BOSRET: Safety of Bosentan in Type II Diabetic Patients

Sponsor

Retinset SL (Industry)

Overall Status

Recruiting

CT.gov ID

NCT04068272

Collaborator

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

Enrollment

Locations

Arms

39.8

Anticipated Duration (Months)

Patients Per Site

0.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Diabetes Mellitus	Drug: Bosentan Drug: Placebo	Phase 1

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 Design

Study Type:

Interventional

Anticipated Enrollment :

22 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

1 Eye receives placebo, the other eye receives study drug. Eye elections is randomized1 Eye receives placebo, the other eye receives study drug. Eye elections is randomized

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Masking Description:

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

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Sep 7, 2019

Anticipated Primary Completion Date :

Dec 31, 2022

Anticipated Study Completion Date :

Dec 31, 2022

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Epitheliopathy [1 month]
Presence of epitheliopathy in the cornea or conjunctiva

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 99 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hospital Universitario de Bellvitge	L'Hospitalet de Llobregat	Barcelona	Spain	08907
2	IOBA	Valladolid		Spain	47011

Sponsors and Collaborators

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

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Retinset SL

ClinicalTrials.gov Identifier:

NCT04068272

Other Study ID Numbers:

IOBA-02-2016

First Posted:

Aug 28, 2019

Last Update Posted:

Apr 21, 2021

Last Verified:

Apr 1, 2021

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Retinset SL

Diabetes

Additional relevant MeSH terms:

Bosentan

Study Results

No Results Posted as of Apr 21, 2021