Safety of Bosentan in Type II Diabetic Patients (BOSRET)

Retinset

Status and phase: Completed; Phase 1

Conditions: Diabetes Mellitus

Treatments: Drug: Placebo; Drug: Bosentan

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04068272

IOBA-02-2016

Details and patient eligibility

About

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

Full 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

Enrollment: 22 patients

Sex: All

Ages: 18 to 99 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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22 participants in 2 patient groups, including a placebo group

Treatment

Experimental group

Description:

The patient will receive investigational product in one eye and placebo in the other eye. The allocation of treatment / placebo is masked and randomized

Treatment:

Drug: Bosentan

Placebo

Placebo Comparator group

Description:

The patient will receive investigational product in one eye and placebo in the other eye. The allocation of treatment / placebo is masked and randomized

Treatment:

Drug: Placebo