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Trial registered on ANZCTR


Registration number
ACTRN12620000320954
Ethics application status
Approved
Date submitted
25/12/2019
Date registered
9/03/2020
Date last updated
19/11/2020
Date data sharing statement initially provided
9/03/2020
Date results information initially provided
19/11/2020
Type of registration
Retrospectively registered

Titles & IDs
Public title
Study Evaluating a New Drug to Treat Participants with Eyelid Inflammation Related to a Parasite (Demodex)
Scientific title
Randomized, Controlled, Double-Blind, Parallel Trial to Evaluate the Safety and Efficacy of TP- 03 for the Treatment of Blepharitis Due to Demodex Infestation
Secondary ID [1] 299931 0
TRS-006
Universal Trial Number (UTN)
U1111-1244-6570
Trial acronym
Europa Study
Linked study record
None

Health condition
Health condition(s) or problem(s) studied:
Blepharitis 315366 0
Blepharitis due to Demodex infestation 315367 0
Condition category
Condition code
Eye 313668 313668 0 0
Diseases / disorders of the eye

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
One drop of 0.25% TP-03 topical ophthalmic preparation administered twice daily to both eyes for 42 days. At every follow-up visit, the site will ask the participant to evaluate drop comfort to help assess compliance. At the Day 42 visit, participants will be asked to return the eye drop bottle.
Intervention code [1] 316199 0
Treatment: Drugs
Comparator / control treatment
One drop of vehicle of TP-03 topical ophthalmic preparation administered twice daily to both eyes for 42 days. At every follow-up visit, the site will ask the participant to evaluate drop comfort to help assess compliance. At the Day 42 visit, participants will be asked to return the eye drop bottle.
Control group
Placebo

Outcomes
Primary outcome [1] 322093 0
% of participants with a mite density (average number of mites per lash) of 0 in active versus control group upon lash epilation and mite counting via microscope
Timepoint [1] 322093 0
42 days post commencement of intervention
Primary outcome [2] 322099 0
% of participants with a cylindrical dandruff grade of 0 in active versus control group upon slit lamp biomicroscopy examination
Timepoint [2] 322099 0
42 days post commencement of intervention
Primary outcome [3] 322100 0
Treatment-related adverse events such as eye drop discomfort as reported in a study-specific questionnaire
Timepoint [3] 322100 0
1, 7, 14, 28, and 42 days after intervention commencement
Secondary outcome [1] 377328 0
% of participants with a mite density (average number of mites per lash) of 0 in active versus control group upon lash epilation and mite counting via microscope
Timepoint [1] 377328 0
14 and 28 days post commencement of intervention
Secondary outcome [2] 377428 0
% of participants with a cylindrical dandruff grade of 0 in active versus control group upon slit lamp biomicroscopy examination
Timepoint [2] 377428 0
7, 14, and 28 days post commencement of intervention

Eligibility
Key inclusion criteria
Participants must meet all of the following criteria in at least one eye:
- More than 10 cylindrical dandruff present on the upper lid
- Mild to severe upper eyelid margin erythema
- Average Demodex density, upper and lower eyelids combined, of 1.5 mites or more per eyelash
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Systemic or topical antibacterial, antiparasitic or anti-inflammatory steroid treatment within the last 14 days
- Topical tea tree oil or hypochlorous acid treatment of the ophthalmic area within the last 14 days
- The 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Numbered eye drop bottles
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Permuted block randomisation
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Prospective
Phase
Phase 2
Type of endpoint(s)
Safety/efficacy
Statistical methods / analysis
Based on a previous randomized controlled study with TP 03 compared to vehicle control, a sample size of 60 participants, 30 per treatment group, should provide greater than 80% power for both the primary and secondary efficacy endpoints.

Efficacy measures will be analyzed using a one-sided Fisher’s exact-test comparing the proportions between treatment groups using an a of 0.025. Safety measures will be summarized for each treatment group using descriptive statistics.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 22148 0
Mexico
State/province [1] 22148 0
Mexico City

Funding & Sponsors
Funding source category [1] 304391 0
Commercial sector/Industry
Name [1] 304391 0
Tarsus Pharmaceuticals
Address [1] 304391 0
19782 MacArthur Blvd., Suite 285
Irvine, CA 92612
Country [1] 304391 0
United States of America
Primary sponsor type
Individual
Name
Roberto González Salinas, MD
Address
Asociación para Evitar la Ceguera (APEC) Departamento de Investigación
Vicente García Torres 46, Colonia Barrio San Lucas Coyoacán, Ciudad de México 04030
Country
Mexico
Secondary sponsor category [1] 304650 0
None
Name [1] 304650 0
Address [1] 304650 0
Country [1] 304650 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 304829 0
Comité de Ética en Investigación de la Asociación para Evitar la Ceguera en México I.A.P.
Ethics committee address [1] 304829 0
Ethics and Research Committee, Asociación para Evitar la Ceguera en México I.A.P.
Vicente García Torres 46, Colonia Barrio San Lucas Coyoacán, Ciudad de México 04030
Ethics committee country [1] 304829 0
Mexico
Date submitted for ethics approval [1] 304829 0
08/11/2019
Approval date [1] 304829 0
03/12/2019
Ethics approval number [1] 304829 0
INV-19-06

Summary
Brief summary
The purpose of this study is to evaluate the safety and efficacy of a new eye drop, 0.25% TP-03, for the treatment of eyelid inflammation due to a parasitic (Demodex) infestation compared to vehicle control.

Study hypothesis: Treatment with TP-03 will result in a significantly greater proportion of participants with Grade 0 cylindrical dandruff and with their Demodex infestation eradicated at Day 42 compared to the vehicle control. Any ocular irritation experienced will be mild and similar to the vehicle control in frequency and severity.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 98342 0
Dr Roberto González Salinas
Address 98342 0
Asociación para Evitar la Ceguera (APEC) Departamento de Investigación
Vicente García Torres 46, Colonia Barrio San Lucas Coyoacán, Ciudad de México, México 04030
Country 98342 0
Mexico
Phone 98342 0
+52 5556596572
Fax 98342 0
Email 98342 0
dr.gonzalezsalinas@gmail.com
Contact person for public queries
Name 98343 0
Ms Yoko Burgoa
Address 98343 0
Asociación para Evitar la Ceguera (APEC) Departamento de Investigación
Vicente García Torres 46, Colonia Barrio San Lucas Coyoacán, Ciudad de México, México 04030
Country 98343 0
Mexico
Phone 98343 0
+52 5510841400
Fax 98343 0
Email 98343 0
yoko.burgoa@apec.com.mx
Contact person for scientific queries
Name 98344 0
Dr Roberto González Salinas
Address 98344 0
Asociación para Evitar la Ceguera (APEC) Departamento de Investigación
Vicente García Torres 46, Colonia Barrio San Lucas Coyoacán, Ciudad de México, México 04030
Country 98344 0
Mexico
Phone 98344 0
+52 5556596572
Fax 98344 0
Email 98344 0
dr.gonzalezsalinas@gmail.com

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Age, sex, treatment arm, Demodex density by visit and collarette grade by visit
When will data be available (start and end dates)?
Immediately following publication and ending three years after publication
Available to whom?
Case-by-case basis at the discretion of the Primary Sponsor
Available for what types of analyses?
For IPD meta-analyses
How or where can data be obtained?
Data can be obtained from the Principal Investigator who can be contacted by email at dr.gonzalezsalinas@gmail.com.
What supporting documents are/will be available?
No other documents available
Summary results
Have study results been published in a peer-reviewed journal?
No
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary