A Phase 2 interventional study of AZR-MD-001 Active and AZR-MD-001 Vehicle in Meibomian Gland Dysfunction, sponsored by Azura Ophthalmics. Completed at 5 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-05-16.
Sponsored by Azura Ophthalmics · Phase 2, Interventional, and Treatment
AZ202001 is a multicenter study of AZR-MD-001 ointment and AZR-MD-001 vehicle in patients with Meibomian Gland Dysfunction (MGD)
AZ202001 is a multicenter, double-masked, vehicle-controlled, randomized, parallel group study evaluating the safety, efficacy and tolerability of AZR-MD-001 ointment and AZR-MD-001 vehicle in patients with Meibomian Gland Dysfunction (MGD)
168 studies on the registry are indexed under Meibomian Gland Dysfunction; 21 are open to participants now.
This study's enrollment of 31 is below the median of 50 across 139 interventional studies indexed under Meibomian Gland Dysfunction.
Browse Meibomian Gland Dysfunction studies →Azura Ophthalmics is the lead sponsor of 6 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
AZR-MD-001 Vehicle will be dosed up to twice weekly.
Drug: AZR-MD-001 Vehicle
AZR-MD-001 Active will be dosed up to twice weekly.
Drug: AZR-MD-001 Active
AZR-MD-001 is an active ophthalmic ointment
Also known as: AZR-MD-001 is an ophthalmic ointment
AZR-MD-001 is a vehicle ophthalmic ointment
Also known as: AZR-MD-001 Vehicle is an ophthalmic ointment
Meibum Gland Secretion Score (MGS)
Change from Baseline in MGS. The MGS can range from 0 (highly abnormal) to 45 (Normal). Meibomian gland assessment was completed using a handheld instrument, Meibomian Gland Evaluator, along the eyelid margin to ensure measurement consistency. A total of 15 glands will be evaluated along the lower eyelid margin, consisting of 5 glands located in each of the temporal, central and nasal regions, as shown below. For each of the 15 glands, expressed secretion characteristics will be graded on a 0-3 scale. For more detail see: Lane SS, DuBiner HB, Epstein RJ, et al. A new system, the LipiFlow, for the treatment of meibomian gland dysfunction (MGD). Cornea. 2012; 31(4): 396-404.
Time frame: Month 3
Total OSDI
Change from Baseline in Total Ocular Surface Disease Index (OSDI). The Total OSDI can range from 0 (normal) to 100 (abnormal). The OSDI questionnaire consists of 12 questions regarding ocular symptoms, environmental triggers, and vision-related functioning. The patient was asked to rate each symptom using a 5-point scale (0 to 4), where 0 = none of the time; 1 = some of the time; 2 = half of the time; 3 = most of the time; and 4 = all of the time. Seven questions related to visual functioning allow a response of "N/A" (not applicable). The total OSDI was calculated from the raw scores of each of the 12 questions based on the formula: (\[sum of scores for all questions answereda\] X 100)/(\[total number of questions answered\] X 4). Questions answered with N/A were excluded in the calculation of total OSDI.
Time frame: Day 14 to Month 3
| Milestone | AZR-MD-001 Vehicle | AZR-MD-001 Active |
|---|---|---|
| Started | 16 | 15 |
| Completed | 15 | 10 |
| Not completed | 1 | 5 |
Change from Baseline in MGS. The MGS can range from 0 (highly abnormal) to 45 (Normal). Meibomian gland assessment was completed using a handheld instrument, Meibomian Gland Evaluator, along the eyelid margin to ensure measurement consistency. A total of 15 glands will be evaluated along the lower eyelid margin, consisting of 5 glands located in each of the temporal, central and nasal regions, as shown below. For each of the 15 glands, expressed secretion characteristics will be graded on a 0-3 scale. For more detail see: Lane SS, DuBiner HB, Epstein RJ, et al. A new system, the LipiFlow, for the treatment of meibomian gland dysfunction (MGD). Cornea. 2012; 31(4): 396-404.
| score on a scale | AZR-MD-001 Vehicle | AZR-MD-001 Active |
|---|---|---|
| Meibum Gland Secretion Score (MGS) | 0.5 ± 1.83 | 7.4 ± 1.53 |
Change from Baseline in Total Ocular Surface Disease Index (OSDI). The Total OSDI can range from 0 (normal) to 100 (abnormal). The OSDI questionnaire consists of 12 questions regarding ocular symptoms, environmental triggers, and vision-related functioning. The patient was asked to rate each symptom using a 5-point scale (0 to 4), where 0 = none of the time; 1 = some of the time; 2 = half of the time; 3 = most of the time; and 4 = all of the time. Seven questions related to visual functioning allow a response of "N/A" (not applicable). The total OSDI was calculated from the raw scores of each of the 12 questions based on the formula: (\[sum of scores for all questions answereda\] X 100)/(\[total number of questions answered\] X 4). Questions answered with N/A were excluded in the calculation of total OSDI.
| score on a scale | AZR-MD-001 Vehicle | AZR-MD-001 Active |
|---|---|---|
| Total OSDI | -2.0 ± 3.49 | -8.1 ± 2.86 |
Collected over 3 months. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| AZR-MD-001 Vehicle | 0/16 (0%) | 0/16 (0%) | 2/16 (12.5%) |
| AZR-MD-001 Active | 1/15 (6.7%) | 1/15 (6.7%) | 8/15 (53.3%) |
| Event | AZR-MD-001 Vehicle | AZR-MD-001 Active |
|---|---|---|
| dysuriaRenal and urinary disorders | 0/16 | 1/15 |
| Event | AZR-MD-001 Vehicle | AZR-MD-001 Active |
|---|---|---|
| Eye painEye disorders | 1/16 | 4/15 |
| Eye irritationEye disorders | 1/16 | 2/15 |
| Eye pruritusEye disorders | 0/16 | 2/15 |
| Ocular discomfortEye disorders | 0/16 | 2/15 |
| Vision blurredEye disorders | 0/16 | 2/15 |
| Conjunctival hyperaemiaEye disorders | 0/16 | 1/15 |
| Dry eyeEye disorders | 1/16 | 1/15 |
| Foreign body sensationEye disorders | 0/16 | 1/15 |
| PhotophobiaEye disorders | 0/16 | 1/15 |
| Age, Continuous(years) | AZR-MD-001 Vehicle | AZR-MD-001 Active | Total |
|---|---|---|---|
| Mean | 58.6 ± 13.21 | 56 ± 20.74 | 57.3 ± 16.98 |
| Sex: Female, Male(Participants) | AZR-MD-001 Vehicle | AZR-MD-001 Active | Total |
|---|---|---|---|
| Female | 7 | 8 | 15 |
| Male | 9 | 6 | 15 |
| Race (NIH/OMB)(Participants) | AZR-MD-001 Vehicle | AZR-MD-001 Active | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 1 | 5 | 6 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 0 | 0 | 0 |
| White | 12 | 9 | 21 |
| More than one race | 3 | 0 | 3 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Region of Enrollment(participants) | AZR-MD-001 Vehicle | AZR-MD-001 Active | Total |
|---|---|---|---|
| Australia | 11 | 9 | 20 |
| New Zealand | 5 | 5 | 10 |
Documents are hosted by the registry — open the source record to download them.
Plan to share: No
This study is completed, as verified in Jan 2021. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Azura Ophthalmics