BlepharitisPhase 4NCT06795165
Study of the Safety and Efficacy of Moxidectin Tablets for the Reduction of Demodex Eyelash Infestation
A Phase 4 study testing Moxidectin 2 MG Oral Tablet in people with Blepharitis, run by Eye Research Foundation, Inc. at 1 site in United States.
Trial summary
A Single-Center, Investigator-Masked, Randomized, Placebo-Controlled, Investigator Initiated Study of the Safety and Efficacy of Moxidectin Tablets for the Reduction of Demodex Eyelash Infestation Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Blepharitis
- What is being tested?
- Moxidectin 2 MG Oral Tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Feb 2025to 15 Jun 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Active blepharitis with collarettes
Who cannot join
- Other clinically significant eye disease
Trial locations and contacts
1 site in 1 country.
United States1 site
Eye Research Foundation, Inc.
Newport Beach, California, 92663
About this study
Official title: A Single-center, Investigator-masked, Randomized, Placebo-controlled, Investigator-initiated Study of the Safety and Efficacy of Moxidectin Tablets for the Reduction of Demodex Eyelash Infestation.
A Single-Center, Investigator-Masked, Randomized, Placebo-Controlled, Investigator Initiated Study of the Safety and Efficacy of Moxidectin Tablets for the Reduction of Demodex Eyelash Infestation
- Conditions
- Blepharitis
- Being tested
- Moxidectin 2 MG Oral Tablet, Placebo
- Keywords
- blepharitis, demodex
- Medical subject headings
- Blepharitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Moxidectin 2 MG Oral TabletDrug
active medication
PlaceboDrug
placebo pills
| Study group | Role | What they receive |
|---|---|---|
| Active | Active comparator | Not described Receives: Drug: Moxidectin 2 MG Oral Tablet |
| Active and Placebo | Experimental | Not described Receives: Drug: Moxidectin 2 MG Oral Tablet; Drug: Placebo |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Collarette count
Collarette Count
Measured: 6 weels
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2025
- Study start2 Feb 2025
- Primary completion28 Apr 2025
- Study completion15 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eye Research Foundation, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06795165
- Sponsor's protocol ID
- MOX-001
- Status last verified
- Aug 2025
- First submitted
- 22 Jan 2025
- Last updated
- 12 Aug 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 12 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-center, Investigator-masked, Randomized, Placebo-controlled, Investigator-initiated Study of the Safety and Efficacy of Moxidectin Tablets for the Reduction of Demodex Eyelash Infestation.
- ClinicalTrials.gov ID
- NCT06795165
- Acronym / sponsor ID
- MOX-001
- Conditions
- Blepharitis
- Keywords
- blepharitis, demodex
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Eye Research Foundation, Inc.Industry (pharma, biotech, devices)
- Study start
- 2 Feb 2025 (actual)
- Primary completion
- 28 Apr 2025 (actual)
- Study completion
- 15 Jun 2025 (actual)
- First posted
- 27 Jan 2025 (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.
A Single-Center, Investigator-Masked, Randomized, Placebo-Controlled, Investigator Initiated Study of the Safety and Efficacy of Moxidectin Tablets for the Reduction of Demodex Eyelash Infestation
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Active | Active comparator | Drug: Moxidectin 2 MG Oral Tablet |
| Active and Placebo | Experimental | Drug: Moxidectin 2 MG Oral Tablet, Drug: Placebo |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Active blepharitis with collarettes
Key exclusion criteria (1 listed)
- Other clinically significant eye disease
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 |
|---|---|---|
| Moxidectin 2 MG Oral Tabletactive medication | Drug | Active, Active and Placebo |
| Placeboplacebo pills | Drug | Active and Placebo, Placebo |
Primary outcome
Collarette count
Time frame: 6 weels
Collarette Count
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 12 Aug 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.
The record lists no contact. Use the official record to reach the sponsor.
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 Moxidectin 2 MG Oral Tablet in people with Blepharitis, run by Eye Research Foundation, Inc. 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 1 inclusion and 1 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 12 Aug 2025. 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. 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?
Collarette count (time frame: 6 weels). 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 12 Aug 2025.