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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
84
Dorzolamide-timolol fixed combination in a preservative-free multidose device
Dorzolamide-timolol BAK-preserved fixed combination
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
Ocular Surface Disease Symptoms
OSDI questtionarie
Time frame: Change from baseline in OSDI score at 24 weeks
Intraocular preassure
Intraocular preassure (PIO) by GAT
Time frame: Change from baseline in PIO (mmHg) at 24 weeks
Break-up Time
Break-up Time (BUT)
Time frame: Change from baseline BUT (seconds) at 24 weeks
SCHIRMER-ITEST
Schirmer test without anesthesia
Time frame: Change from baseline Shirmer test (mm) at 24 weeks
Conjunctival Hyperemia
Conjunctival Hyperemia
Time frame: Change from baseline in porcentaje of patients with conjunctival hyperemia at 24 weeks
Satisfaction questionnaire
Satisfaction questionnaire
Time frame: Change from baseline of patient satisfaction at 24 weeks using a 5-point likert scale
Best corrected visual acuity
snellen scale 20/20
Time frame: Change from baseline visual acuity at 24 weeks
Treatment preference
Treatment preference
Time frame: Treatment preference with respect previous treatment at Week 24
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Centro oftalmológico Dr. Casiraghi & asociados
Ciudad Autónoma de Buenos Aire, Buenos Aires F.D., Argentina
Consultorios de Oftalmología
Buenos Aires, Argentina