Demodex BlepharitisPhase 4NCT07561450
Demodex Blepharitis in Scleral Lens Wearers
A Phase 4 study testing Xdemvy in people with Demodex Blepharitis, run by Boston Sight at 1 site in United States.
Trial summary
The purpose of this study will be to see if Xdemvy (lotilaner ophthalmic solution) 0.25% has a positive impact on ocular surface symptoms and PROSE device functionality and performance. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Demodex Blepharitis
- What is being tested?
- Xdemvy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Apr 2026to 20 Oct 2026
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Written Informed Consent has been obtained prior to any study-related procedures taking place
- Subject is Male or Female, 18 years of age or older prior to the initial visit
- Is an established wearer of PROSE devices for > 6 months in both eyes
- Currently wears PROSE devices on a daily basis in both eyes
- No plans to alter the PROSE lens design in either eye during the study period
- Bilateral Demodex Blepharitis (> Grade 2, which is more than 10 upper lash collarettes, worse eye)
Show all 10Show fewer
- Baseline CLDEQ-8 score of 12 or higher
- Baseline VAS score of 40 or above for frequency OR severity in ONE of the following:
- tolerability, blurred vision, ocular burning, ocular redness or ocular itching 9. In the opinion of the investigator, the subject can follow study instructions 10. In the opinion of the investigator, the subject can complete all study procedures and visits
- -
Who cannot join
- Is currently participating in any other type of eye-related clinical research study
- Is pregnant or nursing as reported by the subject.
- Has a condition or is in a situation which, in the investigator's opinion, may put the subject at significant risk, may confound study outcomes, or may significantly interfere with the subject's participation in the study.
- Has had previous ocular surgery within the past 12 weeks or has planned ocular surgery during the study period.
- Has initiated any new blepharitis or ocular surface treatment within the last 12 weeks
- The subject is only wearing a PROSE device in one eye.
Show all 11Show fewer
- The participant is monocular
- The participant carries a diagnosis of glaucoma or ocular hypertension or glaucoma suspect AND is currently using glaucoma medications
- Allergy to sodium fluorescein
- Allergy to XDEMVY (lotilaner ophthalmic solution) 0.25%
- -
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study will be to see if Xdemvy (lotilaner ophthalmic solution) 0.25% has a positive impact on ocular surface symptoms and PROSE device functionality and performance.
The investigators hypothesize the use of Xdemvy in subjects utilizing PROSE treatment will be well tolerated and that the reduction in Demodex mite load on the eyelid margin will result in reduced ocular surface symptoms and improved PROSE tolerance and functionality.
Read the detailed description
This proof-of-concept study will investigate whether standard, on label, six-week treatment of Demodex Blepharitis (DB) with Xdemvy (lotilaner ophthalmic solution) 0.25% has a positive impact on ocular surface symptoms and PROSE device functionality and performance. The investigators hypothesize the use of Xdemvy in subjects utilizing PROSE treatment will be well tolerated and that the reduction in Demodex mite load (measured utilizing the surrogate, validated endpoint of lash collarettes 6,7) on the eyelid margin will result in reduced ocular surface symptoms and improved PROSE tolerance and functionality.
A total of up to SIX subjects with bilateral Demodex Blepharitis (> Grade 2, which is more than 10 collarettes of upper lash, in the worse eye) in a single clinic setting who currently wear scleral lenses on a daily basis for irregular corneas and/or ocular surface disease will be offered enrollment and will be included in the study The total duration of a subjects' participation in the study will be approximately 6 weeks.
Visit 1: Screening Visit [in person]:
- Completion of informed consent
- Review inclusion/exclusion criteria
- Collect age, sex, race, ethnicity, social history (drug, alcohol and smoking), medical history, past ocular history, past ocular surgical history (including ocular and refractive surgery), allergies, medications, habitual contact lens use.
- Symptom Questionnaires:
- Baseline questions b. Contact Lens Dry Eye Questionnaire-8 (CLDEQ-8) c. Visual Analog Scale (VAS) questions assessing: i. Tolerability for desired daily PROSE wear time ii. Fluctuating vision iii. Ocular Burning iv. Ocular Redness v. Ocular Itching e. Clinical Examinations:
- Best-Corrected Distance Visual Acuity (LogMAR)
- Slit Lamp Examination
- Collarette Scale (used in Saturn-1 and Saturn-2 clinical trials)
- Imaging:
- Standardized photographs of the upper and lower eyelids will be obtained. g. Diary
- Daily subject diaries will be dispensed to subjects. Subjects will collect - i. PROSE device wear times (hours of wear each day) ii. Document each PROSE device application and removal
- Document reason for removal iii. Document each dose instillation of Xdemvy iv. Document daily artificial tear use h. Dispense Xdemvy (lotilaner ophthalmic solution) 0.25% with instructions for use: one drop both eyes twice a day for 6 weeks. PROSE lenses should be removed prior to instillation of Xdemvy and may be reinserted 15 minutes following administration.8 Visit 2: Day 21 [3 day pre/post visit window] - Phone call
- Update: medical and ocular history, surgical history, social history, medications, allergies b. Review compliance with protocol c. Symptom Questionnaire:
- Contact Lens Dry Eye Questionnaire-8 (CLDEQ-8) d. Diary
- Reminder to complete daily diary Visit 3: Day 42 [7 day pre/post visit window] (In-person)
- Update: medical and ocular history, surgical history, social history, medications, allergies
- Review compliance with protocol
- Symptom Questionnaires:
- Contact Lens Dry Eye Questionnaire-8 (CLDEQ-8) b. Visual Analog Scale (VAS) questions assessing: i. Tolerability for desired daily PROSE wear time ii. Fluctuating vision iii. Ocular Burning iv. Ocular Redness v. Ocular Itching d. Clinical Examinations:
- Best-Corrected Distance Visual Acuity (LogMAR) b. Slit Lamp Examination c. Collarette Scale (used in Saturn-1 and Saturn-2 clinical trials) e. Imaging:
- Standardized photographs of the upper and lower eyelids will be obtained. f. Diary
- Collection g. Medication
- Collection
- Conditions
- Demodex Blepharitis
- Being tested
- Xdemvy
- Keywords
- Blepharitis
- Medical subject headings
- Blepharitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
XdemvyDrug
All subjects enrolled inthis study will be treated with xdemvy
| Study group | Role | What they receive |
|---|---|---|
| Patients identified as having Demodex Blepharitis | Experimental | This study has one arm which is the treatment arm Receives: Drug: Xdemvy |
What is being measured
The primary outcome is the main question the study is designed to answer.
1. The Contact Lens Dry Eye Questionnaire-8 (CLDEQ-8)
The Contact Lens Dry Eye Questionnaire-8 (CLDEQ-8) is a validated 8-item, self-report tool developed by Chalmers et al. in 2012 to assess the frequency and intensity of soft contact lens (SCL) discomfort and dryness. A total score of \(\ge 12\) indicates clinically significant discomfort and potential, which are strong predictors of patient dropout.
Measured: Visit 1 - screening visit, Visit 2 - day 21, and Visit 3 - day 42
2. Visual analog scale (VAS) - Symptom and Lens Performance Scores
A Visual Analog Scale (VAS) is a subjective measurement tool, where individuals mark their symptom intensity (like pain, burning, or itching) to capture a continuous feeling not easily measured numerically. It's simple, widely used in healthcare for assessing symptom severity and treatment effectiveness, and recorded by measuring the distance from the "no" end, typically 0-100 mm. Subjects will complete VAS scales for Tolerability for desired daily PROSE wear time, Fluctuating vision, Ocular Burning, Ocular Redness, and Ocular Itching.
Measured: Visit 1 - screening and Visit 3 - day 42
Secondary outcomes (1)
Collarette grade
A collarette grade is a clinical, non-linear scoring system (typically 0-4) used to quantify the severity of Demodex blepharitis by counting cylindrical dandruff-like debris (collarettes) at the base of eyelashes. It measures the infestation level, with higher grades indicating a higher percentage of lashes affected.
Measured: Visit 1 - screening and Visit 3 - day 42
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2026
- Study start27 Apr 2026
- Primary completion20 Oct 2026
- Study completion20 Oct 2026
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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston Sight
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Daniel C Brocks, Boston Sight
- Investigators
- Daniel Brocks, MD, Principal investigator, Boston Sight
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07561450
- Sponsor's protocol ID
- BFS-Xdemvy-01
- Status last verified
- Oct 2026
- First submitted
- 14 Apr 2026
- Last updated
- 22 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Demodex Blepharitis in Scleral Lens Wearers
- ClinicalTrials.gov ID
- NCT07561450
- Acronym / sponsor ID
- BFS-Xdemvy-01
- Conditions
- Demodex Blepharitis
- Keywords
- Blepharitis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Boston SightUniversity, hospital or other
- Study start
- 27 Apr 2026 (actual)
- Primary completion
- 20 Oct 2026 (actual)
- Study completion
- 20 Oct 2026 (actual)
- First posted
- 1 May 2026 (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 will be to see if Xdemvy (lotilaner ophthalmic solution) 0.25% has a positive impact on ocular surface symptoms and PROSE device functionality and performance.
The investigators hypothesize the use of Xdemvy in subjects utilizing PROSE treatment will be well tolerated and that the reduction in Demodex mite load on the eyelid margin will result in reduced ocular surface symptoms and improved PROSE tolerance and functionality.
Detailed description
This proof-of-concept study will investigate whether standard, on label, six-week treatment of Demodex Blepharitis (DB) with Xdemvy (lotilaner ophthalmic solution) 0.25% has a positive impact on ocular surface symptoms and PROSE device functionality and performance. The investigators hypothesize the use of Xdemvy in subjects utilizing PROSE treatment will be well tolerated and that the reduction in Demodex mite load (measured utilizing the surrogate, validated endpoint of lash collarettes 6,7) on the eyelid margin will result in reduced ocular surface symptoms and improved PROSE tolerance and functionality.
A total of up to SIX subjects with bilateral Demodex Blepharitis (> Grade 2, which is more than 10 collarettes of upper lash, in the worse eye) in a single clinic setting who currently wear scleral lenses on a daily basis for irregular corneas and/or ocular surface disease will be offered enrollment and will be included in the study The total duration of a subjects' participation in the study will be approximately 6 weeks.
Visit 1: Screening Visit [in person]:
- Completion of informed consent
- Review inclusion/exclusion criteria
- Collect age, sex, race, ethnicity, social history (drug, alcohol and smoking), medical history, past ocular history, past ocular surgical history (including ocular and refractive surgery), allergies, medications, habitual contact lens use.
- Symptom Questionnaires:
- Baseline questions b. Contact Lens Dry Eye Questionnaire-8 (CLDEQ-8) c. Visual Analog Scale (VAS) questions assessing: i. Tolerability for desired daily PROSE wear time ii. Fluctuating vision iii. Ocular Burning iv. Ocular Redness v. Ocular Itching e. Clinical Examinations:
- Best-Corrected Distance Visual Acuity (LogMAR)
- Slit Lamp Examination
- Collarette Scale (used in Saturn-1 and Saturn-2 clinical trials)
- Imaging:
- Standardized photographs of the upper and lower eyelids will be obtained. g. Diary
- Daily subject diaries will be dispensed to subjects. Subjects will collect - i. PROSE device wear times (hours of wear each day) ii. Document each PROSE device application and removal
- Document reason for removal iii. Document each dose instillation of Xdemvy iv. Document daily artificial tear use h. Dispense Xdemvy (lotilaner ophthalmic solution) 0.25% with instructions for use: one drop both eyes twice a day for 6 weeks. PROSE lenses should be removed prior to instillation of Xdemvy and may be reinserted 15 minutes following administration.8 Visit 2: Day 21 [3 day pre/post visit window] - Phone call
- Update: medical and ocular history, surgical history, social history, medications, allergies b. Review compliance with protocol c. Symptom Questionnaire:
- Contact Lens Dry Eye Questionnaire-8 (CLDEQ-8) d. Diary
- Reminder to complete daily diary Visit 3: Day 42 [7 day pre/post visit window] (In-person)
- Update: medical and ocular history, surgical history, social history, medications, allergies
- Review compliance with protocol
- Symptom Questionnaires:
- Contact Lens Dry Eye Questionnaire-8 (CLDEQ-8) b. Visual Analog Scale (VAS) questions assessing: i. Tolerability for desired daily PROSE wear time ii. Fluctuating vision iii. Ocular Burning iv. Ocular Redness v. Ocular Itching d. Clinical Examinations:
- Best-Corrected Distance Visual Acuity (LogMAR) b. Slit Lamp Examination c. Collarette Scale (used in Saturn-1 and Saturn-2 clinical trials) e. Imaging:
- Standardized photographs of the upper and lower eyelids will be obtained. f. Diary
- Collection g. Medication
- Collection
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients identified as having Demodex Blepharitis | Experimental | Drug: XdemvyThis study has one arm which is the treatment arm |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Written Informed Consent has been obtained prior to any study-related procedures taking place
- Subject is Male or Female, 18 years of age or older prior to the initial visit
- Is an established wearer of PROSE devices for > 6 months in both eyes
- Currently wears PROSE devices on a daily basis in both eyes
- No plans to alter the PROSE lens design in either eye during the study period
Key exclusion criteria (11 listed)
- Is currently participating in any other type of eye-related clinical research study
- Is pregnant or nursing as reported by the subject.
- Has a condition or is in a situation which, in the investigator's opinion, may put the subject at significant risk, may confound study outcomes, or may significantly interfere with the subject's participation in the study.
- Has had previous ocular surgery within the past 12 weeks or has planned ocular surgery during the study period.
- Has initiated any new blepharitis or ocular surface treatment within the last 12 weeks
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 |
|---|---|---|
| XdemvyAll subjects enrolled inthis study will be treated with xdemvy | Drug | Patients identified as having Demodex Blepharitis |
Primary outcome
1. The Contact Lens Dry Eye Questionnaire-8 (CLDEQ-8)
Time frame: Visit 1 - screening visit, Visit 2 - day 21, and Visit 3 - day 42
The Contact Lens Dry Eye Questionnaire-8 (CLDEQ-8) is a validated 8-item, self-report tool developed by Chalmers et al. in 2012 to assess the frequency and intensity of soft contact lens (SCL) discomfort and dryness. A total score of \(\ge 12\) indicates clinically significant discomfort and potential, which are strong predictors of patient dropout.
2. Visual analog scale (VAS) - Symptom and Lens Performance Scores
Time frame: Visit 1 - screening and Visit 3 - day 42
A Visual Analog Scale (VAS) is a subjective measurement tool, where individuals mark their symptom intensity (like pain, burning, or itching) to capture a continuous feeling not easily measured numerically. It's simple, widely used in healthcare for assessing symptom severity and treatment effectiveness, and recorded by measuring the distance from the "no" end, typically 0-100 mm. Subjects will complete VAS scales for Tolerability for desired daily PROSE wear time, Fluctuating vision, Ocular Burning, Ocular Redness, and Ocular Itching.
1 secondary outcome
Collarette grade
Time frame: Visit 1 - screening and Visit 3 - day 42
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 22 Oct 2026.
Related trials for Demodex Blepharitis
RecruitingPhase 2
Evaluation of the Safety and Efficacy of GLK-321 in Subjects With Demodex Blepharitis
Demodex Blepharitis
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.
Daniel Brocks, MD principal investigator
Boston Sight
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Xdemvy in people with Demodex Blepharitis, run by Boston Sight at 1 site 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 10 inclusion and 11 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 22 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 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?
1. The Contact Lens Dry Eye Questionnaire-8 (CLDEQ-8) (time frame: Visit 1 - screening visit, Visit 2 - day 21, and Visit 3 - day 42). The study lists 2 primary outcomes in all. 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 22 Oct 2026.