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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dorzolamide+Timolol PF | Experimental | Glaucotensil TD LC, Laboratorios Poen |
|
| Dorzolamide + Timolol BAK | Experimental | Glaucotensil TD, Laboratorios Poen |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dorzolamide / Timolol Ophthalmic Solution | Drug | Dorzolamide-timolol fixed combination in a preservative-free multidose device |
|
| Measure | Description | Time Frame |
|---|---|---|
| Ocular Surface Disease Symptoms | OSDI questtionarie | Change from baseline in OSDI score at 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Intraocular preassure | Intraocular preassure (PIO) by GAT | Change from baseline in PIO (mmHg) at 24 weeks |
| Break-up Time | Break-up Time (BUT) |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Basal corneal epithelium density |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clínica de Ojos Dr. Nano | Olivos | Buenos Aires | B1636CSS | Argentina | ||
| Consultorio Dr. Peyret |
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| dorzolamide/timolol | Drug | Dorzolamide-timolol BAK-preserved fixed combination |
|
|
| Change from baseline BUT (seconds) at 24 weeks |
| SCHIRMER-ITEST | Schirmer test without anesthesia | Change from baseline Shirmer test (mm) at 24 weeks |
| Conjunctival Hyperemia | Conjunctival Hyperemia | Change from baseline in porcentaje of patients with conjunctival hyperemia at 24 weeks |
| Satisfaction questionnaire | Satisfaction questionnaire | Change from baseline of patient satisfaction at 24 weeks using a 5-point likert scale |
| Best corrected visual acuity | snellen scale 20/20 | Change from baseline visual acuity at 24 weeks |
| Treatment preference | Treatment preference | Treatment preference with respect previous treatment at Week 24 |
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 | 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 | Corneal nerve density analyzed by confocal microscopy expresed by cells /mm2 | Change from baseline corneal nerve density at 48 weeks |
| Neuroma density | Neuroma density analyzed by confocal microscopy expresed by neuromas/mm2 | Change from baseline neuroma density at 48 weeks |
| Dendrite density | Dendrite density analyzed by confocal microscopy expresed by dendrites/mm2 | Change from baseline dendrite density at 48 weeks |
| 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. |
| Endothelial cell density | endothelial cell density analyzed by confocal microscopy expresed by cells/mm2 | Change from baseline endothelial cell count at 48 weeks |
| Conjuctival epithelium density | Conjuntival epithelium density analyzed by confocal microscopy expresed by cells/mm2 | Change from baseline conjuctival epithelium density at 48 weeks |
| Goblett cell density | Goblett cell density nalyzed by confocal microscopy expresed by cells/mm2 | Change from baseline goblett cell density at 48 weeks |
| Inflamatory infiltrates | Description of presence or absence of inflamtory cells on conjuntiva | Change from baseline in inflamatory infiltrates at 48 weeks |
| Ciudad Autonoma de Buenos Aire |
| Buenos Aires F.D. |
| C1007ABK |
| Argentina |
| Gonella Oftalmólogos | Ciudad Autonoma de Buenos Aire | Buenos Aires F.D. | C1122AAK | Argentina |
| Centro Diagnóstico Dr. Gentile | Ciudad Autonoma de Buenos Aire | Buenos Aires F.D. | C1425AYA | Argentina |
| Centro oftalmológico Dr. Casiraghi & asociados | Ciudad Autónoma de Buenos Aire | Buenos Aires F.D. | C1124 | Argentina |
| Consultorios de Oftalmología | Buenos Aires | C1425FAB | Argentina |
| ID | Term |
|---|---|
| D005902 | Glaucoma, Open-Angle |
| D009798 | Ocular Hypertension |
| ID | Term |
|---|---|
| D005901 | Glaucoma |
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| C062765 | dorzolamide |
| C479140 | dorzolamide-timolol combination |
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