Safety of Bosentan in Type II Diabetic Patients

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

22 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-09-07

Study Completion Date

2022-05-20

Brief Summary

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

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Detailed Description

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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

Conditions

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Diabetes Mellitus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

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

Study Groups

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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

Group Type EXPERIMENTAL

Bosentan

Intervention Type DRUG

Eyedrop

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

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

Interventions

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Bosentan

Eyedrop

Intervention Type DRUG

Placebo

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

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No