Glaucoma or ocular hypertension MedDRA version: 20.0 Level: HLGT Classification code 10018307 Term: Glaucoma and ocular hypertension System Organ Class: 10015919 - Eye disorders
Conditions
Interventions
Trade Name: LOYADA - "15 MICROGRAMMI/ML + 5 MG/ML COLLIRIO, SOLUZIONE" 30 X 0,3ML CONTENITORI MONODOSE IN LDPE
Product Name: Loyada
Product Code: [N/A]
Pharmaceutical Form: Eye drops, solution
INN or
Sponsors
IRCCS FONDAZIONE G.B. BIETTI PER LO STUDIO E LA RICERCA IN OFTALMOLOGIA ONLUS
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Ocular hypertension or primary open-angle glaucoma or secondary to dispersion of pigment or pseudoesfoliatio; 2. IOP 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
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) 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective is to evaluate the effectiveness in reducing the mean 24-hour IOP of the preservative-free fixed combination of Tafluprost 0.0015% and Timolol 0.5% administered once at night (8pm) in POAG or OHT patients suffering from mild OSD and requiring further IOP reduction while in topical treatment with BAK-preserved Latanoprost 0.05 mg/ml.;Secondary Objective: 1) The reduction of IOP at each time of the 24-hour curve; 2) The value of the reduction of the IOP of the 24 hours and at each time point; 3) Daytime reduction and night of the IOP; 4) Patients achieving IOP reductions in average IOP of 24h; 5) Changes in the damage to the cornea and of the dry eye disease; 6) Changes of the dry eye disease; 7) Change in number and activation of corneal and conjunctival dendritic involved in the production of the lachrymal film; 8) Change in the number of conjunctival goblet cells involved in the production of the lachrymal film 9) Changes in quality of life.;Primary end point(s): The primary endpoint will be the evaluation of the mean 24-h absolute IOP reduction measured in mmHg (millimeters of mercury) from baseline to V3B.;Timepoint(s) of evaluation of this end point: Baseline and V3B | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1) Evaluation of the average reduction of IOP at each time of the 24-hour curve measured in mmHg (millimeters of mercury) at V3B compared with the 24-hour curve at baseline. 2) Evaluation of the percentage reduction of the average IOP of the 24 hours and at each time point to the V3B compared to the baseline. 3) Evaluation of the average daytime reduction (8:00, 11:00, 14:00, 17:00, 20:00) and night (23:00, 02:00, 05:00) of the IOP measured in mmHg (millimeters of mercury) to V3B compared to baseline. 4) Evaluation of the percentage of patients achieving IOP reductions in average IOP of 24h> 20%,> 25%,> 30% to V3B compared to baseline. 5) Evaluation of the changes in the CFS and tBUT parameters to V3A from baseline, respectively measured by extension of the area of the cornea colored by fluorescein and density of the staining, and the breaking time of the lachrymal film after staining with fluorescein 6) Evaluation of the changes in the Five-item dry eye (DEQ-5) questionnaire to V3A from baseline measured by the score assigned to the questions. 7) Evaluation of the changes of the number and activation of corneal and conjunctival dendritic cells to confocal microscopy to V3A from baseline 8) Evaluation of the changes of the number of conjunctival goblet cells to confocal microscopy compared to V3A from baseline.;Timepoint(s) of evaluation of this end point: 1), 2), 3), 4): baseline and V3B 5), 6), 7), 8): baseline and V3A | — |
Countries
Italy
Contacts
Public ContactClinical Operations
Link Neuroscience and Health Care srl - L.N.Age srl
Outcome results
None listed