BlepharitisPhase 2/3Saturn-1NCT04475432
Safety and Efficacy of TP-03 for the Treatment of Demodex Blepharitis
A Phase 2/3 study testing TP-03, 0.25% in people with Blepharitis, run by Tarsus Pharmaceuticals, Inc. at 15 sites in United States.
Trial summary
The purpose of this study is to compare the safety and efficacy of TP-03, 0.25%, an eyedrop, to its vehicle control for the treatment of blepharitis due to Demodex, a microscopic mite frequently found in human hair follicles. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Blepharitis
- What is being tested?
- TP-03, 0.25%
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 421 participants
- Where
- 15 sitesUnited States
- Study dates
- 9 Sep 2020to 4 May 2021
- Phase
- Phase 2/3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Be willing to sign the informed consent and deemed capable of complying with the requirements of the study protocol
- Meet all of the following criteria in at least one eye: Have more than 10 lashes with collarettes present on the upper lid; have at least mild erythema of the upper eyelid margin; have an average Demodex density, upper and lower eyelids combined, of 1.5 or more mites per lash
Who cannot join
- Have used lid hygiene products within 14 days of Screening or unwilling to forego the use of lid hygiene products during the study
- Have worn contact lenses within 7 days of Screening or be unwilling to forego contact lens wear during the study
- Have used artificial eyelashes or eyelash extensions within 7 days of Screening or be unwilling to forego their use during the study
- Pregnancy or lactation
Trial locations and contacts
15 sites in 1 country.
15 sites in 1 country
United States15 sites
Andover Eye Associates
Andover, Massachusetts, 01810
Midwest Cornea Associates, LLC
Carmel, Indiana, 46290
Vision Institute
Colorado Springs, Colorado, 80907
Scott & Christie and Associates, PC
Cranberry Township, Pennsylvania, 16066
Washburn Research LLC
Indianapolis, Indiana, 46240
Alpine Research Organization
Layton, Utah, 84041
The Eye Care Institute
Louisville, Kentucky, 40206
Piedmont Eye Center
Lynchburg, Virginia, 24502
Total Eye Care, P.A.
Memphis, Tennessee, 38119
Eye Research Foundation
Newport Beach, California, 92663
Visionary Eye Institute
Newport Beach, California, 92663
Cornea and Cataract Consultants of Arizona
Phoenix, Arizona, 85032
Oculus Research, Inc at EyecareCenter
Raleigh, North Carolina, 27603
Vita Eye Clinic
Shelby, North Carolina, 28150
Ophthalmology Associates
St Louis, Missouri, 63131
About this study
Official title: Randomized, Controlled, Multicenter, Double-Masked, Parallel, Phase 2b/3 Trial to Evaluate the Safety and Efficacy of TP-03 for the Treatment of Demodex Blepharitis
The purpose of this study is to compare the safety and efficacy of TP-03, 0.25%, an eyedrop, to its vehicle control for the treatment of blepharitis due to Demodex, a microscopic mite frequently found in human hair follicles. The hypothesis for the study is the proportion of participants cured at Day 43 with treatment by TP-03, 0.25%, is greater than the proportion cured by treatment with its vehicle.
Read the detailed description
This Phase 2b/3 study is a randomized, controlled, multicenter, double-masked, parallel trial to compare the safety and efficacy of TP-03, 0.25%, to vehicle control for the treatment of Demodex blepharitis. The primary objective of the study is to assess the safety and efficacy of TP-03 compared to its vehicle from Day 1 to Day 43 in adult participants with mild to severe Demodex blepharitis. The primary efficacy endpoint will be cure based upon collarettes. Safety will be determined by assessing adverse effects related to the treatment as well as evaluating any changes in visual acuity, intraocular pressure, slit lamp biomicroscopy and dilated ophthalmoscopy findings.
- Conditions
- Blepharitis
- Being tested
- TP-03, 0.25%, TP-03 Vehicle
- Keywords
- Demodex
- Medical subject headings
- Blepharitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TP-03, 0.25%Drug
Also called Lotilaner ophthalmic solution, 0.25%
TP-03, lotilaner ophthalmic solution, 0.25%, administered twice a day
TP-03 VehicleDrug
Vehicle of TP-03 ophthalmic solution, administered twice a day
| Study group | Role | What they receive |
|---|---|---|
| Active | Experimental | TP-03, lotilaner ophthalmic solution, 0.25%, administered topically twice a day for approximately 43 days Receives: Drug: TP-03, 0.25% |
| Control | Placebo comparator | Vehicle of TP-03 ophthalmic solution, administered topically twice a day for approximately 43 days Receives: Drug: TP-03 Vehicle |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of Participants Cured Based on a Collarette Score at Day 43.
The proportion of participants cured where cure is defined as 0-2 lashes with collarettes on the upper eyelid of the analysis eye.
The primary outcome analysis is the combined result from 20 analyses each with missing data imputed. Missing data were imputed per the method described in the SAP. The least square mean is computed from the result of the 20 analyses with imputed missing values.
Measured: 43 days
Secondary outcomes (2)
The Proportion of Participants With Eradication of Demodex Mites in the Analysis Eye at Day 43
The proportion of participants with Demodex mites eradicated at Day 43 where eradication is defined as a mite density of 0 mites/lash for the analysis eye. The mite density is obtained by epilating four of more lashes and dividing the number of mites observed under the microscope by the number of lashes.
The primary outcome analysis is the combined result from 20 analyses each with missing data imputed. Missing data were imputed per the method described in the SAP. The least square mean is computed from the result of the 20 analyses with imputed missing values
Measured: 43 days
Proportion of Participants Cured Based on a Composite Collarette and Erythema Score of 0 in the Analysis Eye at Day 43.
The proportion of participants cured where cure is defined as a composite of the collarettes, 0-2 lashes with collarettes on the upper eyelid of the analysis eye, and normal lid margin erythema for the upper eyelid of the analysis eye at Day 43.
The primary outcome analysis is the combined result from 20 analyses each with missing data imputed. Missing data were imputed per the method described in the SAP. The least square mean is computed from the result of the 20 analyses with imputed missing values.
Measured: 43 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2020
- Study start9 Sep 2020
- Primary completion4 May 2021
- Study completion4 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for BlepharitisStudies 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Active arm: TP-03 0.25% Control arm: Vehicle of TP-03
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 421 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tarsus Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- David Wirta, MD, Principal investigator, Eye Research Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04475432
- Sponsor's protocol ID
- TRS-009
- Acronym
- Saturn-1
- Status last verified
- Dec 2023
- First submitted
- 14 Jul 2020
- Last updated
- 21 Dec 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Yeu E, Wirta DL, Karpecki P, Baba SN, Holdbrook M; Saturn I Study Group. Lotilaner Ophthalmic Solution, 0.25%, for the Treatment of Demodex Blepharitis: Results of a Prospective, Randomized, Vehicle-Controlled, Double-Masked, Pivotal Trial (Saturn-1). Cornea. 2023 Apr 1;42(4):435-443. doi: 10.1097/ICO.0000000000003097. Epub 2022 Aug 10.
PubMed 35965392
Study at a glance
From the registry record, last updated by the sponsor on 21 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Controlled, Multicenter, Double-Masked, Parallel, Phase 2b/3 Trial to Evaluate the Safety and Efficacy of TP-03 for the Treatment of Demodex Blepharitis
- ClinicalTrials.gov ID
- NCT04475432
- Acronym / sponsor ID
- Saturn-1 / TRS-009
- Conditions
- Blepharitis
- Keywords
- Demodex
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 421 participants (actual)
- Lead sponsor
- Tarsus Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- 9 Sep 2020 (actual)
- Primary completion
- 4 May 2021 (actual)
- Study completion
- 4 May 2021 (actual)
- First posted
- 17 Jul 2020 (actual)
- Results
- Posted 21 Dec 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to compare the safety and efficacy of TP-03, 0.25%, an eyedrop, to its vehicle control for the treatment of blepharitis due to Demodex, a microscopic mite frequently found in human hair follicles. The hypothesis for the study is the proportion of participants cured at Day 43 with treatment by TP-03, 0.25%, is greater than the proportion cured by treatment with its vehicle.
Detailed description
This Phase 2b/3 study is a randomized, controlled, multicenter, double-masked, parallel trial to compare the safety and efficacy of TP-03, 0.25%, to vehicle control for the treatment of Demodex blepharitis. The primary objective of the study is to assess the safety and efficacy of TP-03 compared to its vehicle from Day 1 to Day 43 in adult participants with mild to severe Demodex blepharitis. The primary efficacy endpoint will be cure based upon collarettes. Safety will be determined by assessing adverse effects related to the treatment as well as evaluating any changes in visual acuity, intraocular pressure, slit lamp biomicroscopy and dilated ophthalmoscopy findings.
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
- Active arm: TP-03 0.25% Control arm: Vehicle of TP-03
| Arm | Type | Receives |
|---|---|---|
| Active | Experimental | Drug: TP-03, 0.25%TP-03, lotilaner ophthalmic solution, 0.25%, administered topically twice a day for approximately 43 days |
| Control | Placebo comparator | Drug: TP-03 VehicleVehicle of TP-03 ophthalmic solution, administered topically twice a day for approximately 43 days |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Be willing to sign the informed consent and deemed capable of complying with the requirements of the study protocol
- Meet all of the following criteria in at least one eye: Have more than 10 lashes with collarettes present on the upper lid; have at least mild erythema of the upper eyelid margin; have an average Demodex density, upper and lower eyelids combined, of 1.5 or more mites per lash
Key exclusion criteria (4 listed)
- Have used lid hygiene products within 14 days of Screening or unwilling to forego the use of lid hygiene products during the study
- Have worn contact lenses within 7 days of Screening or be unwilling to forego contact lens wear during the study
- Have used artificial eyelashes or eyelash extensions within 7 days of Screening or be unwilling to forego their use during the study
- Pregnancy or lactation
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 |
|---|---|---|
| TP-03, 0.25%Also: Lotilaner ophthalmic solution, 0.25%TP-03, lotilaner ophthalmic solution, 0.25%, administered twice a day | Drug | Active |
| TP-03 VehicleVehicle of TP-03 ophthalmic solution, administered twice a day | Drug | Control |
Primary outcome
Proportion of Participants Cured Based on a Collarette Score at Day 43.
Time frame: 43 days
The proportion of participants cured where cure is defined as 0-2 lashes with collarettes on the upper eyelid of the analysis eye. The primary outcome analysis is the combined result from 20 analyses each with missing data imputed. Missing data were imputed per the method described in the SAP. The least square mean is computed from the result of the 20 analyses with imputed missing values.
2 secondary outcomes
The Proportion of Participants With Eradication of Demodex Mites in the Analysis Eye at Day 43
Time frame: 43 days
Proportion of Participants Cured Based on a Composite Collarette and Erythema Score of 0 in the Analysis Eye at Day 43.
Time frame: 43 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Dec 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 35965392Yeu E, Wirta DL, Karpecki P, Baba SN, Holdbrook M; Saturn I Study Group. Lotilaner Ophthalmic Solution, 0.25%, for the Treatment of Demodex Blepharitis: Results of a Prospective, Randomized, Vehicle-Controlled, Double-Masked, Pivotal Trial (Saturn-1). Cornea. 2023 Apr 1;42(4):435-443. doi: 10.1097/ICO.0000000000003097. Epub 2022 Aug 10.
- Individual participant dataSharing planned: No
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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.
David Wirta, MD principal investigator
Eye Research Foundation
15 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing TP-03, 0.25% in people with Blepharitis, run by Tarsus Pharmaceuticals, Inc. at 15 sites in United States.
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 2 inclusion and 4 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 21 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in United States. 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 combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 21 Dec 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Proportion of Participants Cured Based on a Collarette Score at Day 43. (time frame: 43 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04475432, which also lists 1 linked publication.
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 21 Dec 2023.