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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Glaucoma, Open-Angle, Ocular Hypertension

Intervention / Treatment
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* Drug: Dorzolamide / Timolol Ophthalmic Solution
* Drug: dorzolamide/timolol


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Dorzolamide+Timolol PF<br>Glaucotensil TD LC, Laboratorios Poen | Drug: Dorzolamide / Timolol Ophthalmic Solution<br>* Dorzolamide-timolol fixed combination in a preservative-free multidose device<br>* Other names: Glaucotensil TD LC;|
| Experimental: Dorzolamide + Timolol BAK<br>Glaucotensil TD, Laboratorios Poen | Drug: dorzolamide/timolol<br>* Dorzolamide-timolol BAK-preserved fixed combination<br>* Other names: Glaucotensil TD;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ocular Surface Disease Symptoms | OSDI questtionarie | Change from baseline in OSDI score at 24 weeks | 

Secondary Outcome Measures

| Outcome Measure | 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) | 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 |