Safety of Bosentan in Type II Diabetic Patients

• Status: Recruiting
• Trial end date: 2022-12-31
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Retinset SL
• Collaborator: Instituto Universitario de Oftalmobiología Aplicada (Institute of Applied Ophthalmobiology) - IOBA
• Treatments: Bosentan

Criteria

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