Long-term safety of TP-03 treatment for Demodex blepharitis
| ISRCTN | ISRCTN49009434 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN49009434 |
| Secondary identifying numbers | TRS-011 |
- Submission date
- 02/03/2021
- Registration date
- 09/03/2021
- Last edited
- 09/03/2021
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Eye Diseases
Plain English summary of protocol
Background and study aims
Chronic blepharitis is eye inflammation that mainly involves the eyelid margin and is a common cause of chronic eye irritation. Blepharitis may affect the eyelid skin, base of the eyelashes, the eyelash follicles, the meibomian glands and gland orifices. The presence of the mite Demodex folliculorum in the eyelid structures of humans has been recognized for more than a century and has been implicated as a cause of chronic blepharitis. This study is designed to assess the long-term safety of the use of TP-03, 0.25% or its vehicle for the treatment of Demodex blepharitis.
Who can participate?
Patients aged 18 or older who have blepharitis due to Demodex infestation
What does the study involve?
Up to 418 participants who completed treatment with TP-03, 0.25% or its vehicle for 43 days will be invited to participate in this observational study. No treatment will be given in this study. Safety will be determined by assessing adverse events as well as evaluating any changes in eye tests.
What are the possible benefits and risks of participating?
This is an observational study and no treatment will be given. Participants may not receive any direct benefit. Possible risks include the dye used for the eye test causing mild irritation and temporary color changes to the tears and mucous. The eye tests may also cause mild irritation to the eye surface and temporary blurred vision, and there is a rare risk of an allergic reaction to the topical anesthetic.
Where is the study run from?
Ora, Inc. (USA)
When is the study starting and how long is it expected to run for?
July 2020 to February 2022
Who is funding the study?
Tarsus Pharmaceuticals, Inc. (USA)
Who is the main contact?
Yesha Raval
yraval@oraclinical.com
Contact information
Public
300 Brickstone Square
Andover
01810
United States of America
| Phone | +1 (0)978 685 8900 |
|---|---|
| yraval@oraclinical.com |
Scientific
15440 Laguna Canyon Road
Suite 160
Irvine
92618
United States of America
| Phone | +1 (0)510 435 0090 |
|---|---|
| stephanie@tarsusrx.com |
Study information
| Study design | Multicenter observational study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Longitudinal study |
| Study setting(s) | Other |
| Study type | Treatment |
| Participant information sheet | No participant information sheet available |
| Scientific title | Extended observational trial to evaluate the long-term safety of TP-03 following acute treatment for Demodex blepharitis |
| Study objectives | The Saturn-1 extension study is an observational study to evaluate the long-term safety of acute administration of TP-03, 0.25% for the treatment of Demodex blepharitis. |
| Ethics approval(s) | Approved 11/01/2021, Alpha IRB (1001 Avenida Pico, Suite C, #497, San Clemente, CA 92673, USA; +1(0)949 542 3882; info@alphairb.com), ref: 11-Jan-2021 |
| Health condition(s) or problem(s) studied | Blepharitis due to Demodex infestation |
| Intervention | A post-treatment observational study to follow participants who were previously treated for 43 days with TP-03, 0.25% or its vehicle. Participants will be assessed at 180 and 365 days following the initiation and completion of treatment in order to assess the long-term safety of acute administration of TP-03, 0.25% for the treatment of Demodex blepharitis. Safety will be determined by assessing adverse events as well as evaluating any changes in visual acuity, slit-lamp biomicroscopy including an assessment of corneal staining, intraocular pressure and a dilated fundus examination. No treatment will be administered in this study. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | TP-03 |
| Primary outcome measure | Adverse events assessed using participant response to non-specific queries, spontaneous participant reports and investigator observations at Day 180 and Day 365 |
| Secondary outcome measures | Measured at baseline, Day 180 and Day 365: 1. Visual acuity measured using ETDRS-Fast method 2. Anterior segment health assessed using slit-lamp biomicroscopy 3. Intraocular pressure measured using applanation tonometry 4. Posterior segment health assessed using dilated fundus examination |
| Overall study start date | 02/07/2020 |
| Completion date | 28/02/2022 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Mixed |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 418 |
| Key inclusion criteria | 1. Male or female, aged ≥18 years of age 2. Participants must have been treated with TP-03 or the vehicle of TP-03 for 43 days 3. Be willing to sign IRB-approved informed consent and deemed capable of complying with the requirements of the study protocol 4. Be willing to forego participation in any clinical trial with an investigational drug or device during the observational study |
| Key exclusion criteria | The investigator has the right to exclude any individual from participating in the study if s/he deems it in the best interest of the participant or if the participant’s enrollment could impact data validity |
| Date of first enrolment | 02/03/2021 |
| Date of final enrolment | 31/08/2021 |
Locations
Countries of recruitment
- United States of America
Study participating centres
Newport Beach
92663
United States of America
Andover
01810
United States of America
Carmel
46290
United States of America
Louisville
40206
United States of America
Lynchburg
24502
United States of America
Phoenix
85032
United States of America
Shelby
28150
United States of America
Raleigh
27603
United States of America
Colorado Springs
80907
United States of America
Memphis
38119
United States of America
Cranberry Township
16066
United States of America
Newport Beach
92663
United States of America
St. Louis
63131
United States of America
Indianapolis
46240
United States of America
Layton
84041
United States of America
Sponsor information
Industry
15440 Laguna Canyon Road
Ste 160
Irvine
92618
United States of America
| Phone | +1 (0)9494099820 |
|---|---|
| info@tarsusrx.com | |
| Website | https://tarsusrx.com/ |
Funders
Funder type
Industry
No information available
Results and Publications
| Intention to publish date | 28/02/2023 |
|---|---|
| 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. No additional documents are or will be available. |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are not expected to be made available as this is data for an investigational product that has not yet been submitted to a regulatory authority. |
Editorial Notes
09/03/2021: Trial's existence confirmed by Alpha IRB.
