Safety of Bosentan in Type II Diabetic Patients

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

This study evaluates the safety of topical Bosentan in Type II Diabetes patients

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

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