Diabetes MellitusPhase 1BOSRETNCT04068272
Safety of Bosentan in Type II Diabetic Patients
A Phase 1 study testing Bosentan in people with Diabetes Mellitus, run by Retinset SL at 2 sites in Spain.
Trial summary
This study evaluates the safety of topical Bosentan in Type II Diabetes patients Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Diabetes Mellitus
- What is being tested?
- Bosentan
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 22 participants
- Where
- 2 sitesSpain
- Study dates
- 7 Sep 2019to 20 May 2022
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signed informed consent;
- Type II Diabetes Mellitus;
- 18 or more years old
Who cannot join
- 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
Show all 11Show fewer
- 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 locations and contacts
2 sites in 1 country.
Spain2 sites
Hospital Universitario de Bellvitge
L'Hospitalet de Llobregat, Barcelona, 08907
IOBA
Valladolid, 47011
About this study
Official title: Masked, Placebo Controlled, Phase I Trial to Assess the Safety of Bosentan 5 mg/ml Ophthalmic Eyewash in Type II Diabetic Patients
This study evaluates the safety of topical Bosentan in Type II Diabetes patients
Read the 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
- Conditions
- Diabetes Mellitus
- Being tested
- Bosentan, Placebo
- Keywords
- Diabetes
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BosentanDrug
Eyedrop
PlaceboDrug
Ophthalmic eyedrop with the exact same excipient of the drug arm without the active compound
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | The patient will receive investigational product in one eye and placebo in the other eye. The allocation of treatment / placebo is masked and randomized Receives: Drug: Bosentan |
| Placebo | Placebo comparator | The patient will receive investigational product in one eye and placebo in the other eye. The allocation of treatment / placebo is masked and randomized Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Epitheliopathy
Presence of epitheliopathy in the cornea or conjunctiva
Measured: 1 month
Secondary outcomes (2)
Presence of ocular discomfort
Presence of ocular discomfort assessed with Ocular Surface Disease Index (OSDI) questionnaire
Measured: 1 month
Anterior segment inflammation
Presence of any sign of clinically significant inflammation at anterior segment
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2019
- Study start7 Sep 2019
- Primary completion20 May 2022
- Study completion20 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes MellitusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 1 Eye receives placebo, the other eye receives study drug. Eye elections is randomized
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Retinset SL
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Instituto Universitario de Oftalmobiología Aplicada (Institute of Applied Ophthalmobiology) - IOBA
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04068272
- Sponsor's protocol ID
- IOBA-02-2016
- Acronym
- BOSRET
- Status last verified
- Feb 2023
- First submitted
- 22 Aug 2019
- Last updated
- 16 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Masked, Placebo Controlled, Phase I Trial to Assess the Safety of Bosentan 5 mg/ml Ophthalmic Eyewash in Type II Diabetic Patients
- ClinicalTrials.gov ID
- NCT04068272
- Acronym / sponsor ID
- BOSRET / IOBA-02-2016
- Conditions
- Diabetes Mellitus
- Keywords
- Diabetes
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Retinset SLIndustry (pharma, biotech, devices)
- Collaborators
- Instituto Universitario de Oftalmobiología Aplicada (Institute of Applied Ophthalmobiology) - IOBA
- Study start
- 7 Sep 2019 (actual)
- Primary completion
- 20 May 2022 (actual)
- Study completion
- 20 May 2022 (actual)
- First posted
- 28 Aug 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- 1 Eye receives placebo, the other eye receives study drug. Eye elections is randomized
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Drug: BosentanThe patient will receive investigational product in one eye and placebo in the other eye. The allocation of treatment / placebo is masked and randomized |
| Placebo | Placebo comparator | Drug: PlaceboThe patient will receive investigational product in one eye and placebo in the other eye. The allocation of treatment / placebo is masked and randomized |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Signed informed consent;
- Type II Diabetes Mellitus;
- 18 or more years old
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BosentanEyedrop | Drug | Treatment |
| PlaceboOphthalmic eyedrop with the exact same excipient of the drug arm without the active compound | Drug | Placebo |
Primary outcome
Epitheliopathy
Time frame: 1 month
Presence of epitheliopathy in the cornea or conjunctiva
2 secondary outcomes
Presence of ocular discomfort
Time frame: 1 month
Anterior segment inflammation
Time frame: 1 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Feb 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Bosentan in people with Diabetes Mellitus, run by Retinset SL at 2 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Epitheliopathy (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Feb 2023.