Safety of Bosentan in Type II Diabetic Patients (BOSRET)

February 15, 2023 updated by: Retinset SL

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Actual)

22

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Valladolid, Spain, 47011
        • IOBA
    • Barcelona
      • L'Hospitalet de Llobregat, Barcelona, Spain, 08907
        • Hospital Universitario de Bellvitge

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 99 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Treatment
The patient will receive investigational product in one eye and placebo in the other eye. The allocation of treatment / placebo is masked and randomized
Drug: Bosentan
Eyedrop
Placebo Comparator: Placebo
The patient will receive investigational product in one eye and placebo in the other eye. The allocation of treatment / placebo is masked and randomized
Drug: Placebo
Ophthalmic eyedrop with the exact same excipient of the drug arm without the active compound

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Epitheliopathy
Time Frame: 1 month
Presence of epitheliopathy in the cornea or conjunctiva
1 month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Presence of ocular discomfort
Time Frame: 1 month
Presence of ocular discomfort assessed with Ocular Surface Disease Index (OSDI) questionnaire
1 month
Anterior segment inflammation
Time Frame: 1 month
Presence of any sign of clinically significant inflammation at anterior segment
1 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Retinset SL

Collaborators

Instituto Universitario de Oftalmobiología Aplicada (Institute of Applied Ophthalmobiology) - IOBA

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 7, 2019

Primary Completion (Actual)

May 20, 2022

Study Completion (Actual)

May 20, 2022

Study Registration Dates

First Submitted

August 22, 2019

First Submitted That Met QC Criteria

August 22, 2019

First Posted (Actual)

August 28, 2019

Study Record Updates

Last Update Posted (Estimate)

February 16, 2023

Last Update Submitted That Met QC Criteria

February 15, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IOBA-02-2016

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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