Safety of Bosentan in Type II Diabetic Patients

Study Overview
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Brief Summary
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This study evaluates the safety of topical Bosentan in Type II Diabetes patients

Detailed Description
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The study is a Phase I, masked, placebo controlled clinical trial to assess safety of topical Bosentan in Type II Diabetes patients with no diabetes retinopathy

Official Title
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Masked, Placebo Controlled, Phase I Trial to Assess the Safety of Bosentan 5 mg/ml Ophthalmic Eyewash in Type II Diabetic Patients

Conditions
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Diabetes Mellitus

Intervention / Treatment
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* Drug: Bosentan
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Signed informed consent; Type II Diabetes Mellitus; 18 or more years old Exclusion Criteria: Pregnant or breastfeeding Women Known allergy or intolerance to investigational product or any of its excipients Severe corneal abnormalities Any relevant ocular / ophthalmic pathology that may put study results at risk in the opinion of Principal Investigator Any sign or symptom of Diabetes Retinopathy Any ocular surgery in the 6 previous months to study inclusion Uncontrolled diabetes in the previous 3 months to inclusion or HbA1c levels ≥ 9% at baseline. Oxford Scale or OSDI scores compatible with study failure at inclusion visit. (Oxford ≥ 5 or OSTDI ≥ 13) Previous hepatopathy history or signs of hepatopathy at baseline. Contact lens use Actual treatment with the commercially available presentation

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 99 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
Interventional Model Description: 1 Eye receives placebo, the other eye receives study drug. Eye elections is randomized
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment<br>The patient will receive investigational product in one eye and placebo in the other eye. The allocation of treatment / placebo is masked and randomized | Drug: Bosentan<br>* Eyedrop<br>|
| Placebo Comparator: Placebo<br>The patient will receive investigational product in one eye and placebo in the other eye. The allocation of treatment / placebo is masked and randomized | Drug: Placebo<br>* Ophthalmic eyedrop with the exact same excipient of the drug arm without the active compound<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Epitheliopathy | Presence of epitheliopathy in the cornea or conjunctiva | 1 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Presence of ocular discomfort | Presence of ocular discomfort assessed with Ocular Surface Disease Index (OSDI) questionnaire | 1 month | 
| Anterior segment inflammation | Presence of any sign of clinically significant inflammation at anterior segment | 1 month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Diabetes