| Trial ID: | L2957 |
| Source ID: | NCT04068272
|
| Associated Drug: |
Bosentan
|
| Title: |
Safety of Bosentan in Type II Diabetic Patients
|
| Acronym: |
BOSRET
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Diabetes Mellitus
|
| Interventions: |
DRUG: Bosentan|DRUG: Placebo
|
| Outcome Measures: |
Primary: Epitheliopathy, Presence of epitheliopathy in the cornea or conjunctiva, 1 month | Secondary: 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
|
| Sponsor/Collaborators: |
Sponsor: Retinset SL | Collaborators: Instituto Universitario de Oftalmobiología Aplicada (Institute of Applied Ophthalmobiology) - IOBA
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE1
|
| Enrollment: |
22
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
|
| Start Date: |
2019-09-07
|
| Completion Date: |
2022-05-20
|
| Results First Posted: |
|
| Last Update Posted: |
2023-02-16
|
| Locations: |
Hospital Universitario de Bellvitge, L'Hospitalet de Llobregat, Barcelona, 08907, Spain|IOBA, Valladolid, 47011, Spain
|
| URL: |
https://clinicaltrials.gov/show/NCT04068272
|
