Clinical trial NCT05857267: Dorzolamide+Timolol Multidose Preservative-free vs Dorzolamida+Timolol BAK Preserved Efficacy and Safety
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Glaucoma, Open-Angle
Ocular Hypertension
Lead sponsor: Laboratorios Poen
Sponsor class: INDUSTRY
First posted: 2023-05-12
Enrollment: 84
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Ocular Surface Disease Symptoms
timeFrame: Change from baseline in OSDI score at 24 weeks
Secondary outcomes:
measure: Intraocular preassure
timeFrame: Change from baseline in PIO (mmHg) at 24 weeks
measure: Break-up Time
timeFrame: Change from baseline BUT (seconds) at 24 weeks
measure: SCHIRMER-ITEST
timeFrame: Change from baseline Shirmer test (mm) at 24 weeks
measure: Conjunctival Hyperemia
timeFrame: Change from baseline in porcentaje of patients with conjunctival hyperemia at 24 weeks
measure: Satisfaction questionnaire
timeFrame: Change from baseline of patient satisfaction at 24 weeks using a 5-point likert scale
measure: Best corrected visual acuity
timeFrame: Change from baseline visual acuity at 24 weeks
measure: Treatment preference
timeFrame: Treatment preference with respect previous treatment at Week 24
Other outcomes:
measure: Superficial corneal epithelium density
timeFrame: Change from baseline superficial corneal epithelium density at 48 weeks
measure: Basal corneal epithelium density
timeFrame: Change from baseline basal corneal epithelium density at 48 weeks
measure: Corneal Estroma reflectivity
timeFrame: Change from baseline in the grade of corneal estroma reflectivity at 48 weeks specify by 4 grade scale reported by Martone et al. .
measure: Corneal nerve density
timeFrame: Change from baseline corneal nerve density at 48 weeks
measure: Neuroma density
timeFrame: Change from baseline neuroma density at 48 weeks
measure: Dendrite density
timeFrame: Change from baseline dendrite density at 48 weeks
measure: Corneal nerve tortuosity
timeFrame: Change from baseline in the grade of corneal nerve tortousity at 48 weeksusing a 5 point scale reported by Oliviera-Soto et al.
measure: Endothelial cell density
timeFrame: Change from baseline endothelial cell count at 48 weeks
measure: Conjuctival epithelium density
timeFrame: Change from baseline conjuctival epithelium density at 48 weeks
measure: Goblett cell density
timeFrame: Change from baseline goblett cell density at 48 weeks
measure: Inflamatory infiltrates
timeFrame: Change from baseline in inflamatory infiltrates at 48 weeks
Locations:
city: Olivos
country: Argentina
facility: Clínica de Ojos Dr. Nano
state: Buenos Aires
city: Ciudad Autonoma de Buenos Aire
country: Argentina
facility: Consultorio Dr. Peyret
state: Ciudad Autónoma De Buenos Aires
city: Ciudad Autonoma de Buenos Aire
country: Argentina
facility: Gonella Oftalmólogos
state: Ciudad Autónoma De Buenos Aires
city: Ciudad Autonoma de Buenos Aire
country: Argentina
facility: Centro Diagnóstico Dr. Gentile
state: Ciudad Autónoma De Buenos Aires
city: Ciudad Autónoma de Buenos Aire
country: Argentina
facility: Centro oftalmológico Dr. Casiraghi & asociados
state: Ciudad Autónoma De Buenos Aires
city: Ciudad autónoma de Buenos Aires
country: Argentina
facility: Consultorios de Oftalmología
Study officials:
References: