Dorzolamide+Timolol Multidose Preservative-free vs Dorzolamida+Timolol BAK Preserved Efficacy and Safety

Phase 4

Completed

• Conditions: Ocular Hypertension; Glaucoma, Open-Angle
• Interventions: Drug: Dorzolamide / Timolol Ophthalmic Solution; Drug: dorzolamide/timolol

• Registration Number: NCT05857267
• Lead Sponsor: Laboratorios Poen

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-03-07
• Study First Submitted: 2023-03-30
• Study First Submitted QC: 2023-05-10
• Study First Posted: 2023-05-12
• Status Verified: 2024-11
• Primary Completion: 2024-11-04
• Study Completion: 2024-11-04
• Last Update Submitted: 2024-11-04
• Last Update Posted: 2024-11-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 84

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Dorzolamide+Timolol PF	Dorzolamide / Timolol Ophthalmic Solution	Glaucotensil TD LC, Laboratorios Poen
Dorzolamide + Timolol BAK	dorzolamide/timolol	Glaucotensil TD, Laboratorios Poen

Primary Outcome Measures

Name	Time	Method
Ocular Surface Disease Symptoms	Change from baseline in OSDI score at 24 weeks	OSDI questtionarie

Secondary Outcome Measures

Name	Time	Method
Intraocular preassure	Change from baseline in PIO (mmHg) at 24 weeks	Intraocular preassure (PIO) by GAT
Break-up Time	Change from baseline BUT (seconds) at 24 weeks	Break-up Time (BUT)
SCHIRMER-ITEST	Change from baseline Shirmer test (mm) at 24 weeks	Schirmer test without anesthesia
Treatment preference	Treatment preference with respect previous treatment at Week 24	Treatment preference
Satisfaction questionnaire	Change from baseline of patient satisfaction at 24 weeks using a 5-point likert scale	Satisfaction questionnaire
Conjunctival Hyperemia	Change from baseline in porcentaje of patients with conjunctival hyperemia at 24 weeks	Conjunctival Hyperemia
Best corrected visual acuity	Change from baseline visual acuity at 24 weeks	snellen scale 20/20

Trial Locations

Locations (6)

Gonella Oftalmólogos; 🇦🇷 Ciudad Autonoma de Buenos Aire, Ciudad Autónoma De Buenos Aires, Argentina

Clínica de Ojos Dr. Nano; 🇦🇷 Olivos, Buenos Aires, Argentina

Centro Diagnóstico Dr. Gentile; 🇦🇷 Ciudad Autonoma de Buenos Aire, Ciudad Autónoma De Buenos Aires, Argentina

Consultorio Dr. Peyret; 🇦🇷 Ciudad Autonoma de Buenos Aire, Ciudad Autónoma De Buenos Aires, Argentina

Centro oftalmológico Dr. Casiraghi & asociados; 🇦🇷 Ciudad Autónoma de Buenos Aire, Ciudad Autónoma De Buenos Aires, Argentina

Consultorios de Oftalmología; 🇦🇷 Ciudad autónoma de Buenos Aires, Argentina