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Trial record 1 of 2 for:    hovione
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Study to Evaluate the Safety and Efficacy of Minocycline Ointment in Subjects With Inflamed Meibomian Gland Dysfunction

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03888378
Recruitment Status : Active, not recruiting
First Posted : March 25, 2019
Last Update Posted : April 15, 2020
Sponsor:
Information provided by (Responsible Party):
Hovione Scientia Limited

Tracking Information
First Submitted Date  ICMJE March 22, 2019
First Posted Date  ICMJE March 25, 2019
Last Update Posted Date April 15, 2020
Actual Study Start Date  ICMJE April 2, 2019
Estimated Primary Completion Date September 18, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 25, 2019)
  • 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.
  • 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.
  • 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.
  • 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.
Original Primary Outcome Measures  ICMJE
 (submitted: March 22, 2019)
  • Change in Vascular Engorgement in 1% HY02 Ointment [ Time Frame: 12 Weeks ]
    Changes in Vascular Engorgement at the study eyelid margin as graded by the investigator at Week 12 (Visit 6) from Randomization/Baseline (Visit 2) in 1% HY02 Ointment compared to Vehicle
  • Change in Visual Analogue Score (VAS) [ Time Frame: 12 Weeks ]
    Change in Eye Discomfort Visual Analogue Score (VAS) at Week 12 (Visit 6) from Randomization/Baseline (Visit 2) in 1% HY02 Ointment compared to Vehicle
  • Change in Vascular Engorgement in 0.3% HY02 Ointment [ Time Frame: 12 Weeks ]
    Changes in Vascular Engorgement at the study eyelid margin as graded by the investigator at Week 12 (Visit 6) from Randomization/Baseline (Visit 2) in 0.3% HY02 Ointment compared to Vehicle
  • Change in Eye Discomfort VAS [ Time Frame: 12 Weeks ]
    Change in Eye Discomfort VAS at Week 12 (Visit 6) from Randomization/Baseline (Visit 2) in 0.3% HY02 Ointment compared to Vehicle
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study to Evaluate the Safety and Efficacy of Minocycline Ointment in Subjects With Inflamed Meibomian Gland Dysfunction
Official Title  ICMJE A Multi-Center, Double-Masked, Randomized, Vehicle-Controlled Study of the Efficacy and Safety of HY02 Ointment in Subjects With Inflamed Meibomian Gland Dysfunction
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE 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
Condition  ICMJE
  • Meibomian Gland Dysfunction
  • MGD-Meibomian Gland Dysfunction
Intervention  ICMJE
  • 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%
  • 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%
  • 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%
Study Arms  ICMJE
  • Active Comparator: 0.3% Topical Minocycline Ointment
    Topical administration of 0.3% Topical Minocycline Ointment. Regimen: Apply BID, morning and evening to eyelid margin
    Intervention: Drug: 0.3% Topical Minocycline Ointment
  • Active Comparator: 1% Topical Minocycline Ointment
    Topical administration of 1% Topical Minocycline Ointment. Regimen: Apply BID, morning and evening to eyelid margin
    Intervention: Drug: 1% Topical Minocycline Ointment
  • Placebo Comparator: Topical Vehicle Ointment
    Topical administration of Topical Vehicle Ointment. Regimen: Apply BID, morning and evening to eyelid margin
    Intervention: Other: Topical Vehicle Ointment
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: April 14, 2020)
270
Original Estimated Enrollment  ICMJE
 (submitted: March 22, 2019)
255
Estimated Study Completion Date  ICMJE January 29, 2021
Estimated Primary Completion Date September 18, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03888378
Other Study ID Numbers  ICMJE HY02-002
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Hovione Scientia Limited
Study Sponsor  ICMJE Hovione Scientia Limited
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: George Magrath, MD Hovione Scientia Limited
PRS Account Hovione Scientia Limited
Verification Date April 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP