Phase IV, Multicenter, Double-blind, Randomized, Controlled, Parallel-group, Trial to Evaluate the Efficacy and Safety of Dozolamide 2%/Timolol 0,5% PF vs Dorzolamide 2%/Timolol 0,5% BAK-preserved in OAG or OH

CompletadoFase 4ClinicalTrials.gov

ID: NCT05857267Tipo: INTERVENTIONALInicio: 7 de mar de 2023Fin estimado: 4 de nov de 2024

Traducción no disponible, mostrando original

Resumen

The goal of this study is to evaluate the tolerability of the new formulation of Dorzolamide+Timolol preservative free developed in OSD Aptar Pharma multidose system in comparison with Dorzolamide +Timolol BAK preserved ophthalmic formulation.

Elegibilidad

Edad mínima: 18 YearsSexo: ALL

Criterios de inclusión

Older than 18 years old
Patients with POAG and OH
PIO \< 20 mmHg
Under treatment with Dorzolamide + Timolol BAK preserved at least 6 month after
OSDI \> 13 \& one of these ocular signs (BUT \<6sec or Schirmer test \< 5 mm/5min or corneal staining positive)
Corneal thickness between 520-580 um.

Criterios de exclusión

Patient with severe respiratory diseases (asthma, COPD and other bronchospactic diseases).
Patient with cardiovascular diseases (Sinus Bradycardia, AV Block, Cardiac Failure, Cardiogenic Shock).
Severe renal impairment (CrCl \<30 mL/min)
Progressive diseases of the retina other than glaucoma
Inflammation and/or infecctions active
Ocular surface syndrome other than Ocular Surface disease
Eyelid disorder
Systemic adminsitration of Betablockers or carbonic anhydrase inhibitors
Patient that requires another antigluacomatous eye drop other than fixed combination of Dorzolamide/Timolol
Patients who use regularly lubricant eye drops
Patient who use regularly contact lenses
Patient with autoinmune diseases
Patients who underwent kerato-refractive laser procedures, cornea or corneal surface surgery, including, but not limited to, LASIK and PRK, within 6 months prior to the baseline visit.
Patients who have undergone a laser procedure or intraocular surgery or extraocular in either eye within 6 months prior to the baseline visit.
Patients with severe central visual field loss in either eye based onclinical judgment of the investigator. For the Humphrey and Octopus perimeters, the severe loss The visual field is defined as a sensitivity less than or equal to 10 dB in at least two(2) of the four (4) visual field test points closest to the fixation point
Patients with known hypersensitivity to any of the components of bothdrugs under study.
Pregnant or lactating women.
Women of childbearing age who are not using a contraceptive method.

Intervenciones

drug

Dorzolamide / Timolol Ophthalmic Solution

Dorzolamide-timolol fixed combination in a preservative-free multidose device

drug

dorzolamide/timolol

Dorzolamide-timolol BAK-preserved fixed combination

Ubicaciones

Clínica de Ojos Dr. Nano

Olivos, Buenos Aires, Argentina

Consultorio Dr. Peyret

Ciudad Autonoma de Buenos Aire, Buenos Aires F.D., Argentina

Gonella Oftalmólogos

Ciudad Autonoma de Buenos Aire, Buenos Aires F.D., Argentina

Centro Diagnóstico Dr. Gentile

Ciudad Autonoma de Buenos Aire, Buenos Aires F.D., Argentina

Centro oftalmológico Dr. Casiraghi & asociados

Ciudad Autónoma de Buenos Aire, Buenos Aires F.D., Argentina

Consultorios de Oftalmología

Buenos Aires, Argentina

Patrocinadores

PrincipalLaboratorios Poen

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