Glaucoma, Open-Angle, Ocular Hypertension
Conditions
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.
Interventions
DRUGDorzolamide / Timolol Ophthalmic Solution
Dorzolamide-timolol fixed combination in a preservative-free multidose device
Dorzolamide-timolol BAK-preserved fixed combination
Sponsors
Laboratorios Poen
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Ocular Surface Disease Symptoms | Change from baseline in OSDI score at 24 weeks | OSDI questtionarie |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Break-up Time | Change from baseline BUT (seconds) at 24 weeks | Break-up Time (BUT) |
| SCHIRMER-ITEST | Change from baseline Shirmer test (mm) at 24 weeks | Schirmer test without anesthesia |
| Conjunctival Hyperemia | Change from baseline in porcentaje of patients with conjunctival hyperemia at 24 weeks | Conjunctival Hyperemia |
| Intraocular preassure | Change from baseline in PIO (mmHg) at 24 weeks | Intraocular preassure (PIO) by GAT |
| Best corrected visual acuity | Change from baseline visual acuity at 24 weeks | snellen scale 20/20 |
| Treatment preference | Treatment preference with respect previous treatment at Week 24 | Treatment preference |
| Satisfaction questionnaire | Change from baseline of patient satisfaction at 24 weeks using a 5-point likert scale | Satisfaction questionnaire |
Other
| Measure | Time frame | Description |
|---|---|---|
| Conjuctival epithelium density | Change from baseline conjuctival epithelium density at 48 weeks | Conjuntival epithelium density analyzed by confocal microscopy expresed by cells/mm2 |
| Superficial corneal epithelium density | Change from baseline superficial corneal epithelium density at 48 weeks | Superficial corneal epithelium density analyzed by confocal microscopy expresed by cells /mm2 |
| Inflamatory infiltrates | Change from baseline in inflamatory infiltrates at 48 weeks | Description of presence or absence of inflamtory cells on conjuntiva |
| Goblett cell density | Change from baseline goblett cell density at 48 weeks | Goblett cell density nalyzed by confocal microscopy expresed by cells/mm2 |
| Basal corneal epithelium density | Change from baseline basal corneal epithelium density at 48 weeks | Basal corneal epithelium density analyzed by confocal microscopy expresed by cells /mm2 |
| Corneal Estroma reflectivity | 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 |
| Corneal nerve density | Change from baseline corneal nerve density at 48 weeks | Corneal nerve density analyzed by confocal microscopy expresed by cells /mm2 |
| Neuroma density | Change from baseline neuroma density at 48 weeks | Neuroma density analyzed by confocal microscopy expresed by neuromas/mm2 |
| Dendrite density | Change from baseline dendrite density at 48 weeks | Dendrite density analyzed by confocal microscopy expresed by dendrites/mm2 |
| Corneal nerve tortuosity | 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 |
| Endothelial cell density | Change from baseline endothelial cell count at 48 weeks | endothelial cell density analyzed by confocal microscopy expresed by cells/mm2 |
Countries
Argentina
Outcome results
None listed