Safety of Bosentan in Type II Diabetic Patients
BOSRET
Masked, Placebo Controlled, Phase I Trial to Assess the Safety of Bosentan 5 mg/ml Ophthalmic Eyewash in Type II Diabetic Patients
1 other identifier
interventional
22
1 country
2
Brief Summary
This study evaluates the safety of topical Bosentan in Type II Diabetes patients
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1 diabetes-mellitus
Started Sep 2019
Longer than P75 for phase_1 diabetes-mellitus
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 22, 2019
CompletedFirst Posted
Study publicly available on registry
August 28, 2019
CompletedStudy Start
First participant enrolled
September 7, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 20, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
May 20, 2022
CompletedFebruary 16, 2023
February 1, 2023
2.7 years
August 22, 2019
February 15, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Epitheliopathy
Presence of epitheliopathy in the cornea or conjunctiva
1 month
Secondary Outcomes (2)
Presence of ocular discomfort
1 month
Anterior segment inflammation
1 month
Study Arms (2)
Treatment
EXPERIMENTALThe patient will receive investigational product in one eye and placebo in the other eye. The allocation of treatment / placebo is masked and randomized
Placebo
PLACEBO COMPARATORThe patient will receive investigational product in one eye and placebo in the other eye. The allocation of treatment / placebo is masked and randomized
Interventions
Eligibility Criteria
You may qualify if:
- Signed informed consent;
- Type II Diabetes Mellitus;
- or more years old
You may not qualify if:
- 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
- Previous hepatopathy history or signs of hepatopathy at baseline.
- Contact lens use
- Actual treatment with the commercially available presentation
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Hospital Universitario de Bellvitge
L'Hospitalet de Llobregat, Barcelona, 08907, Spain
IOBA
Valladolid, 47011, Spain
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Masking Details
- Placebo and Study Drug have the same physical characteristics, labeling and packaging
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 22, 2019
First Posted
August 28, 2019
Study Start
September 7, 2019
Primary Completion
May 20, 2022
Study Completion
May 20, 2022
Last Updated
February 16, 2023
Record last verified: 2023-02