Dorzolamide / Timolol Ophthalmic Solution
DrugDorzolamide-timolol fixed combination in a preservative-free multidose device
Other names: Glaucotensil TD LC
NCT Number: NCT05857267
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.
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Notify Me18 year and older
All sexes
Interventional
Phase 4
Clínica de Ojos Dr. Nano, Olivos, Buenos Aires, Argentina
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Dorzolamide-timolol fixed combination in a preservative-free multidose device
Other names: Glaucotensil TD LC
Dorzolamide-timolol BAK-preserved fixed combination
Other names: Glaucotensil TD
Time frame: Change from baseline in OSDI score at 24 weeks
OSDI questtionarie
Time frame: Change from baseline in PIO (mmHg) at 24 weeks
Intraocular preassure (PIO) by GAT
Time frame: Change from baseline BUT (seconds) at 24 weeks
Break-up Time (BUT)
Time frame: Change from baseline Shirmer test (mm) at 24 weeks
Schirmer test without anesthesia
Time frame: Change from baseline in porcentaje of patients with conjunctival hyperemia at 24 weeks
Conjunctival Hyperemia
Time frame: Change from baseline of patient satisfaction at 24 weeks using a 5-point likert scale
Satisfaction questionnaire
Time frame: Change from baseline visual acuity at 24 weeks
snellen scale 20/20
Time frame: Treatment preference with respect previous treatment at Week 24
Treatment preference
Time frame: Change from baseline superficial corneal epithelium density at 48 weeks
Superficial corneal epithelium density analyzed by confocal microscopy expresed by cells /mm2
Time frame: Change from baseline basal corneal epithelium density at 48 weeks
Basal corneal epithelium density analyzed by confocal microscopy expresed by cells /mm2
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
Time frame: Change from baseline corneal nerve density at 48 weeks
Corneal nerve density analyzed by confocal microscopy expresed by cells /mm2
Time frame: Change from baseline neuroma density at 48 weeks
Neuroma density analyzed by confocal microscopy expresed by neuromas/mm2
Time frame: Change from baseline dendrite density at 48 weeks
Dendrite density analyzed by confocal microscopy expresed by dendrites/mm2
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
Time frame: Change from baseline endothelial cell count at 48 weeks
endothelial cell density analyzed by confocal microscopy expresed by cells/mm2
Time frame: Change from baseline conjuctival epithelium density at 48 weeks
Conjuntival epithelium density analyzed by confocal microscopy expresed by cells/mm2
Time frame: Change from baseline goblett cell density at 48 weeks
Goblett cell density nalyzed by confocal microscopy expresed by cells/mm2
Time frame: Change from baseline in inflamatory infiltrates at 48 weeks
Description of presence or absence of inflamtory cells on conjuntiva
Laboratorios Poen
Industry
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
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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