- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05857267
Dorzolamide+Timolol Multidose Preservative-free vs Dorzolamida+Timolol BAK Preserved Efficacy and Safety
April 4, 2024 updated by: Laboratorios Poen
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
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 Overview
Status
Recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
84
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Melina del Papa
- Phone Number: 01160480067
- Email: mdelpapa@poen.net.ar
Study Contact Backup
- Name: Silvia Passerini, PharmD
Study Locations
-
-
-
Ciudad autónoma de Buenos Aires, Argentina, C1425FAB
- Active, not recruiting
- Consultorios de Oftalmología
-
-
Buenos Aires
-
Olivos, Buenos Aires, Argentina, B1636CSS
- Recruiting
- Clínica de Ojos Dr. Nano
-
Contact:
- Fernando Cataldi, MD
- Phone Number: +54 9 11 5830-2200
-
Principal Investigator:
- Fernando Cataldi, MD
-
Sub-Investigator:
- Melanie Whity, MD
-
-
Ciudad Autónoma De Buenos Aires
-
Ciudad Autonoma de Buenos Aire, Ciudad Autónoma De Buenos Aires, Argentina, C1007ABK
- Active, not recruiting
- Consultorio Dr. Peyret
-
Ciudad Autonoma de Buenos Aire, Ciudad Autónoma De Buenos Aires, Argentina, C1122AAK
- Recruiting
- Gonella Oftalmólogos
-
Contact:
- Ana Sanseau, MD
- Phone Number: +54 9 11 5002-4211
-
Principal Investigator:
- Ana Sanseau, MD
-
Ciudad Autonoma de Buenos Aire, Ciudad Autónoma De Buenos Aires, Argentina, C1425AYA
- Active, not recruiting
- Centro Diagnóstico Dr. Gentile
-
Ciudad Autónoma de Buenos Aire, Ciudad Autónoma De Buenos Aires, Argentina, C1124
- Not yet recruiting
- Centro oftalmológico Dr. Casiraghi & asociados
-
Contact:
- Javier Casiraghi, MD
- Phone Number: 011 4822-0364
-
Principal Investigator:
- Javier Casiraghi, MD
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Dorzolamide+Timolol PF
Glaucotensil TD LC, Laboratorios Poen
|
Dorzolamide-timolol fixed combination in a preservative-free multidose device
Other Names:
|
Experimental: Dorzolamide + Timolol BAK
Glaucotensil TD, Laboratorios Poen
|
Dorzolamide-timolol BAK-preserved fixed combination
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Ocular Surface Disease Symptoms
Time Frame: Change from baseline in OSDI score at 24 weeks
|
OSDI questtionarie
|
Change from baseline in OSDI score at 24 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Intraocular preassure
Time Frame: Change from baseline in PIO (mmHg) at 24 weeks
|
Intraocular preassure (PIO) by GAT
|
Change from baseline in PIO (mmHg) at 24 weeks
|
Break-up Time
Time Frame: Change from baseline BUT (seconds) at 24 weeks
|
Break-up Time (BUT)
|
Change from baseline BUT (seconds) at 24 weeks
|
SCHIRMER-ITEST
Time Frame: Change from baseline Shirmer test (mm) at 24 weeks
|
Schirmer test without anesthesia
|
Change from baseline Shirmer test (mm) at 24 weeks
|
Conjunctival Hyperemia
Time Frame: Change from baseline in porcentaje of patients with conjunctival hyperemia at 24 weeks
|
Conjunctival Hyperemia
|
Change from baseline in porcentaje of patients with conjunctival hyperemia at 24 weeks
|
Satisfaction questionnaire
Time Frame: Change from baseline of patient satisfaction at 24 weeks using a 5-point likert scale
|
Satisfaction questionnaire
|
Change from baseline of patient satisfaction at 24 weeks using a 5-point likert scale
|
Best corrected visual acuity
Time Frame: Change from baseline visual acuity at 24 weeks
|
snellen scale 20/20
|
Change from baseline visual acuity at 24 weeks
|
Treatment preference
Time Frame: Treatment preference with respect previous treatment at Week 24
|
Treatment preference
|
Treatment preference with respect previous treatment at Week 24
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Superficial corneal epithelium density
Time Frame: Change from baseline superficial corneal epithelium density at 48 weeks
|
Superficial corneal epithelium density analyzed by confocal microscopy expresed by cells /mm2
|
Change from baseline superficial corneal epithelium density at 48 weeks
|
Basal corneal epithelium density
Time Frame: Change from baseline basal corneal epithelium density at 48 weeks
|
Basal corneal epithelium density analyzed by confocal microscopy expresed by cells /mm2
|
Change from baseline basal corneal epithelium density at 48 weeks
|
Corneal Estroma reflectivity
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. .
|
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. .
|
Corneal nerve density
Time Frame: Change from baseline corneal nerve density at 48 weeks
|
Corneal nerve density analyzed by confocal microscopy expresed by cells /mm2
|
Change from baseline corneal nerve density at 48 weeks
|
Neuroma density
Time Frame: Change from baseline neuroma density at 48 weeks
|
Neuroma density analyzed by confocal microscopy expresed by neuromas/mm2
|
Change from baseline neuroma density at 48 weeks
|
Dendrite density
Time Frame: Change from baseline dendrite density at 48 weeks
|
Dendrite density analyzed by confocal microscopy expresed by dendrites/mm2
|
Change from baseline dendrite density at 48 weeks
|
Corneal nerve tortuosity
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.
|
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.
|
Endothelial cell density
Time Frame: Change from baseline endothelial cell count at 48 weeks
|
endothelial cell density analyzed by confocal microscopy expresed by cells/mm2
|
Change from baseline endothelial cell count at 48 weeks
|
Conjuctival epithelium density
Time Frame: Change from baseline conjuctival epithelium density at 48 weeks
|
Conjuntival epithelium density analyzed by confocal microscopy expresed by cells/mm2
|
Change from baseline conjuctival epithelium density at 48 weeks
|
Goblett cell density
Time Frame: Change from baseline goblett cell density at 48 weeks
|
Goblett cell density nalyzed by confocal microscopy expresed by cells/mm2
|
Change from baseline goblett cell density at 48 weeks
|
Inflamatory infiltrates
Time Frame: Change from baseline in inflamatory infiltrates at 48 weeks
|
Description of presence or absence of inflamtory cells on conjuntiva
|
Change from baseline in inflamatory infiltrates at 48 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 7, 2023
Primary Completion (Estimated)
October 4, 2024
Study Completion (Estimated)
November 15, 2024
Study Registration Dates
First Submitted
March 30, 2023
First Submitted That Met QC Criteria
May 10, 2023
First Posted (Actual)
May 12, 2023
Study Record Updates
Last Update Posted (Actual)
April 5, 2024
Last Update Submitted That Met QC Criteria
April 4, 2024
Last Verified
April 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Eye Diseases
- Glaucoma
- Glaucoma, Open-Angle
- Ocular Hypertension
- Physiological Effects of Drugs
- Adrenergic beta-Antagonists
- Adrenergic Antagonists
- Adrenergic Agents
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Anti-Arrhythmia Agents
- Antihypertensive Agents
- Enzyme Inhibitors
- Carbonic Anhydrase Inhibitors
- Pharmaceutical Solutions
- Timolol
- Dorzolamide
- Ophthalmic Solutions
Other Study ID Numbers
- ANTIGLAULC01
Drug and device information, study documents
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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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