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

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ClinicalTrials.gov Identifier: NCT03888378
Recruitment Status : Recruiting
First Posted : March 25, 2019
Last Update Posted : April 24, 2019
Sponsor:
Information provided by (Responsible Party):
Hovione Scientia Limited

Brief 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.

Condition or disease Intervention/treatment Phase
Meibomian Gland Dysfunction MGD-Meibomian Gland Dysfunction Drug: 0.3% Topical Minocycline Ointment Drug: 1% Topical Minocycline Ointment Other: Topical Vehicle Ointment Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 255 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Masking Description: Care provider is a designated dosing coordinator who will be unblinded for this study. Both participant and investigator will be blinded.
Primary Purpose: Treatment
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
Actual Study Start Date : April 2, 2019
Estimated Primary Completion Date : March 31, 2020
Estimated Study Completion Date : June 30, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: 0.3% Topical Minocycline Ointment
Topical administration of 0.3% Topical Minocycline Ointment. Regimen: Apply BID, morning and evening to eyelid margin
Drug: 0.3% Topical Minocycline Ointment
Compare the safety and efficacy of three treatment regimens: 0.3% topical minocycline ointment, 1% topical minocycline ointment and topical vehicle ointment
Other Name: HY02 Topical Ointment, 0.3%

Active Comparator: 1% Topical Minocycline Ointment
Topical administration of 1% Topical Minocycline Ointment. Regimen: Apply BID, morning and evening to eyelid margin
Drug: 1% Topical Minocycline Ointment
Compare the safety and efficacy of three treatment regimens: 0.3% topical minocycline ointment, 1% topical minocycline ointment and topical vehicle ointment
Other Name: HY02 Topical Ointment, 1%

Placebo Comparator: Topical Vehicle Ointment
Topical administration of Topical Vehicle Ointment. Regimen: Apply BID, morning and evening to eyelid margin
Other: Topical Vehicle Ointment
Compare the safety and efficacy of three treatment regimens: 0.3% topical minocycline ointment, 1% topical minocycline ointment and topical vehicle ointment
Other Name: HY02 Topical Ointment, 0%




Primary Outcome Measures :
  1. Change from baseline in Vascular Engorgement in 1% HY02 Ointment compared to vehicle at week 12 [ Time Frame: 12 Weeks ]
    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.

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

  3. Change from baseline in Vascular Engorgement in 0.3% HY02 Ointment compared to vehicle at week 12 [ Time Frame: 12 Weeks ]
    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.

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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • At Visit 1, individuals of any gender or any race will be eligible for study participation if they:

    1. Have provided written informed consent prior to any study procedures.
    2. Are 18 years of age or above.
    3. 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:

      1. Clinical sign severity score of at least 2 (moderate) on vascular engorgement at the eyelid margin and
      2. Clinical sign severity score of at least 2 (moderate) on plugging of the meibomian glands.
      3. Eye Discomfort Symptom score of ≥ 40 using VAS (0-100 point scale)
    4. 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:

      1. 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)
      2. Schirmer score of >7 mm without topical anesthesia
    5. Are willing and able to follow instructions and can be present for the required study visits for the duration of the study.
    6. 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.
    7. 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.

Exclusion Criteria:

In order for subjects to be eligible at Visit 1 they may not:

  1. Have presence of inflammation and/or active structural change in the iris or anterior chamber.
  2. Have lid structural abnormalities such as entropion or ectropion.
  3. 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.
  4. Subjects with ocular inflammatory conditions (e.g., conjunctivitis, keratitis, anterior blepharitis, etc.) not related to MGD.
  5. 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.
  6. Have suspected ocular fungal, viral or bacterial infection.
  7. Have had penetrating intraocular surgery in the past 90 days or require penetrating intraocular surgery during the study.
  8. Have had ocular surface surgery within 12 months of Visit 1 (e.g., LASIK, refractive, pterygium removal).
  9. 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.
  10. Have used topical ocular or oral antibiotics within 30 days of the study or expect to use during the study.
  11. Have used LipiFlow or hypochlorous acid spray within 30 days of the study or expect to use during the study.
  12. If using inhaled or intranasal corticosteroids, unable to maintain a stable dose for the duration of the study.
  13. Have ever used isotretinoin.
  14. If using Omega-3 supplements, dose must be stable for 3 months prior to Visit 1 and for the duration of the study.
  15. Have used topical cyclosporine within 30 days of the study or during the study.
  16. Have used topical lifitegrast within 30 days of the study or during the study.
  17. Have used systemic corticosteroids within 30 days prior to study entry or during study participation.
  18. Have used topical ocular corticosteroids or ocular non-steroidal anti-inflammatory drugs (NSAIDs) within 30 days prior to study entry and during study participation.
  19. Have used topical ocular antihistamine and/or mast cell stabilizers within 30 days prior to study entry or during study participation.
  20. 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.
  21. Are unwilling to discontinue use of contact lenses during the study.
  22. 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.
  23. Have a known hypersensitivity to minocycline, any other tetracycline antibiotic, or to any of the other ingredients in the investigational product.
  24. Are unable or unwilling to withhold the use of eyelid scrubs or use of mechanical therapy during the study.
  25. Have been diagnosed with glaucoma or are currently using any glaucoma medication.
  26. Have a history of herpetic keratitis.
  27. Have a concomitant ocular pathology other than condition under study assessed as potentially confounding by the investigator.
  28. Have a serious systemic disease or uncontrolled medical condition that in the judgment of the investigator could confound study assessments or limit compliance.
  29. Have been exposed to any investigational drug or investigational device within the preceding 30 days.
  30. 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.
  31. Have trigger factors including conjunctivochalasis, allergic conjunctivitis, contact lens intolerance, trichiasis, epithelial basement membrane dystrophy, infectious keratitis or conjunctivitis.
  32. 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03888378


Contacts
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Contact: George Magrath, MD (609) 918-2614 g_pdl@hovione.com

Locations
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United States, California
Clinical site - 4 Recruiting
Azusa, California, United States, 91702
Clinical site - 16 Recruiting
Huntington Beach, California, United States, 92647
Clinical site - 12 Recruiting
Inglewood, California, United States, 90301
Clinical site - 13 Recruiting
Mission Hills, California, United States, 91345
Clinical site 10 Recruiting
Rancho Cordova, California, United States, 95670
United States, Florida
Clinical site - 15 Recruiting
Jacksonville, Florida, United States, 32256
Clinical Site - 18 Recruiting
Largo, Florida, United States, 33773
United States, Indiana
Clinical site - 6 Recruiting
Indianapolis, Indiana, United States, 46260
Clinical site - 20 Recruiting
New Albany, Indiana, United States, 47150
United States, Missouri
Clinical site - 19 Recruiting
Kansas City, Missouri, United States, 64111
Clinical site - 3 Recruiting
Saint Louis, Missouri, United States, 63131
Clinical site - 9 Recruiting
Saint Louis, Missouri, United States, 63131
United States, Nevada
Clinical site - 7 Recruiting
Las Vegas, Nevada, United States, 89145
United States, North Carolina
Clinical site - 5 Recruiting
Asheville, North Carolina, United States, 28803
United States, Ohio
Clinical site - 11 Recruiting
Mason, Ohio, United States, 45040
United States, Tennessee
Clinical site - 2 Recruiting
Memphis, Tennessee, United States, 38119
United States, Texas
Clinical site - 14 Recruiting
Cedar Park, Texas, United States, 78613
Clinical Site - 1 Recruiting
El Paso, Texas, United States, 79902
Clinical site - 8 Recruiting
League City, Texas, United States, 77573
United States, Virginia
Clinical site - 17 Recruiting
Norfolk, Virginia, United States, 23502
Sponsors and Collaborators
Hovione Scientia Limited
Investigators
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Study Director: George Magrath, MD Hovione Scientia Limited

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Responsible Party: Hovione Scientia Limited
ClinicalTrials.gov Identifier: NCT03888378     History of Changes
Other Study ID Numbers: HY02-002
First Posted: March 25, 2019    Key Record Dates
Last Update Posted: April 24, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Hovione Scientia Limited:
Minocycline Topical
Tetracycline
Doxycycline
MGD
Meibomian Gland Disorder
Anti-Bacterial Agent
Anti-imflammatory Agent
Minocycline
Additional relevant MeSH terms:
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Pathologic Processes
Minocycline
Anti-Bacterial Agents
Anti-Infective Agents