Status:
COMPLETED
Safety of Bosentan in Type II Diabetic Patients
Lead Sponsor:
Retinset SL
Collaborating Sponsors:
Instituto Universitario de Oftalmobiología Aplicada (Institute of Applied Ophthalmobiology) - IOBA
Conditions:
Diabetes Mellitus
Eligibility:
All Genders
18-99 years
Phase:
PHASE1
Brief Summary
This study evaluates the safety of topical Bosentan in Type II Diabetes patients
Detailed Description
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
Eligibility Criteria
Inclusion
- Signed informed consent;
- Type II Diabetes Mellitus;
- 18 or more years old
Exclusion
- 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
Key Trial Info
Start Date :
September 7 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 20 2022
Estimated Enrollment :
22 Patients enrolled
Trial Details
Trial ID
NCT04068272
Start Date
September 7 2019
End Date
May 20 2022
Last Update
February 16 2023
Active Locations (2)
Enter a location and click search to find clinical trials sorted by distance.
1
Hospital Universitario de Bellvitge
L'Hospitalet de Llobregat, Barcelona, Spain, 08907
2
IOBA
Valladolid, Spain, 47011