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Completed

NCT Number: NCT04068272

Safety of Bosentan in Type II Diabetic Patients

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

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Key information

Conditions

Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Hospital Universitario de Bellvitge, L'Hospitalet de Llobregat, Barcelona, Spain

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About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Bosentan

Drug

Eyedrop

Placebo

Drug

Ophthalmic eyedrop with the exact same excipient of the drug arm without the active compound

Primary outcomes

  1. Epitheliopathy

    Time frame: 1 month

    Presence of epitheliopathy in the cornea or conjunctiva

Secondary outcomes

  1. Presence of ocular discomfort

    Time frame: 1 month

    Presence of ocular discomfort assessed with Ocular Surface Disease Index (OSDI) questionnaire

  2. Anterior segment inflammation

    Time frame: 1 month

    Presence of any sign of clinically significant inflammation at anterior segment

Sponsors and collaborators

Lead sponsor

Retinset SL

Industry

Collaborators

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

Registry information

Official study title

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

Acronym: BOSRET

Important dates

Study start
2019
Primary completion
2022
Study completion
2022
First posted
Aug 28, 2019
Registry last updated
Feb 16, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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