Demodex BlepharitisPhase 4ArielNCT06182358
Impact of XDEMVY® on Demodex Blepharitis in Soft Contact Lens Wearers
A Phase 4 study testing Lotilaner ophthalmic solution, 0.25% in people with Demodex Blepharitis, run by Tarsus Pharmaceuticals, Inc. at 14 sites in United States.
Trial summary
To compare the efficacy of XDEMVY ophthalmic drop to its vehicle control for the treatment of Demodex blepharitis and its impact on the soft contact lens wearing experience. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Demodex Blepharitis
- What is being tested?
- Lotilaner ophthalmic solution, 0.25%
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 145 participants
- Where
- 14 sitesUnited States
- Study dates
- 27 Dec 2023to 27 Jan 2025
- Phase
- Phase 4
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Be willing to sign the informed consent form and is deemed capable of complying with the requirements of the study protocol
- Must meet the following criteria in at least one eye: Have more than 10 eyelashes (Grade 2 or higher) with collarettes on the upper or lower eyelid; have at least Grade 1 erythema of the lower eyelid; and have a total meibomian gland secretion score ≥ 12 but ≤ 32 AND have a minimum of 6 expressible glands for the 15 glands evaluated on the lower eyelid
- Currently wearing soft contact lenses on both eyes an average of at least 2 days per week with an average minimum wearing time of 6 hours each day over the past 3 months and is able and willing to continue to wear contact lenses during the study
Who cannot join
- Use of artificial tears or rewetting drops within 24 hours of the Screening visit or unwilling to forego the use of this treatment during the study
- Prescription AND systemic, drug delivery implant, ocular topical, or topical: antibacterial, anti-parasitic, or anti-inflammatory corticosteroid treatment within 14 days of the Screening or Day 1 visits
- Use of TYRVAYA™ Nasal Spray (varenicline solution, Oyster Point Pharma) within 14 days of the Screening visit or unwilling to forego the use of this treatment during the study
- Use of XDEMVY™ (lotilaner ophthalmic solution) 0.25%, Tarsus Pharmaceuticals, Inc., within 12 months of the Screening visit
- Treatment for blepharitis (e.g., tea tree oil-based products, hypochlorous acid-based products, commercial eyelid foams, eyelid wipes, lid scrubs, etc.) within 14 days of the Screening visit or unwilling to forego the use of these treatments during the study
- Use of artificial eyelashes or eyelash extensions at the Screening visit if they limit accurate eyelid margin assessment
- Currently pregnant or lactating
Trial locations and contacts
14 sites in 1 country.
14 sites in 1 country
United States14 sites
Site
Cave Creek, Arizona, 85331
Vision Institute
Colorado Springs, Colorado, 80907
Site
Cranberry Township, Pennsylvania, 16066
Site
Delray Beach, Florida, 33484
Site
Edina, Minnesota, 55436
Site
Fargo, North Dakota, 58103
Site
Houston, Texas, 77005
Site
Indianapolis, Indiana, 46240
Site
Long Beach, California, 90805
Site
Louisville, Kentucky, 40206
Site
Memphis, Tennessee, 38104
Site
Pittsburg, Kansas, 66762
Site
Powell, Ohio, 43065
Site
Shelby, North Carolina, 28150
About this study
Official title: Randomized Controlled Trial to Evaluate the Impact of XDEMVY® on Demodex Blepharitis in Soft Contact Lens Wearers
To compare the efficacy of XDEMVY ophthalmic drop to its vehicle control for the treatment of Demodex blepharitis and its impact on the soft contact lens wearing experience.
Read the detailed description
This Phase 4 study is a prospective, multicenter, randomized, vehicle-controlled, double-masked, two-arm, parallel treatment clinical trial of participants who have Demodex blepharitis and are current daily wear soft contact lenses wearers. The primary outcome measure is the reduction of collarettes at Day 43. The secondary outcome measures are the reduction of eyelid margin erythema at Day 43; subject-reported comfortable contact lens daily wear time; and total contact lens wear time. Safety will be determined by assessing adverse effects related to study drug administration as well as evaluating any clinically significant changes from baseline in visual acuity and slit lamp biomicroscopy findings.
- Conditions
- Demodex Blepharitis
- Being tested
- Lotilaner ophthalmic solution, 0.25%, Vehicle control
- Keywords
- Soft contact lenses
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lotilaner ophthalmic solution, 0.25%Drug
XDEMVY (lotilaner ophthalmic solution) 0.25%, administered topically twice a day for approximately 43 days
Vehicle controlDrug
Vehicle of XDEMVY administered topically twice a day for approximately 43 days
| Study group | Role | What they receive |
|---|---|---|
| Active Treatment | Experimental | XDEMVY (lotilaner ophthalmic solution) 0.25%, administered topically twice a day for approximately 43 days Receives: Drug: Lotilaner ophthalmic solution, 0.25% |
| Control | Placebo comparator | Vehicle of XDEMVY ophthalmic solution, administered topically twice a day for approximately 43 days Receives: Drug: Vehicle control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction of collarettes at Day 43
Change in collarette score at Day 43 compared to baseline, graded from 0 (0 to 2 lashes have collarettes per eyelid) to 4 ( 2/3 or more of lashes have collarettes per eyelid)
Measured: 43 days
Secondary outcomes (3)
Reduction of eyelid margin erythema at Day 43
Change in eyelid margin erythema score at Day 43 compared to baseline, graded from 0 (normal) to 3 (severe)
Measured: 43 days
Subject-reported comfortable daily wear time
Comfortable daily wear time in hours per day
Measured: 43 days
Total contact lens wear time
Total daily wear time in hours per day
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 posted26 Dec 2023
- Study start27 Dec 2023
- Primary completion27 Jan 2025
- Study completion27 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Demodex 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Active arm: XDEMVY 0.25% Control arm: Vehicle of XDEMVY
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 145 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tarsus Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Blake Simmons, OD, Principal investigator, Vision Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06182358
- Sponsor's protocol ID
- TRS-023
- Acronym
- Ariel
- Status last verified
- Jun 2025
- First submitted
- 13 Dec 2023
- Last updated
- 2 Jul 2025
- 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 2 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial to Evaluate the Impact of XDEMVY® on Demodex Blepharitis in Soft Contact Lens Wearers
- ClinicalTrials.gov ID
- NCT06182358
- Acronym / sponsor ID
- Ariel / TRS-023
- Conditions
- Demodex Blepharitis
- Keywords
- Soft contact lenses
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 145 participants (actual)
- Lead sponsor
- Tarsus Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- 27 Dec 2023 (actual)
- Primary completion
- 27 Jan 2025 (actual)
- Study completion
- 27 Jan 2025 (actual)
- First posted
- 26 Dec 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.
To compare the efficacy of XDEMVY ophthalmic drop to its vehicle control for the treatment of Demodex blepharitis and its impact on the soft contact lens wearing experience.
Detailed description
This Phase 4 study is a prospective, multicenter, randomized, vehicle-controlled, double-masked, two-arm, parallel treatment clinical trial of participants who have Demodex blepharitis and are current daily wear soft contact lenses wearers. The primary outcome measure is the reduction of collarettes at Day 43. The secondary outcome measures are the reduction of eyelid margin erythema at Day 43; subject-reported comfortable contact lens daily wear time; and total contact lens wear time. Safety will be determined by assessing adverse effects related to study drug administration as well as evaluating any clinically significant changes from baseline in visual acuity and slit lamp biomicroscopy 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: XDEMVY 0.25% Control arm: Vehicle of XDEMVY
| Arm | Type | Receives |
|---|---|---|
| Active Treatment | Experimental | Drug: Lotilaner ophthalmic solution, 0.25%XDEMVY (lotilaner ophthalmic solution) 0.25%, administered topically twice a day for approximately 43 days |
| Control | Placebo comparator | Drug: Vehicle controlVehicle of XDEMVY ophthalmic solution, administered topically twice a day for approximately 43 days |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Be willing to sign the informed consent form and is deemed capable of complying with the requirements of the study protocol
- Must meet the following criteria in at least one eye: Have more than 10 eyelashes (Grade 2 or higher) with collarettes on the upper or lower eyelid; have at least Grade 1 erythema of the lower eyelid; and have a total meibomian gland secretion score ≥ 12 but ≤ 32 AND have a minimum of 6 expressible glands for the 15 glands evaluated on the lower eyelid
- Currently wearing soft contact lenses on both eyes an average of at least 2 days per week with an average minimum wearing time of 6 hours each day over the past 3 months and is able and willing to continue to wear contact lenses during the study
Key exclusion criteria (7 listed)
- Use of artificial tears or rewetting drops within 24 hours of the Screening visit or unwilling to forego the use of this treatment during the study
- Prescription AND systemic, drug delivery implant, ocular topical, or topical: antibacterial, anti-parasitic, or anti-inflammatory corticosteroid treatment within 14 days of the Screening or Day 1 visits
- Use of TYRVAYA™ Nasal Spray (varenicline solution, Oyster Point Pharma) within 14 days of the Screening visit or unwilling to forego the use of this treatment during the study
- Use of XDEMVY™ (lotilaner ophthalmic solution) 0.25%, Tarsus Pharmaceuticals, Inc., within 12 months of the Screening visit
- Treatment for blepharitis (e.g., tea tree oil-based products, hypochlorous acid-based products, commercial eyelid foams, eyelid wipes, lid scrubs, etc.) within 14 days of the Screening visit or unwilling to forego the use of these treatments during the study
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 |
|---|---|---|
| Lotilaner ophthalmic solution, 0.25%XDEMVY (lotilaner ophthalmic solution) 0.25%, administered topically twice a day for approximately 43 days | Drug | Active Treatment |
| Vehicle controlVehicle of XDEMVY administered topically twice a day for approximately 43 days | Drug | Control |
Primary outcome
Reduction of collarettes at Day 43
Time frame: 43 days
Change in collarette score at Day 43 compared to baseline, graded from 0 (0 to 2 lashes have collarettes per eyelid) to 4 ( 2/3 or more of lashes have collarettes per eyelid)
3 secondary outcomes
Reduction of eyelid margin erythema at Day 43
Time frame: 43 days
Subject-reported comfortable daily wear time
Time frame: 43 days
Total contact lens wear time
Time frame: 43 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2025.
- 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.
Blake Simmons, OD principal investigator
Vision Institute
14 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Lotilaner ophthalmic solution, 0.25% in people with Demodex Blepharitis, run by Tarsus Pharmaceuticals, Inc. at 14 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 3 inclusion and 7 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 2 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 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 phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Reduction of collarettes 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?
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 2 Jul 2025.