Demodex BlepharitisPhase 2NCT07400965
Evaluation of the Safety and Efficacy of GLK-321 in Subjects With Demodex Blepharitis
A Phase 2 study testing GLK-321 low dose BID, GLK-321 mid dose BID and GLK-321 high dose BID in people with Demodex Blepharitis, run by Glaukos Corporation at 1 site in United States.
Trial summary
This is a randomized, double-masked, placebo-controlled, dose-ranging, parallel-group, multi-center study designed to evaluate the safety and efficacy of GLK-321 in patients with Demodex blepharitis. 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?
- GLK-321 low dose BID, GLK-321 mid dose BID and GLK-321 high dose BID
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 250 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Dec 2025to Nov 2026
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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
- Signs of Demodex blepharitis in at least one eye
- Best Spectacle Corrected Visual Acuity (BSCVA) of 20/80 Snellen or better in each eye
Who cannot join
- Presence of eczema or dermatitis in the ocular region of either eye
- Use of lid hygiene products within 14 days of Screening
- Active ocular infection or inflammation, other than blepharitis, in either eye at Screening
- Women who are pregnant, planning a pregnancy, or nursing
- Have used an investigational drug or device within 30 days prior to Screening or concurrently enrolled in another investigational drug or device trial
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Glaukos Clinical Study Site
Newport Beach, California, 92663
Study Manager, 949-739-8749, ClinicalResearch@Glaukos.com
About this study
Official title: Multicenter, Randomized, Double-Masked, Placebo-Controlled, Parallel Group Phase 2 Trial Evaluating the Safety and Efficacy of GLK-321 in Subjects With Demodex Blepharitis
This is a randomized, double-masked, placebo-controlled, dose-ranging, parallel-group, multi-center study designed to evaluate the safety and efficacy of GLK-321 in patients with Demodex blepharitis.
- Conditions
- Demodex Blepharitis
- Being tested
- GLK-321 low dose BID, GLK-321 mid dose BID, GLK-321 high dose BID, GLK-321 high dose QD, Placebo BID
- Keywords
- demodex blepharitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GLK-321 low dose BIDDrug
Twice daily administration of low dose GLK-321 to both eyes
GLK-321 mid dose BIDDrug
Twice daily administration of mid dose GLK-321 to both eyes
GLK-321 high dose BIDDrug
Twice daily administration of high dose GLK-321 to both eyes
GLK-321 high dose QDDrug
Once daily administration of high dose GLK-321 to both eyes
Placebo BIDDrug
Twice daily administration of placebo to both eyes
| Study group | Role | What they receive |
|---|---|---|
| GLK-321 low dose BID | Experimental | Low dose of GLK-321 administered twice daily (BID) to both eyes Receives: Drug: GLK-321 low dose BID |
| GLK-321 mid dose BID | Experimental | Mid dose of GLK-321 administered twice daily (BID) to both eyes Receives: Drug: GLK-321 mid dose BID |
| GLK-321 high dose BID | Experimental | High dose of GLK-321 administered twice daily (BID) to both eyes Receives: Drug: GLK-321 high dose BID |
| GLK-321 high dose QD | Experimental | High dose of GLK-321 administered once daily (QD) to both eyes Receives: Drug: GLK-321 high dose QD |
| Placebo BID | Placebo comparator | Placebo administered twice daily (BID) to both eyes Receives: Drug: Placebo BID |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of study eyes with elimination of collarettes
Percentage of study eyes that had eyelash collarettes due to Demodex blepharitis at the onset of treatment who demonstrate absence of collarettes after 6 weeks of treatment
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2026
- Study start5 Dec 2025
- Primary completionSep 2026 (estimated)
- Study completionNov 2026 (estimated)
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.
- More trials run by Glaukos CorporationThe sponsor's other registered studies.
- 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Glaukos Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Study Director, MD, Study director, Glaukos Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07400965
- Sponsor's protocol ID
- GLK-321-01
- Status last verified
- Feb 2026
- First submitted
- 3 Feb 2026
- Last updated
- 27 Feb 2026
- 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 27 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter, Randomized, Double-Masked, Placebo-Controlled, Parallel Group Phase 2 Trial Evaluating the Safety and Efficacy of GLK-321 in Subjects With Demodex Blepharitis
- ClinicalTrials.gov ID
- NCT07400965
- Acronym / sponsor ID
- GLK-321-01
- Conditions
- Demodex Blepharitis
- Keywords
- demodex blepharitis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Glaukos CorporationIndustry (pharma, biotech, devices)
- Study start
- 5 Dec 2025 (actual)
- Primary completion
- Sep 2026 (estimated)
- Study completion
- Nov 2026 (estimated)
- First posted
- 10 Feb 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.
This is a randomized, double-masked, placebo-controlled, dose-ranging, parallel-group, multi-center study designed to evaluate the safety and efficacy of GLK-321 in patients with Demodex blepharitis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| GLK-321 low dose BID | Experimental | Drug: GLK-321 low dose BIDLow dose of GLK-321 administered twice daily (BID) to both eyes |
| GLK-321 mid dose BID | Experimental | Drug: GLK-321 mid dose BIDMid dose of GLK-321 administered twice daily (BID) to both eyes |
| GLK-321 high dose BID | Experimental | Drug: GLK-321 high dose BIDHigh dose of GLK-321 administered twice daily (BID) to both eyes |
| GLK-321 high dose QD | Experimental | Drug: GLK-321 high dose QDHigh dose of GLK-321 administered once daily (QD) to both eyes |
| Placebo BID | Placebo comparator | Drug: Placebo BIDPlacebo administered twice daily (BID) to both eyes |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Signs of Demodex blepharitis in at least one eye
- Best Spectacle Corrected Visual Acuity (BSCVA) of 20/80 Snellen or better in each eye
Key exclusion criteria (5 listed)
- Presence of eczema or dermatitis in the ocular region of either eye
- Use of lid hygiene products within 14 days of Screening
- Active ocular infection or inflammation, other than blepharitis, in either eye at Screening
- Women who are pregnant, planning a pregnancy, or nursing
- Have used an investigational drug or device within 30 days prior to Screening or concurrently enrolled in another investigational drug or device trial
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 |
|---|---|---|
| GLK-321 low dose BIDTwice daily administration of low dose GLK-321 to both eyes | Drug | GLK-321 low dose BID |
| GLK-321 mid dose BIDTwice daily administration of mid dose GLK-321 to both eyes | Drug | GLK-321 mid dose BID |
| GLK-321 high dose BIDTwice daily administration of high dose GLK-321 to both eyes | Drug | GLK-321 high dose BID |
| GLK-321 high dose QDOnce daily administration of high dose GLK-321 to both eyes | Drug | GLK-321 high dose QD |
| Placebo BIDTwice daily administration of placebo to both eyes | Drug | Placebo BID |
Primary outcome
Percentage of study eyes with elimination of collarettes
Time frame: 6 weeks
Percentage of study eyes that had eyelash collarettes due to Demodex blepharitis at the onset of treatment who demonstrate absence of collarettes after 6 weeks of treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2026.
- Individual participant dataSharing planned: No
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.
Study Director, MD study director
Glaukos Corporation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing GLK-321 low dose BID, GLK-321 mid dose BID and GLK-321 high dose BID in people with Demodex Blepharitis, run by Glaukos Corporation 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 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: looking for participants now, as of the sponsor's last update on 27 Feb 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. 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 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Study Manager (949-739-8749, ClinicalResearch@Glaukos.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of study eyes with elimination of collarettes (time frame: 6 weeks). 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 27 Feb 2026.