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

Ocular Hypertension Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05857267
• Other study ID #: ANTIGLAULC01
• Status: Recruiting
• Phase: Phase 4
• Start date: March 7, 2023
• Est. completion date: November 15, 2024

Study information

• Verified date: April 2024
• Source: Laboratorios Poen
• Contact: Melina del Papa
• Phone: 01160480067
• Email: mdelpapa[@]poen.net.ar
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 84
• Est. completion date: November 15, 2024
• Est. primary completion date: October 4, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Glaucoma, Open-Angle
• Ocular Hypertension

Intervention

Drug:
• Dorzolamide / Timolol Ophthalmic Solution
Dorzolamide-timolol fixed combination in a preservative-free multidose device
• dorzolamide/timolol
Dorzolamide-timolol BAK-preserved fixed combination

Locations

Country	Name	City	State
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	Gonella Oftalmólogos	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	Clínica de Ojos Dr. Nano	Olivos	Buenos Aires

Sponsors (1)

Lead Sponsor	Collaborator
Laboratorios Poen

Country where clinical trial is conducted

Argentina, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Superficial corneal epithelium density	Superficial corneal epithelium density analyzed by confocal microscopy expresed by cells /mm2	Change from baseline superficial corneal epithelium density at 48 weeks
Other	Basal corneal epithelium density	Basal corneal epithelium density analyzed by confocal microscopy expresed by cells /mm2	Change from baseline basal corneal epithelium density at 48 weeks
Other	Corneal Estroma reflectivity	Corneal Estroma reflectivity analyzed by confocal microscopy expresed by 5-point scale of grade	Change from baseline in the grade of corneal estroma reflectivity at 48 weeks specify by 4 grade scale reported by Martone et al. .
Other	Corneal nerve density	Corneal nerve density analyzed by confocal microscopy expresed by cells /mm2	Change from baseline corneal nerve density at 48 weeks
Other	Neuroma density	Neuroma density analyzed by confocal microscopy expresed by neuromas/mm2	Change from baseline neuroma density at 48 weeks
Other	Dendrite density	Dendrite density analyzed by confocal microscopy expresed by dendrites/mm2	Change from baseline dendrite density at 48 weeks
Other	Corneal nerve tortuosity	Corneal nerve tortuosity analyzed by confocal microscopy expresed by 5-point scale of grade	Change from baseline in the grade of corneal nerve tortousity at 48 weeksusing a 5 point scale reported by Oliviera-Soto et al.
Other	Endothelial cell density	endothelial cell density analyzed by confocal microscopy expresed by cells/mm2	Change from baseline endothelial cell count at 48 weeks
Other	Conjuctival epithelium density	Conjuntival epithelium density analyzed by confocal microscopy expresed by cells/mm2	Change from baseline conjuctival epithelium density at 48 weeks
Other	Goblett cell density	Goblett cell density nalyzed by confocal microscopy expresed by cells/mm2	Change from baseline goblett cell density at 48 weeks
Other	Inflamatory infiltrates	Description of presence or absence of inflamtory cells on conjuntiva	Change from baseline in inflamatory infiltrates at 48 weeks
Primary	Ocular Surface Disease Symptoms	OSDI questtionarie	Change from baseline in OSDI score at 24 weeks
Secondary	Intraocular preassure	Intraocular preassure (PIO) by GAT	Change from baseline in PIO (mmHg) at 24 weeks
Secondary	Break-up Time	Break-up Time (BUT)	Change from baseline BUT (seconds) at 24 weeks
Secondary	SCHIRMER-ITEST	Schirmer test without anesthesia	Change from baseline Shirmer test (mm) at 24 weeks
Secondary	Conjunctival Hyperemia	Conjunctival Hyperemia	Change from baseline in porcentaje of patients with conjunctival hyperemia at 24 weeks
Secondary	Satisfaction questionnaire	Satisfaction questionnaire	Change from baseline of patient satisfaction at 24 weeks using a 5-point likert scale
Secondary	Best corrected visual acuity	snellen scale 20/20	Change from baseline visual acuity at 24 weeks
Secondary	Treatment preference	Treatment preference	Treatment preference with respect previous treatment at Week 24