Study evaluating a new drug for the treatment of blepharitis (eyelid inflammation) due to Demodex (mite) infestation
| ISRCTN | ISRCTN24398865 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN24398865 |
| ClinicalTrials.gov number | Nil known |
| Secondary identifying numbers | TRS-005 |
- Submission date
- 05/05/2021
- Registration date
- 17/05/2021
- Last edited
- 23/08/2021
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Infections and Infestations
Plain English summary of protocol
Background and study aims
Chronic blepharitis is inflammation that primarily involves the eyelid and is a common cause of eye irritation. The presence of the Demodex folliculorum mite in the eyelid structures of man has been recognized and implicated as a cause of chronic blepharitis. This interventional study was designed to evaluate the safety and efficacy of TP-03 for the treatment of blepharitis due to Demodex infestation.
Who can participate?
Males and females 18 years of age or older were randomized to the vehicle control in a previous study.
What does the study involve?
Participants will instill one drop of the active treatment solution (TP-03, 0.25%) in each eye, twice a day, morning and evening for 42 days.
What are the possible benefits and risks of participating?
Benefits include a possible reduction in the participant's cylindrical dandruff/collarette grade, mite eradication, and ocular comfort. Risks may include mild blurriness and mild burning following drop instillation.
Where is the study run from?
Asociación para Evitar la Ceguera en México I.A.P., Mexico
When is the study starting and how long is it expected to run for?
May 2019 to January 2020
Who is funding the study?
Tarsus Pharmaceuticals, Inc. (USA)
Who is the main contact?
Dr Roberto González Salinas, dr.gonzalezsalinas@gmail.com
Contact information
Scientific
Vicente García Torres 46
Colonia Barrio San Lucas Coyoacán
Ciudad de México
04030
Mexico
 ORCID ID |
0000-0001-6654-5191 |
|---|---|
| Phone | +52 442 219 9424 |
| dr.gonzalezsalinas@gmail.com |
Study information
| Study design | Prospective single arm open-label treatment single centre study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised study |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | No participant information sheet available |
| Scientific title | Single arm, open-label trial to evaluate the safety and efficacy of TP-03 for the treatment of blepharitis due to Demodex infestation |
| Study objectives | Treatment with TP-03 will result in a cure, defined as 2 or fewer collarettes for the upper eyelid of the analysis eye at the completion of treatment, for a statistically significant proportion of the participants. |
| Ethics approval(s) | Approved 11/05/2019, APEC Ethics Committee of the Association to Prevent Blindness in Mexico (Vicente Garcia Torres No. 46, Colonia Barrio San Lucas, Coyoacan, Ciudad de Mexico, Mexico, 04030; +55 1084 1400; comunicacion@apec.com.mx), ref: TRS-005 |
| Health condition(s) or problem(s) studied | Blepharitis due to Demodex infestation |
| Intervention | Participants will instill one drop of the active treatment solution (TP-03, 0.25%) in each eye, twice a day, morning and evening for 42 days. Participants will be seen for follow-up visits at Days 7, 14, 28 and 42. Assessments of collarettes by slit lamp examination and Demodex density, measured by lash epilation and mite counting by microscope, will be conducted at visit Days 14, 28 and 42. Safety will be determined by assessing any adverse effects related to treatment as well as assessing any changes in visual acuity and slit lamp biomicroscopy findings. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Phase II |
| Drug / device / biological / vaccine name(s) | TP-03 lotilaner ophthalmic solution 0.25% |
| Primary outcome measure | Signs of blepharitis measured using collarette grading at Days 7, 14, 28, and 42 |
| Secondary outcome measures | Demodex density measured by lash epilation and mite counting via microscope at Days 7, 14, 28, and 42 |
| Overall study start date | 11/05/2019 |
| Completion date | 20/01/2020 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 30 |
| Total final enrolment | 18 |
| Key inclusion criteria | 1. Subjects greater or equal to 18 years of age with blepharitis due to Demodex infestation 2. Willing to sign the informed consent and deemed capable of complying with the requirements of the study protocol 3. Participants must meet the following criteria in at least one eye: Have more than 10 collarettes present on the upper lid or an average Demodex density, upper and lower eyelids combined, of at least 1.5 mites per lash |
| 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. The use of lid hygiene products (lid scrubs) within the last 14 days or unwilling to forego the use of lid hygiene products during the study treatment phase 4. Contact lens wear within the last 7 days or unwilling to forego contact lens wear during the study treatment phase |
| Date of first enrolment | 11/11/2019 |
| Date of final enrolment | 25/11/2019 |
Locations
Countries of recruitment
- Mexico
Study participating centre
Colonia Barrio San Lucas Coyoacán
Ciudad de México
04030
Mexico
Sponsor information
Industry
15440 Laguna Canyon Rd.
Suite 160
Irvine
92618
United States of America
| Phone | +1 5415544415 |
|---|---|
| info@tarsusrx.com | |
| Website | https://tarsusrx.com |
Funders
Funder type
Industry
No information available
Results and Publications
| Intention to publish date | 15/12/2021 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| Publication and dissemination plan | Planned publication in a peer-reviewed journal. |
| IPD sharing plan | The current data sharing plans for this study are unknown and will be available at a later date |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | 20/08/2021 | 23/08/2021 | Yes | No |
Editorial Notes
23/08/2021: Publication reference added.
17/05/2021: Trial's existence confirmed by APEC Ethics Committee of the Association to Prevent Blindness in Mexico.
