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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04068272
Other study ID # IOBA-02-2016
Secondary ID
Status Completed
Phase Phase 1
First received
Last updated
Start date September 7, 2019
Est. completion date May 20, 2022

Study information

Verified date February 2023
Source Retinset SL
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


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


Recruitment information / eligibility

Status Completed
Enrollment 22
Est. completion date May 20, 2022
Est. primary completion date May 20, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years to 99 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Bosentan
Eyedrop
Placebo
Ophthalmic eyedrop with the exact same excipient of the drug arm without the active compound

Locations

Country Name City State
Spain Hospital Universitario de Bellvitge L'Hospitalet de Llobregat Barcelona
Spain IOBA Valladolid

Sponsors (2)

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

Country where clinical trial is conducted

Spain, 

Outcome

Type Measure Description Time frame Safety issue
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
Secondary Anterior segment inflammation Presence of any sign of clinically significant inflammation at anterior segment 1 month
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