Posterior BlepharitisPhase 2NCT04469998
Evaluation of AXR-270 for the Treatment of Posterior Blepharitis Associated With Meibomian Gland Dysfunction
A Phase 2 study testing AXR-270 Low Dose and AXR-270 High Dose in people with Posterior Blepharitis and Meibomian Gland Dysfunction, run by AxeroVision, Inc. at 1 site in United States.
Trial summary
This study will evaluate the safety, tolerability and efficacy of AXR-270 Cream in treating posterior blepharitis associated with Meibomian Gland Disease (MGD) Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Posterior Blepharitis, Meibomian Gland Dysfunction
- What is being tested?
- AXR-270 Low Dose and AXR-270 High Dose
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 129 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Jun 2020to 31 Dec 2020
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female, 18 years or older
- Have a clinical diagnosis of moderate to severe MGD (total MGD score between 5 and 14 on a scale with a range between 0 and 15; and clinical severity score of eyelid margin vascularity of at least 2 (moderate))
- Have a score of ≥35 on Eye Discomfort using VAS
- Have a tFCS score between 3 and 14 on the NEI scale
- Have a Schirmer score of >7 mm
- Have a OSDI score >30
- If female, then subject should be non-pregnant and non-lactating
Who cannot join
- Subjects with iritis, uveitis in either eye
- Subjects with conjunctivitis, keratitis, severe anterior keratitis not related to MGD
- Subjects with lid abnormalities
- Subjects with ocular fungal, viral or bacterial infection
- Subjects unable or unwilling to withhold the use of eyelid scrubs
- Subjects with glaucoma and serious systemic disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase I/II, Randomized, Double-Masked, Vehicle-Controlled Study of the Safety, Tolerability, and Efficacy of AXR-270 Topical Eyelid Cream in Treating Posterior Blepharitis Associated With Meibomian Gland Dysfunction
This study will evaluate the safety, tolerability and efficacy of AXR-270 Cream in treating posterior blepharitis associated with Meibomian Gland Disease (MGD)
Read the detailed description
AXR201901 is a multicenter, randomized, double-masked, vehicle-controlled study of AXR-270 cream and AXR-270 vehicle in subjects with signs and symptoms of posterior blepharitis associated with meibomian gland dysfunction
- Conditions
- Posterior Blepharitis, Meibomian Gland Dysfunction
- Being tested
- AXR-270 Low Dose, AXR-270 High Dose, AXR-270 Vehicle
- Keywords
- Meibomian Gland Dysfunction, Posterior Blepharitis
- Medical subject headings
- Meibomian Gland Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AXR-270 Low DoseDrug
AXR-270 Topical Eyelid Cream
AXR-270 High DoseDrug
AXR-270 Topical Eyelid Cream
AXR-270 VehicleDrug
AXR-270 Topical Eyelid Cream Vehicle
| Study group | Role | What they receive |
|---|---|---|
| AXR-270 Low Dose | Experimental | AXR-270 Low Dose administered once daily Receives: Drug: AXR-270 Low Dose |
| AXR-270 High Dose | Experimental | AXR-270 High Dose administered once daily Receives: Drug: AXR-270 High Dose |
| AXR-270 Vehicle | Placebo comparator | AXR-270 Vehicle administered once daily Receives: Drug: AXR-270 Vehicle |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse Events
Incidence of treatment emergent ocular and systemic adverse events (TEAE)
Measured: 22 Days
Secondary outcomes (1)
Total Meibomian Gland Dysfunction Score
Change from Baseline in total MGD score (Study Eyelid):
The total MGD score is the sum of secretion of 5 central glands on the upper and lower eyelids. Each gland orifice was scored from 0-3. The total score range was from 0-15 per eyelid. The numbers reported are for the Study Eyelid of each subject (=eyelid with higher sum score of the Total MGD score and Vascularity of Eyelid Margin score at baseline). Greater negative scores indicate a better outcome.
Scores: 0 = clear/slightly yellow; 1 = opaque/yellow, whitish, particulate; 2 = paste; 3 = none/occluded.
Measured: 22 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2020
- Study start16 Jun 2020
- Primary completion1 Dec 2020
- Study completion31 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Posterior 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 129 participants (actual)
Sponsor and investigators
- Lead sponsor
- AxeroVision, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Houman D Hemmati, MD, PhD, Study director, AxeroVision, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04469998
- Sponsor's protocol ID
- AXR201901
- Status last verified
- Jul 2023
- First submitted
- 9 Jul 2020
- Last updated
- 21 Jul 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- 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 21 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I/II, Randomized, Double-Masked, Vehicle-Controlled Study of the Safety, Tolerability, and Efficacy of AXR-270 Topical Eyelid Cream in Treating Posterior Blepharitis Associated With Meibomian Gland Dysfunction
- ClinicalTrials.gov ID
- NCT04469998
- Acronym / sponsor ID
- AXR201901
- Conditions
- Posterior Blepharitis, Meibomian Gland Dysfunction
- Keywords
- Meibomian Gland Dysfunction, Posterior Blepharitis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 129 participants (actual)
- Lead sponsor
- AxeroVision, Inc.Industry (pharma, biotech, devices)
- Study start
- 16 Jun 2020 (actual)
- Primary completion
- 1 Dec 2020 (actual)
- Study completion
- 31 Dec 2020 (actual)
- First posted
- 14 Jul 2020 (actual)
- Results
- Posted 21 Jul 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will evaluate the safety, tolerability and efficacy of AXR-270 Cream in treating posterior blepharitis associated with Meibomian Gland Disease (MGD)
Detailed description
AXR201901 is a multicenter, randomized, double-masked, vehicle-controlled study of AXR-270 cream and AXR-270 vehicle in subjects with signs and symptoms of posterior blepharitis associated with meibomian gland dysfunction
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| AXR-270 Low Dose | Experimental | Drug: AXR-270 Low DoseAXR-270 Low Dose administered once daily |
| AXR-270 High Dose | Experimental | Drug: AXR-270 High DoseAXR-270 High Dose administered once daily |
| AXR-270 Vehicle | Placebo comparator | Drug: AXR-270 VehicleAXR-270 Vehicle administered once daily |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Male or female, 18 years or older
- Have a clinical diagnosis of moderate to severe MGD (total MGD score between 5 and 14 on a scale with a range between 0 and 15; and clinical severity score of eyelid margin vascularity of at least 2 (moderate))
- Have a score of ≥35 on Eye Discomfort using VAS
- Have a tFCS score between 3 and 14 on the NEI scale
- Have a Schirmer score of >7 mm
Key exclusion criteria (6 listed)
- Subjects with iritis, uveitis in either eye
- Subjects with conjunctivitis, keratitis, severe anterior keratitis not related to MGD
- Subjects with lid abnormalities
- Subjects with ocular fungal, viral or bacterial infection
- Subjects unable or unwilling to withhold the use of eyelid scrubs
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 |
|---|---|---|
| AXR-270 Low DoseAXR-270 Topical Eyelid Cream | Drug | AXR-270 Low Dose |
| AXR-270 High DoseAXR-270 Topical Eyelid Cream | Drug | AXR-270 High Dose |
| AXR-270 VehicleAXR-270 Topical Eyelid Cream Vehicle | Drug | AXR-270 Vehicle |
Primary outcome
Adverse Events
Time frame: 22 Days
Incidence of treatment emergent ocular and systemic adverse events (TEAE)
1 secondary outcome
Total Meibomian Gland Dysfunction Score
Time frame: 22 Days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
Houman D Hemmati, MD, PhD study director
AxeroVision, Inc.
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 AXR-270 Low Dose and AXR-270 High Dose in people with Posterior Blepharitis and Meibomian Gland Dysfunction, run by AxeroVision, 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 7 inclusion and 6 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 21 Jul 2023. 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?
Yes. Results are posted in the registry (first posted 21 Jul 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Adverse Events (time frame: 22 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 21 Jul 2023.