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Meibomian Gland DysfunctionPhase 2NCT03888378

Study to Evaluate the Safety and Efficacy of Minocycline Ointment in Subjects With Inflamed Meibomian Gland Dysfunction

A Phase 2 study testing 0.3% Topical Minocycline Ointment and 1% Topical Minocycline Ointment in people with Meibomian Gland Dysfunction and MGD-Meibomian Gland Dysfunction, run by Hovione Scientia Limited at 20 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

To evaluate the efficacy and safety of two strengths of HY02 Ointment versus Vehicle administered twice daily for twelve weeks in subjects with a diagnosis of Inflamed Meibomian Gland Dysfunction. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
0.3% Topical Minocycline Ointment and 1% Topical Minocycline Ointment
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
270 participants
Where
20 sitesUnited States
Study dates
2 Apr 2019to 1 Feb 2021
Phase
Phase 2
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

  • At Visit 1, individuals of any gender or any race will be eligible for study participation if they:
  • Have provided written informed consent prior to any study procedures.
  • Are 18 years of age or above.
  • Have a clinical diagnosis of moderate to severe MGD and who meet the following criteria, in a qualifying eyelid, at both Visit 1 (Screening) and Visit 2 (Randomization) examinations:
  • Clinical sign severity score of at least 2 (moderate) on vascular engorgement at the eyelid margin and
  • Clinical sign severity score of at least 2 (moderate) on plugging of the meibomian glands.
Show all 13Show fewer
  • Eye Discomfort Symptom score of ≥ 40 using VAS (0-100 point scale)
  • Meet the following criteria, in a qualifying eye (same eye that qualifies for Inclusion #3), at both the Visit 1 (Screening) and Visit 2 (Randomization) examinations:
  • Fluorescein corneal staining (FCS) total score ≥ 3 in the inferior, central, and nasal region combined score (NEI/Industry Workshop sections 1, 4 and 5 with 0-9 scale)
  • Schirmer score of >7 mm without topical anesthesia
  • Are willing and able to follow instructions and can be present for the required study visits for the duration of the study.
  • Have a BCVA, using corrective lenses if necessary, in both eyes of at least +0.7 as assessed by Early Treatment of Diabetic Retinopathy Study (ETDRS) or modified ETDRS.
  • If female, are non-pregnant, non-lactating and women of childbearing potential (WOCBP) must be using an acceptable method of birth control [e.g., an Intrauterine Contraceptive Device (IUCD) with a failure rate of <1%, hormonal contraceptives, or a barrier method] for the duration of the study. If a female subject is currently abstinent, they must agree to use one of the acceptable methods of birth control before they become sexually active.

Who cannot join

  • In order for subjects to be eligible at Visit 1 they may not:
  • Have presence of inflammation and/or active structural change in the iris or anterior chamber.
  • Have lid structural abnormalities such as entropion or ectropion.
  • In the eyelid that qualifies (based on Inclusion #3), have grade level 4 (Obstructed) on Character of Secretion of Meibomian Glands or grade level 4 (No glands are expressible) on the Expressibility of Meibomian Glands.
  • Subjects with ocular inflammatory conditions (e.g., conjunctivitis, keratitis, anterior blepharitis, etc.) not related to MGD.
  • Subjects who have FCS total score = 15 or a score = 3, in either eye, in the superior region NEI/Industry Workshop scale or subjects who have FCS with diffuse confluent staining, filaments or frank epithelial defects.
Show all 33Show fewer
  • Have suspected ocular fungal, viral or bacterial infection.
  • Have had penetrating intraocular surgery in the past 90 days or require penetrating intraocular surgery during the study.
  • Have had ocular surface surgery within 12 months of Visit 1 (e.g., LASIK, refractive, pterygium removal).
  • Subjects who within the past 90 days have had cauterization of the punctum or changes to the status (insertion or removal) of punctal plug(s) before the Screening Visit.
  • Have used topical ocular or oral antibiotics within 30 days of the study or expect to use during the study.
  • Have used LipiFlow or hypochlorous acid spray within 30 days of the study or expect to use during the study.
  • If using inhaled or intranasal corticosteroids, unable to maintain a stable dose for the duration of the study.
  • Have ever used isotretinoin.
  • If using Omega-3 supplements, dose must be stable for 3 months prior to Visit 1 and for the duration of the study.
  • Have used topical cyclosporine within 30 days of the study or during the study.
  • Have used topical lifitegrast within 30 days of the study or during the study.
  • Have used systemic corticosteroids within 30 days prior to study entry or during study participation.
  • Have used topical ocular corticosteroids or ocular non-steroidal anti-inflammatory drugs (NSAIDs) within 30 days prior to study entry and during study participation.
  • Have used topical ocular antihistamine and/or mast cell stabilizers within 30 days prior to study entry or during study participation.
  • Are unable or unwilling to discontinue using any preserved or unpreserved topical ocular medications (including artificial tears) upon Screening and for the duration of the study.
  • Are unwilling to discontinue use of contact lenses during the study.
  • Are unwilling to discontinue use of cosmetic makeup applied to the eyelids or eye lashes at the Screening Visit and during the study. If makeup was used, it should be removed at least 12 hours prior to Visit 1.
  • Have a known hypersensitivity to minocycline, any other tetracycline antibiotic, or to any of the other ingredients in the investigational product.
  • Are unable or unwilling to withhold the use of eyelid scrubs or use of mechanical therapy during the study.
  • Have been diagnosed with glaucoma or are currently using any glaucoma medication.
  • Have a history of herpetic keratitis.
  • Have a concomitant ocular pathology other than condition under study assessed as potentially confounding by the investigator.
  • Have a serious systemic disease or uncontrolled medical condition that in the judgment of the investigator could confound study assessments or limit compliance.
  • Have been exposed to any investigational drug or investigational device within the preceding 30 days.
  • Are an employee of the site that is directly involved in the management, administration, or support of this study or be an immediate family member of the same.
  • Have trigger factors including conjunctivochalasis, allergic conjunctivitis, contact lens intolerance, trichiasis, epithelial basement membrane dystrophy, infectious keratitis or conjunctivitis.
  • Have a documented history of ocular allergies, which, in the judgment of the investigator, are likely to have an acute increase in severity due to the expected timing of the exposure to the allergen to which the subject is sensitive. Subjects sensitive to seasonal allergens that are not expected to be present during the study are permitted.

Trial locations and contacts

20 sites in 1 country.

20 sites in 1 country

United States20 sites

  • Clinical site - 5

    Asheville, North Carolina, 28803

  • Clinical site - 4

    Azusa, California, 91702

  • Clinical site - 14

    Cedar Park, Texas, 78613

  • Clinical Site - 1

    El Paso, Texas, 79902

  • Clinical site - 16

    Huntington Beach, California, 92647

  • Clinical site - 6

    Indianapolis, Indiana, 46260

  • Clinical site - 12

    Inglewood, California, 90301

  • Clinical site - 15

    Jacksonville, Florida, 32256

  • Clinical site - 19

    Kansas City, Missouri, 64111

  • Clinical Site - 18

    Largo, Florida, 33773

  • Clinical site - 7

    Las Vegas, Nevada, 89145

  • Clinical site - 8

    League City, Texas, 77573

  • Clinical site - 11

    Mason, Ohio, 45040

  • Clinical site - 2

    Memphis, Tennessee, 38119

  • Clinical site - 13

    Mission Hills, California, 91345

  • Clinical site - 20

    New Albany, Indiana, 47150

  • Clinical site - 17

    Norfolk, Virginia, 23502

  • Clinical site 10

    Rancho Cordova, California, 95670

  • Clinical site - 3

    St Louis, Missouri, 63131

  • Clinical site - 9

    St Louis, Missouri, 63131

Other trials in United States

About this study

Official title: A Multi-Center, Double-Masked, Randomized, Vehicle-Controlled Study of the Efficacy and Safety of HY02 Ointment in Subjects With Inflamed Meibomian Gland Dysfunction

To evaluate the efficacy and safety of two strengths of HY02 Ointment versus Vehicle administered twice daily for twelve weeks in subjects with a diagnosis of Inflamed Meibomian Gland Dysfunction.

Being tested
0.3% Topical Minocycline Ointment, 1% Topical Minocycline Ointment, Topical Vehicle Ointment
Keywords
Minocycline Topical, Tetracycline, Doxycycline, MGD, Meibomian Gland Disorder, Anti-Bacterial Agent, Anti-imflammatory Agent, Minocycline
Medical subject headings
Meibomian Gland Dysfunction, cyclopia sequence

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 0.3% Topical Minocycline OintmentDrug

    Also called HY02 Topical Ointment, 0.3%

    0.3% Topical Minocycline ointment to treat inflamed Meibomian Gland Dysfunction

  • 1% Topical Minocycline OintmentDrug

    Also called HY02 Topical Ointment, 1%

    1% Topical Minocycline ointment to treat inflamed Meibomian Gland Dysfunction

  • Topical Vehicle OintmentOther

    Also called HY02 Topical Ointment, 0%

    Topical vehicle ointment to treat inflamed Meibomian Gland Dysfunction

Study groups in NCT03888378
Study groupRoleWhat they receive
0.3% Topical Minocycline OintmentActive comparatorTopical administration of 0.3% Topical Minocycline Ointment. Regimen: Apply BID (twice daily), morning and evening to eyelid margin
Receives: Drug: 0.3% Topical Minocycline Ointment
1% Topical Minocycline OintmentActive comparatorTopical administration of 1% Topical Minocycline Ointment. Regimen: Apply BID (twice daily), morning and evening to eyelid margin
Receives: Drug: 1% Topical Minocycline Ointment
Topical Vehicle OintmentPlacebo comparatorTopical administration of Topical Vehicle Ointment. Regimen: Apply BID (twice daily), morning and evening to eyelid margin
Receives: Other: Topical Vehicle Ointment

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change from baseline in Vascular Engorgement in 1% HY02 Ointment compared to vehicle at week 12

    Changes in Vascular Engorgement at the study eyelid margin are graded on a 5-point scale (0-4) with 0 representing minimal vascular engorgement and 4 representing maximal vascular engorgement. A lower score represents a better outcome for the subject.

    Measured: 12 Weeks

  2. Change from baseline in Eye Discomfort Visual Analogue Score (VAS) at week 12 in the 1% HY02 Ointment arm compared to vehicle

    Eye discomfort will be evaluated on a subject reported visual analog scale. The scores range from 0 (no discomfort) to 100 (maximal discomfort). Lower score indicate a better outcome for the subject.

    Measured: 12 Weeks

  3. Change from baseline in Vascular Engorgement in 0.3% HY02 Ointment compared to vehicle at week 12

    Changes in Vascular Engorgement at the study eyelid margin are graded on a 5-point scale (0-4) with 0 representing minimal vascular engorgement and 4 representing maximal vascular engorgement. A lower score represents a better outcome for the subject.

    Measured: 12 Weeks

  4. Change from baseline in Eye Discomfort Visual Analogue Score (VAS) at week 12 in the 0.3% HY02 Ointment arm compared to vehicle

    Eye discomfort will be evaluated on a subject reported visual analog scale. The scores range from 0 (no discomfort) to 100 (maximal discomfort). Lower score indicate a better outcome for the subject.

    Measured: 12 Weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Mar 2019
  2. Study start2 Apr 2019
  3. Primary completion18 Sep 2020
  4. Study completion1 Feb 2021

Resources

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
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
270 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03888378
Sponsor's protocol ID
HY02-002
Status last verified
Mar 2021
First submitted
22 Mar 2019
Last updated
5 Mar 2021
Results posted
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing 0.3% Topical Minocycline Ointment and 1% Topical Minocycline Ointment in people with Meibomian Gland Dysfunction and MGD-Meibomian Gland Dysfunction, run by Hovione Scientia Limited at 20 sites 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 13 inclusion and 33 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 5 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 20 sites 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?

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?

Change from baseline in Vascular Engorgement in 1% HY02 Ointment compared to vehicle at week 12 (time frame: 12 Weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03888378.

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 5 Mar 2021.

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