOP <22 mmHg in latanoprost therapy in both eyes and> 17 mmHg in at least one eye;
3.OSD at least mild as defined by DEQ-5 (score> 6);
4.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);
5.Treatment with latanoprost BAK-preserved from at least 6 weeks;
6.Subject agrees to follow the study procedures and signs the EC-approved ICF;
7.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
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 20
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 22

Exclusion Criteria

1.Inability to understand and sign informed consent;
2.Age under 18 years;
3.Other forms of secondary glaucoma (besides pigmentary and pseudoesfoliatius);
4.Narrow angle or history of acute glaucoma attacks;
5.Previous history of trabeculoplasty in the previous 6 months;
6.History of glaucoma surgery or refractive surgery;
7.Cataract surgery in the 6 months prior to enrollment;
8.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);
9.Damage to the visual field with a mean deviation (MD) <-20 dB;
10.BCVA <2/10;
11.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.);
12.Use of tear substitutes containing preservatives within 30 days prior to enrollment;
13.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;
14.Corneal anomalies that preclude an accurate measurement of IOP (eg astigmatism> 3 D, keratoconus, opacity or corneal ulcers);
15.Any type of previous corneal or conjunctival surgery including pterygium removal or refractive surgery;
16.Unstable systemic disorders that may require the initiation or variation of therapies that may influence intraocular pressure during the study;
17.Woman of childbearing potential, or who is currently pregnant or breastfeeding;
18.Inability to adhere to the procedures required by the protocol or to the studio treatment;
19.Participation in another experimental therapeutic protocol within one month prior to baseline and during the study period (participation in natural history study is allowed);
20.Hypersensitivity to the active substances or to any of the excipients.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified