Safety of Bosentan in Type II Diabetic Patients

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04068272

Acronym

BOSRET

Enrollment

Registered

2019-08-28

Start date

2019-09-07

Completion date

2022-05-20

Last updated

2023-02-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes Mellitus

Keywords

Diabetes

Brief summary

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

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

Interventions

DRUGBosentan

Eyedrop

DRUGPlacebo

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Masking description

Placebo and Study Drug have the same physical characteristics, labeling and packaging

Intervention model description

1 Eye receives placebo, the other eye receives study drug. Eye elections is randomized

Eligibility

Sex/Gender

ALL

Age

18 Years to 99 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Epitheliopathy	1 month	Presence of epitheliopathy in the cornea or conjunctiva

Secondary

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

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026