A Phase 2 interventional study of AXR-270 Low Dose and AXR-270 High Dose in Posterior Blepharitis and Meibomian Gland Dysfunction, sponsored by AxeroVision, Inc.. Completed at 1 site in United States. Open to participants aged 18 Years to 100 Years. Per ClinicalTrials.gov, last updated 2023-07-21.
Sponsored by AxeroVision, Inc. · Phase 2, Interventional, and Treatment
Among 63 studies in Meibomian Gland Dysfunction with a site in United States — 7 open to participants now, 10 under way, none of them phase 3. Meibomian Gland Dysfunction · United States.
Among the 63 studies in Meibomian Gland Dysfunction with a site in United States, this one is the 10th largest by enrollment of the 61 interventional ones that give a count, is one of 5 that started in 2020, is one of 10 in phase 2, and was the 36th registered.
172 studies on the registry are indexed under Meibomian Gland Dysfunction; 23 are open to participants now.
Browse Meibomian Gland Dysfunction studies →7 of the 63 studies in Meibomian Gland Dysfunction with a site in United States are open now. Recruiting first, the newest first:
Cleveland Eye Clinic · Sites in United States
University of Alabama at Birmingham · Sites in United States
University of California, Berkeley · Sites in United States
University of Houston · Sites in United States
Illinois College of Optometry · Sites in United States
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 13 Meibomian Gland Dysfunction studies recruiting now, 10 (77%) set no upper age limit and 1 (8%) stop at 75 or younger; 1 take children under 18; 1 take healthy volunteers.
This study: 18 Years to 100 Years · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
63 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 2 · Phase 2 11 · Phase 4 7
First in 2008; this study’s year is marked. 5 started in 2020.
This study's enrollment of 129 is above the median of 50 across 138 interventional studies indexed under Meibomian Gland Dysfunction.
Median enrollment 44 across the 61 interventional studies, 33 across the 2 observational. Of the 44 that completed or were terminated, 29 (66%) have results posted.
This tab as a report to print or save as PDF → With an account.
29 of 63 have an industry lead sponsor. The 10 most frequent:
AxeroVision, Inc. is the lead sponsor of 2 studies on the registry; none are open to participants now.
AxeroVision, Inc. has 1 study filed under Meibomian Gland Dysfunction — fewer than ten, so there is no comparison to draw.
6 of the studies in Meibomian Gland Dysfunction with a site in United States that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07928986Cleveland Eye ClinicA Multi Center Evaluation of TearCare on Surgical Measurements Before Cataract Surgery | 2026-12 |
| NCT07229001Illinois College of OptometryTreating Meibomian Gland Disease in a Pediatric Population | 2026-12-30 |
| NCT07606625University of California, BerkeleyOcular Surface Health and Tear Film Stability With a Nasal Spray Dry Eye Treatment | 2026-12-31 |
| NCT07224529University of Alabama at BirminghamEfficacy of Vevye Ophthalmic Solution for the Treatment of Meibomian Gland Dysfunction | 2027-02-01 |
| NCT07579156University of Alabama at BirminghamTearCare in Young Adults | 2027-08-01 |
Among the 63 studies in Meibomian Gland Dysfunction with a site in United States, from their registry updates:
This tab as a report to print or save as PDF → With an account.
This study will evaluate the safety, tolerability and efficacy of AXR-270 Cream in treating posterior blepharitis associated with Meibomian Gland Disease (MGD)
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
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
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
Exclusion Criteria:
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
AXR-270 Low Dose administered once daily
Drug: AXR-270 Low Dose
AXR-270 High Dose administered once daily
Drug: AXR-270 High Dose
AXR-270 Vehicle administered once daily
Drug: AXR-270 Vehicle
AXR-270 Topical Eyelid Cream
AXR-270 Topical Eyelid Cream
AXR-270 Topical Eyelid Cream Vehicle
Adverse Events
Incidence of treatment emergent ocular and systemic adverse events (TEAE)
Time frame: 22 Days
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.
Time frame: 22 Days
| Milestone | AXR-270 Low Dose | AXR-270 High Dose | AXR-270 Vehicle |
|---|---|---|---|
| Started | 43 | 44 | 42 |
| Completed | 42 | 43 | 42 |
| Not completed | 1 | 1 | 0 |
| Milestone | AXR-270 Low Dose | AXR-270 High Dose | AXR-270 Vehicle |
|---|---|---|---|
| Started | 42 | 43 | 43 |
| Completed | 41 | 42 | 43 |
| Not completed | 1 | 1 | 0 |
Incidence of treatment emergent ocular and systemic adverse events (TEAE)
| adverse events | AXR-270 Low Dose | AXR-270 High Dose | AXR-270 Vehicle |
|---|---|---|---|
| Non-ocular TEAEs | 1 | 1 | 2 |
| Non-ocular Serious TEAEs | 0 | 0 | 0 |
| Ocular TEAEs | 0 | 0 | 4 |
| Ocular Serious TEAEs | 0 | 0 | 0 |
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.
| score on a scale | AXR-270 Low Dose | AXR-270 High Dose | AXR-270 Vehicle |
|---|---|---|---|
| Total Meibomian Gland Dysfunction Score | -0.9 ± 2.3 | -1.7 ± 2.1 | -2.1 ± 2.6 |
Collected over 22 days. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| AXR-270 Low Dose | 0/42 (0%) | 0/42 (0%) | 1/42 (2.4%) |
| AXR-270 High Dose | 0/43 (0%) | 0/43 (0%) | 1/43 (2.3%) |
| AXR-270 Vehicle | 0/43 (0%) | 0/43 (0%) | 4/43 (9.3%) |
| Event | AXR-270 Low Dose | AXR-270 High Dose | AXR-270 Vehicle |
|---|---|---|---|
| mild urinary tract infectionRenal and urinary disorders | 1/42 | 0/43 | 0/43 |
| CovidInfections and infestations | 0/42 | 0/43 | 1/43 |
| increased blood creatine phosphokinaseBlood and lymphatic system disorders | 0/42 | 0/43 | 1/43 |
| mild headacheNervous system disorders | 0/42 | 1/43 | 0/43 |
| mild eyelid pruritusEye disorders | 0/42 | 0/43 | 1/43 |
| mild eyelid erythema, edemaEye disorders | 0/42 | 0/43 | 1/43 |
Full analysis set
| Age, Continuous(years) | AXR-270 Low Dose | AXR-270 High Dose | AXR-270 Vehicle | Total |
|---|---|---|---|---|
| Mean | 68.0 ± 8.7 | 63.9 ± 17.4 | 64.3 ± 15.4 | 65.4 ± 14.3 |
| Sex: Female, Male(Participants) | AXR-270 Low Dose | AXR-270 High Dose | AXR-270 Vehicle | Total |
|---|---|---|---|---|
| Female | 34 | 28 | 30 | 92 |
| Male | 9 | 16 | 12 | 37 |
| Race/Ethnicity, Customized(Participants) | AXR-270 Low Dose | AXR-270 High Dose | AXR-270 Vehicle | Total |
|---|---|---|---|---|
| White | 40 | 38 | 37 | 115 |
| Black or African American | 2 | 2 | 3 | 7 |
| Asian | 0 | 3 | 2 | 5 |
| Native Hawaiian or Other Pacific Islander | 1 | 0 | 0 | 1 |
| American Indian or Alaska Native | 0 | 1 | 0 | 1 |
| Region of Enrollment(participants) | AXR-270 Low Dose | AXR-270 High Dose | AXR-270 Vehicle | Total |
|---|---|---|---|---|
| United States | 43 | 44 | 42 | 129 |
| Total Meibomian Gland Dysfunction Score(units on a scale) | AXR-270 Low Dose | AXR-270 High Dose | AXR-270 Vehicle | Total |
|---|---|---|---|---|
| Mean | 9.7 ± 1.6 | 9.5 ± 2.3 | 10.0 ± 2.3 | 9.7 ± 2.1 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from Jun 2020 to primary completion in Dec 2020, 5 months.
Results were first posted in Jul 2023, 2 years 7 months after primary completion.
How these figures are worked out, and which studies are left out of them.
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AxeroVision, Inc.