Study evaluating a new drug to treat participants with Demodex blepharitis (inflammation of the eyelids)
| ISRCTN | ISRCTN12449602 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN12449602 |
| Secondary identifying numbers | TRS-004 |
- Submission date
- 18/02/2021
- Registration date
- 11/03/2021
- Last edited
- 11/03/2021
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Eye Diseases
Plain English summary of protocol
Background and study aims
The purpose of this study is to evaluate the safety and efficacy of an eyedrop treatment for a condition known as blepharitis, which causes inflammation of the eye and dry eyes, due to infestation with the Demodex mite, which lives in the eyelashes.
Who can participate?
Adult participants with blepharitis due to Demodex infestation.
What does the study involve?
Participants will be allocated to one of two groups, with an equal chance of being in either group (like tossing a coin). Participants and researchers will not have a choice in the treatment given and participants will not know which treatment they have received during the study period. The first group of participants will receive the study drug TP-03 eyedrops and the second of participants will receive eyedrops that appear identical but do not contain active ingredients. Participants will be asked to apply the treatment they have received to each eye, twice a day, for 28 days.
What are the possible benefits and risks of participating?
Participants who receive the study drug may experience an improvement in their symptoms of eye inflammation. Participants who do not receive the study drug may not receive any direct benefit.
Potential risks for participation in this study include eye irritation (redness and/or inflammation) due to either the study drug or the inactive treatment.
Where is the study run from?
Asociacion para Evitar la Ceguera (APEC) Departamento de lnvestigacion (Mexico)
When is the study starting and how long is it expected to run for?
From March 2019 to August 2019
Who is funding the study?
Tarsus Pharmaceuticals (USA)
Who is the main contact?
Roberto Gonzalez Salinas, dr.gonzalezsalinas@gmail.com
Contact information
Scientific
Vicente Garcia Torres 46
Colonia Barrio San Lucas
Coyoacan
Ciudad de Mexico
04030
Mexico
 ORCID ID |
0000-0001-6654-5191 |
|---|---|
| Phone | +52 442 219 9424 |
| dr.gonzalezsalinas@gmail.com |
Study information
| Study design | Prospective double-masked single-centre randomized parallel vehicle-controlled study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised parallel trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | No participant information sheet available |
| Scientific title | Randomized, vehicle controlled, double-blind, parallel trial to evaluate the safety and efficacy of TP- 03 for the treatment of blepharitis due to Demodex infestation (Jupiter) |
| Study acronym | Jupiter |
| Study objectives | Treatment with TP-03 will result in a significant decrease from baseline in Demodex density (mites/lash) at day 28 compared to the vehicle control. Any ocular irritation experienced will be mild and similar to the vehicle control in frequency and severity. |
| Ethics approval(s) | Approved 05/03/2019, Ethics and Research Committee, Asociacion para Evitar la Ceguera en Mexico I.A P. (Association to Prevent Blindness in Mexico I.A P., Vicente Garcia Torres 46, Colonia Barrio San Lucas Coyoacan, Ciudad de Mexico 04030; +52 10 84 14 00; no email address provided), ref: none provided |
| Health condition(s) or problem(s) studied | Eyelid inflammation due to a parasitic (Demodex) infestation |
| Intervention | This study is intended to evaluate the safety and efficacy of TP-03, ophthalmic solution, 0.25% compared to vehicle control for the treatment of blepharitis due to Demodex infestation. Participants will be randomized 1:1 in the active and control arms and will use the study drug twice a day for 28 days. A computer-generated block randomization schedule will be used to label the study drug and bottles will be assigned to participants on a consecutive basis. Participation in the study will last for up to 90 days post-initiation of treatment. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Phase II |
| Drug / device / biological / vaccine name(s) | TP-03 (topical ophthalmic preparation of lotilaner) |
| Primary outcome measure | Change in Demodex density calculated as the number of mites per lash measured using lash epilation and mite counting via microscope at baseline and 28 days |
| Secondary outcome measures | Change in collarette grading measured using slit lamp biomicroscopy at baseline, 14, and 28 days |
| Overall study start date | 01/01/2019 |
| Completion date | 19/08/2019 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 60 total. Two clusters, active and vehicle control, with 30 in each. |
| Total final enrolment | 60 |
| Key inclusion criteria | 1. Willing to sign the informed consent and deemed capable of complying with the requirements of the study protocol 2. Participants must meet all of the following criteria in at least one eye: 2.1. More than 10 collarettes present on the upper lid 2.2. Mild to severe lid margin erythema 2.3. Average Demodex density of 1.5 or more mites per lash 3. Aged ≥18 years |
| Key exclusion criteria | 1. Systemic or topical antibacterial, antiparasitic or anti-inflammatory steroid treatment within the last 14 days 2. Topical tea tree oil or hypochlorous acid treatment of the ophthalmic area within the last 14 days 3. Use of lid hygiene products (eyelid scrubs) in the last 14 days or unwilling to forego the use of lid hygiene products during the study |
| Date of first enrolment | 07/03/2019 |
| Date of final enrolment | 25/04/2019 |
Locations
Countries of recruitment
- Mexico
Study participating centre
Colonia Barrio San Lucas
Coyoacan
Ciudad de Mexico
04030
Mexico
Sponsor information
Hospital/treatment centre
Asociacion Para Evitar la Ceguera en México Hospital
Vicente Garcia Torres 46
Colonia Barrio San Lucas
Coyoacan Delgation
Ciudad de Mexico
04030
Mexico
| Phone | +52 442 219 9424 |
|---|---|
| dr.gonzalezsalinas@gmail.com | |
| Website | http://apec.org.mx/ |
Funders
Funder type
Industry
No information available
Results and Publications
| Intention to publish date | 31/12/2021 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not expected to be made available |
| Publication and dissemination plan | Planned publication in a peer-reviewed journal. |
| IPD sharing plan | There is no plan to share participant-level data as the investigational product data has not yet been submitted to a regulatory authority. |
Editorial Notes
02/03/2021: Trial’s existence confirmed by Asociacion Para Evitar la Ceguera en México Hospital.
