Meibomian Gland DysfunctionPhase 2RheaNCT06054217
Effect of an Exploratory Vehicle on Meibomian Gland Dysfunction in Patients With Demodex
A Phase 2 study of Meibomian Gland Dysfunction and Demodex Infestation of Eyelid, run by Tarsus Pharmaceuticals, Inc. at 2 sites in United States.
Trial summary
The purpose of this study is to evaluate and compare the effect of two dosing regimens, BID versus TID dosing, of an Exploratory Vehicle (EV) on meibomian gland dysfunction (MGD) in patients with Demodex lid infestation. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Meibomian Gland Dysfunction, Demodex Infestation of Eyelid, Blepharitis
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Aug 2023to 15 Jun 2024
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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
- Healthy volunteers accepted
- 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
- Meets all of the following criteria in at least one eye: have more than 10 lashes with collarettes present on the upper lid; have the presence of one or more mites with lash epilation of the upper and lower lids; have evidence of meibomian gland dysfunction; have at least mild erythema of the lower lid; have a tear breakup time of less than 10 seconds; and have intact partial to full meibomian glands in at least 33% of the total meibomian gland area of the lower lid
Who cannot join
- Have used lid hygiene products within 7 days of Day 1 or unwilling to forego the use of lid hygiene products during the study
- Have used systemic antihistamines within 30 days of Day 1
- Have used artificial eyelashes, eyelash extensions, or had other cosmetic eyelash or eyelid procedures within 7 days of Day 1 or be unwilling to forego their use during the study
- Contact lens wear within 7 days of Day 1 or unwilling to forego contact lens wear for the duration of the study
- Be pregnant or lactating at Day 1
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Shultz Chang Vision
Northridge, California, 91325
Vita Eye Clinic
Shelby, North Carolina, 28150
About this study
Official title: Evaluating the Effect of Two Dosing Regimens of an Exploratory Vehicle on Meibomian Gland Dysfunction in Patients With Demodex Lid Infestation
The purpose of this study is to evaluate and compare the effect of two dosing regimens, BID versus TID dosing, of an Exploratory Vehicle (EV) on meibomian gland dysfunction (MGD) in patients with Demodex lid infestation.
Read the detailed description
This is a prospective, randomized controlled, three-arm, investigator- and interpreter-masked study. This study is intended to compare the effect of two dosing regimens of an exploratory vehicle on meibomian gland dysfunction (MGD) in participants with Demodex lid infestation. Approximately 12 participants will be enrolled in each arm. The administration period will last for approximately 85 days.
- Conditions
- Meibomian Gland Dysfunction, Demodex Infestation of Eyelid, Blepharitis, Demodectic Blepharitis
- Being tested
- Vehicle of TP-03
- Keywords
- Demodex
- Medical subject headings
- Meibomian Gland Dysfunction, Blepharitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vehicle of TP-03Drug
Also called Exploratory Vehicle
The Exploratory Vehicle is the vehicle of TP-03 (lotilaner ophthalmic solution, 0.25%)
| Study group | Role | What they receive |
|---|---|---|
| Study Cohort 1 | Experimental | Participants who were previously enrolled, dosed, and completed approximately 43 days of TID EV administration. Participants are crossed over to receive BID administration of EV for approximately 43 additional days. Receives: Drug: Vehicle of TP-03 |
| Study Cohort 2 | Experimental | Participants are randomized to receive BID administration of EV for approximately 85 days. Receives: Drug: Vehicle of TP-03 |
| Study Cohort 3 | Experimental | Participants are randomized to receive TID administration of EV for approximately 85 days Receives: Drug: Vehicle of TP-03 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment Emergent Adverse Events (TEAEs)
TEAEs related (definitely or potentially) to treatment summarized by MedDRA preferred term.
TEAEs related (definitely or potentially) to treatment summarized by MedDRA preferred term.
Measured: 85 days
Secondary outcomes (3)
Change from baseline in lower lid meibomian gland secretion score
For each of the 15 glands expressed, secretion characteristics will be graded via slit lamp examination on a scale of 0 to 3 (3=clear liquid secretion; 2=cloudy liquid secretion; 1=granularly opaque liquid secretion to inspissated/toothpaste consistency; and 0=no secretion).
Measured: 85 days
Change from baseline in lid margin erythema.
Erythema of the eyelid margin will be assessed via slit lamp examination and graded on a scale of 0 (normal) to 3 (severe) for the upper and lower eyelids of each eye.
Measured: 85 days
Change from baseline in tear breakup time assessed via slit lamp
Tear breakup time will be assessed via slit lamp examination and timed in seconds to two significant digits.
Measured: 85 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2023
- Study start1 Aug 2023
- Primary completion15 Jun 2024 (estimated)
- Study completion15 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Meibomian Gland DysfunctionStudies 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tarsus Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Mitchell C Shultz, MD, Principal investigator, Shultz Chang Vision
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06054217
- Sponsor's protocol ID
- TRS-021
- Acronym
- Rhea
- Status last verified
- Apr 2024
- First submitted
- 19 Sep 2023
- Last updated
- 9 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Effect of Two Dosing Regimens of an Exploratory Vehicle on Meibomian Gland Dysfunction in Patients With Demodex Lid Infestation
- ClinicalTrials.gov ID
- NCT06054217
- Acronym / sponsor ID
- Rhea / TRS-021
- Conditions
- Meibomian Gland Dysfunction, Demodex Infestation of Eyelid, Blepharitis, Demodectic Blepharitis
- Keywords
- Demodex
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Tarsus Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- 1 Aug 2023 (actual)
- Primary completion
- 15 Jun 2024 (estimated)
- Study completion
- 15 Jun 2024 (estimated)
- First posted
- 26 Sep 2023 (actual)
- Results
- Not posted in the source record
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 evaluate and compare the effect of two dosing regimens, BID versus TID dosing, of an Exploratory Vehicle (EV) on meibomian gland dysfunction (MGD) in patients with Demodex lid infestation.
Detailed description
This is a prospective, randomized controlled, three-arm, investigator- and interpreter-masked study. This study is intended to compare the effect of two dosing regimens of an exploratory vehicle on meibomian gland dysfunction (MGD) in participants with Demodex lid infestation. Approximately 12 participants will be enrolled in each arm. The administration period will last for approximately 85 days.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Study Cohort 1 | Experimental | Drug: Vehicle of TP-03Participants who were previously enrolled, dosed, and completed approximately 43 days of TID EV administration. Participants are crossed over to receive BID administration of EV for approximately 43 additional days. |
| Study Cohort 2 | Experimental | Drug: Vehicle of TP-03Participants are randomized to receive BID administration of EV for approximately 85 days. |
| Study Cohort 3 | Experimental | Drug: Vehicle of TP-03Participants are randomized to receive TID administration of EV for approximately 85 days |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- 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
- Meets all of the following criteria in at least one eye: have more than 10 lashes with collarettes present on the upper lid; have the presence of one or more mites with lash epilation of the upper and lower lids; have evidence of meibomian gland dysfunction; have at least mild erythema of the lower lid; have a tear breakup time of less than 10 seconds; and have intact partial to full meibomian glands in at least 33% of the total meibomian gland area of the lower lid
Key exclusion criteria (5 listed)
- Have used lid hygiene products within 7 days of Day 1 or unwilling to forego the use of lid hygiene products during the study
- Have used systemic antihistamines within 30 days of Day 1
- Have used artificial eyelashes, eyelash extensions, or had other cosmetic eyelash or eyelid procedures within 7 days of Day 1 or be unwilling to forego their use during the study
- Contact lens wear within 7 days of Day 1 or unwilling to forego contact lens wear for the duration of the study
- Be pregnant or lactating at Day 1
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 |
|---|---|---|
| Vehicle of TP-03Also: Exploratory VehicleThe Exploratory Vehicle is the vehicle of TP-03 (lotilaner ophthalmic solution, 0.25%) | Drug | Study Cohort 1, Study Cohort 2, Study Cohort 3 |
Primary outcome
Treatment Emergent Adverse Events (TEAEs)
Time frame: 85 days
TEAEs related (definitely or potentially) to treatment summarized by MedDRA preferred term. TEAEs related (definitely or potentially) to treatment summarized by MedDRA preferred term.
3 secondary outcomes
Change from baseline in lower lid meibomian gland secretion score
Time frame: 85 days
Change from baseline in lid margin erythema.
Time frame: 85 days
Change from baseline in tear breakup time assessed via slit lamp
Time frame: 85 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2024.
- 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.
Mitchell C Shultz, MD principal investigator
Shultz Chang Vision
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study of Meibomian Gland Dysfunction and Demodex Infestation of Eyelid, run by Tarsus Pharmaceuticals, Inc. at 2 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 5 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: status not confirmed, as of the sponsor's last update on 9 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this 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.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
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?
Treatment Emergent Adverse Events (TEAEs) (time frame: 85 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 Apr 2024.