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

Primary Purpose

Glaucoma, Open-Angle, Ocular Hypertension

Status
Recruiting
Phase
Phase 4
Locations
Argentina
Study Type
Interventional
Intervention
Dorzolamide / Timolol Ophthalmic Solution
dorzolamide/timolol
Sponsored by
Laboratorios Poen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Glaucoma, Open-Angle

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Clínica de Ojos Dr. NanoRecruiting
  • Consultorio Dr. Peyret
  • Gonella OftalmólogosRecruiting
  • Centro Diagnóstico Dr. Gentile
  • Centro oftalmológico Dr. Casiraghi & asociados
  • Consultorios de Oftalmología

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Dorzolamide+Timolol PF

Dorzolamide + Timolol BAK

Arm Description

Glaucotensil TD LC, Laboratorios Poen

Glaucotensil TD, Laboratorios Poen

Outcomes

Primary Outcome Measures

Ocular Surface Disease Symptoms
OSDI questtionarie

Secondary Outcome Measures

Intraocular preassure
Intraocular preassure (PIO) by GAT
Break-up Time
Break-up Time (BUT)
SCHIRMER-ITEST
Schirmer test without anesthesia
Conjunctival Hyperemia
Conjunctival Hyperemia
Satisfaction questionnaire
Satisfaction questionnaire
Best corrected visual acuity
snellen scale 20/20
Treatment preference
Treatment preference

Full Information

First Posted
March 30, 2023
Last Updated
May 10, 2023
Sponsor
Laboratorios Poen
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1. Study Identification

Unique Protocol Identification Number
NCT05857267
Brief Title
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

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 7, 2023 (Actual)
Primary Completion Date
March 15, 2024 (Anticipated)
Study Completion Date
September 15, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Laboratorios Poen

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glaucoma, Open-Angle, Ocular Hypertension

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
84 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Dorzolamide+Timolol PF
Arm Type
Experimental
Arm Description
Glaucotensil TD LC, Laboratorios Poen
Arm Title
Dorzolamide + Timolol BAK
Arm Type
Experimental
Arm Description
Glaucotensil TD, Laboratorios Poen
Intervention Type
Drug
Intervention Name(s)
Dorzolamide / Timolol Ophthalmic Solution
Other Intervention Name(s)
Glaucotensil TD LC
Intervention Description
Dorzolamide-timolol fixed combination in a preservative-free multidose device
Intervention Type
Drug
Intervention Name(s)
dorzolamide/timolol
Other Intervention Name(s)
Glaucotensil TD
Intervention Description
Dorzolamide-timolol BAK-preserved fixed combination
Primary Outcome Measure Information:
Title
Ocular Surface Disease Symptoms
Description
OSDI questtionarie
Time Frame
Change from baseline in OSDI score at 24 weeks
Secondary Outcome Measure Information:
Title
Intraocular preassure
Description
Intraocular preassure (PIO) by GAT
Time Frame
Change from baseline in PIO (mmHg) at 24 weeks
Title
Break-up Time
Description
Break-up Time (BUT)
Time Frame
Change from baseline BUT (seconds) at 24 weeks
Title
SCHIRMER-ITEST
Description
Schirmer test without anesthesia
Time Frame
Change from baseline Shirmer test (mm) at 24 weeks
Title
Conjunctival Hyperemia
Description
Conjunctival Hyperemia
Time Frame
Change from baseline in porcentaje of patients with conjunctival hyperemia at 24 weeks
Title
Satisfaction questionnaire
Description
Satisfaction questionnaire
Time Frame
Change from baseline of patient satisfaction at 24 weeks using a 5-point likert scale
Title
Best corrected visual acuity
Description
snellen scale 20/20
Time Frame
Change from baseline visual acuity at 24 weeks
Title
Treatment preference
Description
Treatment preference
Time Frame
Treatment preference with respect previous treatment at Week 24
Other Pre-specified Outcome Measures:
Title
Superficial corneal epithelium density
Description
Superficial corneal epithelium density analyzed by confocal microscopy expresed by cells /mm2
Time Frame
Change from baseline superficial corneal epithelium density at 48 weeks
Title
Basal corneal epithelium density
Description
Basal corneal epithelium density analyzed by confocal microscopy expresed by cells /mm2
Time Frame
Change from baseline basal corneal epithelium density at 48 weeks
Title
Corneal Estroma reflectivity
Description
Corneal Estroma reflectivity analyzed by confocal microscopy expresed by 5-point scale of grade
Time Frame
Change from baseline in the grade of corneal estroma reflectivity at 48 weeks specify by 4 grade scale reported by Martone et al. .
Title
Corneal nerve density
Description
Corneal nerve density analyzed by confocal microscopy expresed by cells /mm2
Time Frame
Change from baseline corneal nerve density at 48 weeks
Title
Neuroma density
Description
Neuroma density analyzed by confocal microscopy expresed by neuromas/mm2
Time Frame
Change from baseline neuroma density at 48 weeks
Title
Dendrite density
Description
Dendrite density analyzed by confocal microscopy expresed by dendrites/mm2
Time Frame
Change from baseline dendrite density at 48 weeks
Title
Corneal nerve tortuosity
Description
Corneal nerve tortuosity analyzed by confocal microscopy expresed by 5-point scale of grade
Time Frame
Change from baseline in the grade of corneal nerve tortousity at 48 weeksusing a 5 point scale reported by Oliviera-Soto et al.
Title
Endothelial cell density
Description
endothelial cell density analyzed by confocal microscopy expresed by cells/mm2
Time Frame
Change from baseline endothelial cell count at 48 weeks
Title
Conjuctival epithelium density
Description
Conjuntival epithelium density analyzed by confocal microscopy expresed by cells/mm2
Time Frame
Change from baseline conjuctival epithelium density at 48 weeks
Title
Goblett cell density
Description
Goblett cell density nalyzed by confocal microscopy expresed by cells/mm2
Time Frame
Change from baseline goblett cell density at 48 weeks
Title
Inflamatory infiltrates
Description
Description of presence or absence of inflamtory cells on conjuntiva
Time Frame
Change from baseline in inflamatory infiltrates at 48 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Melina del Papa
Phone
01160480067
Email
mdelpapa@poen.net.ar
First Name & Middle Initial & Last Name or Official Title & Degree
Silvia Passerini, PharmD
Facility Information:
Facility Name
Clínica de Ojos Dr. Nano
City
Olivos
State/Province
Buenos Aires
ZIP/Postal Code
B1636CSS
Country
Argentina
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Fernando Cataldi, MD
Phone
+54 9 11 5830-2200
First Name & Middle Initial & Last Name & Degree
Fernando Cataldi, MD
First Name & Middle Initial & Last Name & Degree
Melanie Whity, MD
Facility Name
Consultorio Dr. Peyret
City
Ciudad Autonoma de Buenos Aire
State/Province
Ciudad Autónoma De Buenos Aires
ZIP/Postal Code
C1007ABK
Country
Argentina
Individual Site Status
Active, not recruiting
Facility Name
Gonella Oftalmólogos
City
Ciudad Autonoma de Buenos Aire
State/Province
Ciudad Autónoma De Buenos Aires
ZIP/Postal Code
C1122AAK
Country
Argentina
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ana Sanseau, MD
Phone
+54 9 11 5002-4211
First Name & Middle Initial & Last Name & Degree
Ana Sanseau, MD
Facility Name
Centro Diagnóstico Dr. Gentile
City
Ciudad Autonoma de Buenos Aire
State/Province
Ciudad Autónoma De Buenos Aires
ZIP/Postal Code
C1425AYA
Country
Argentina
Individual Site Status
Active, not recruiting
Facility Name
Centro oftalmológico Dr. Casiraghi & asociados
City
Ciudad Autónoma de Buenos Aire
State/Province
Ciudad Autónoma De Buenos Aires
ZIP/Postal Code
C1124
Country
Argentina
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Javier Casiraghi, MD
Phone
011 4822-0364
First Name & Middle Initial & Last Name & Degree
Javier Casiraghi, MD
Facility Name
Consultorios de Oftalmología
City
Ciudad autónoma de Buenos Aires
ZIP/Postal Code
C1425FAB
Country
Argentina
Individual Site Status
Active, not recruiting

12. IPD Sharing Statement

Learn more about this trial

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

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