Safety of Bosentan in Type II Diabetic Patients

Diabetes Mellitus Clinical Trial

— BOSRET  

Official title:

Masked, Placebo Controlled, Phase I Trial to Assess the Safety of Bosentan 5 mg/ml Ophthalmic Eyewash in Type II Diabetic Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04068272
• Other study ID #: IOBA-02-2016
• Status: Completed
• Phase: Phase 1
• 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
• 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

Related Conditions & MeSH terms

• Diabetes Mellitus

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