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

Primary Purpose

Meibomian Gland Dysfunction, MGD-Meibomian Gland Dysfunction

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
0.3% Topical Minocycline Ointment
1% Topical Minocycline Ointment
Topical Vehicle Ointment
Sponsored by
Hovione Scientia Limited
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Meibomian Gland Dysfunction focused on measuring Minocycline Topical, Tetracycline, Doxycycline, MGD, Meibomian Gland Disorder, Anti-Bacterial Agent, Anti-imflammatory Agent, Minocycline

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Clinical site - 4
  • Clinical site - 16
  • Clinical site - 12
  • Clinical site - 13
  • Clinical site 10
  • Clinical site - 15
  • Clinical Site - 18
  • Clinical site - 6
  • Clinical site - 20
  • Clinical site - 19
  • Clinical site - 3
  • Clinical site - 9
  • Clinical site - 7
  • Clinical site - 5
  • Clinical site - 11
  • Clinical site - 2
  • Clinical site - 14
  • Clinical Site - 1
  • Clinical site - 8
  • Clinical site - 17

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Placebo Comparator

Arm Label

0.3% Topical Minocycline Ointment

1% Topical Minocycline Ointment

Topical Vehicle Ointment

Arm Description

Topical administration of 0.3% Topical Minocycline Ointment. Regimen: Apply BID (twice daily), morning and evening to eyelid margin

Topical administration of 1% Topical Minocycline Ointment. Regimen: Apply BID (twice daily), morning and evening to eyelid margin

Topical administration of Topical Vehicle Ointment. Regimen: Apply BID (twice daily), morning and evening to eyelid margin

Outcomes

Primary Outcome Measures

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.
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.
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.
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.

Secondary Outcome Measures

Full Information

First Posted
March 22, 2019
Last Updated
March 1, 2021
Sponsor
Hovione Scientia Limited
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1. Study Identification

Unique Protocol Identification Number
NCT03888378
Brief Title
Study to Evaluate the Safety and Efficacy of Minocycline Ointment in Subjects With Inflamed Meibomian Gland Dysfunction
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2021
Overall Recruitment Status
Completed
Study Start Date
April 2, 2019 (Actual)
Primary Completion Date
September 18, 2020 (Actual)
Study Completion Date
February 1, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hovione Scientia Limited

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Meibomian Gland Dysfunction, MGD-Meibomian Gland Dysfunction
Keywords
Minocycline Topical, Tetracycline, Doxycycline, MGD, Meibomian Gland Disorder, Anti-Bacterial Agent, Anti-imflammatory Agent, Minocycline

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Masking Description
Care provider is a designated dosing coordinator who will be unblinded for this study. Both participant and investigator will be blinded.
Allocation
Randomized
Enrollment
270 (Actual)

8. Arms, Groups, and Interventions

Arm Title
0.3% Topical Minocycline Ointment
Arm Type
Active Comparator
Arm Description
Topical administration of 0.3% Topical Minocycline Ointment. Regimen: Apply BID (twice daily), morning and evening to eyelid margin
Arm Title
1% Topical Minocycline Ointment
Arm Type
Active Comparator
Arm Description
Topical administration of 1% Topical Minocycline Ointment. Regimen: Apply BID (twice daily), morning and evening to eyelid margin
Arm Title
Topical Vehicle Ointment
Arm Type
Placebo Comparator
Arm Description
Topical administration of Topical Vehicle Ointment. Regimen: Apply BID (twice daily), morning and evening to eyelid margin
Intervention Type
Drug
Intervention Name(s)
0.3% Topical Minocycline Ointment
Other Intervention Name(s)
HY02 Topical Ointment, 0.3%
Intervention Description
0.3% Topical Minocycline ointment to treat inflamed Meibomian Gland Dysfunction
Intervention Type
Drug
Intervention Name(s)
1% Topical Minocycline Ointment
Other Intervention Name(s)
HY02 Topical Ointment, 1%
Intervention Description
1% Topical Minocycline ointment to treat inflamed Meibomian Gland Dysfunction
Intervention Type
Other
Intervention Name(s)
Topical Vehicle Ointment
Other Intervention Name(s)
HY02 Topical Ointment, 0%
Intervention Description
Topical vehicle ointment to treat inflamed Meibomian Gland Dysfunction
Primary Outcome Measure Information:
Title
Change from baseline in Vascular Engorgement in 1% HY02 Ointment compared to vehicle at week 12
Description
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.
Time Frame
12 Weeks
Title
Change from baseline in Eye Discomfort Visual Analogue Score (VAS) at week 12 in the 1% HY02 Ointment arm compared to vehicle
Description
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.
Time Frame
12 Weeks
Title
Change from baseline in Vascular Engorgement in 0.3% HY02 Ointment compared to vehicle at week 12
Description
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.
Time Frame
12 Weeks
Title
Change from baseline in Eye Discomfort Visual Analogue Score (VAS) at week 12 in the 0.3% HY02 Ointment arm compared to vehicle
Description
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.
Time Frame
12 Weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. 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. Exclusion Criteria: 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. 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
George Magrath, MD
Organizational Affiliation
Hovione Scientia Limited
Official's Role
Study Director
Facility Information:
Facility Name
Clinical site - 4
City
Azusa
State/Province
California
ZIP/Postal Code
91702
Country
United States
Facility Name
Clinical site - 16
City
Huntington Beach
State/Province
California
ZIP/Postal Code
92647
Country
United States
Facility Name
Clinical site - 12
City
Inglewood
State/Province
California
ZIP/Postal Code
90301
Country
United States
Facility Name
Clinical site - 13
City
Mission Hills
State/Province
California
ZIP/Postal Code
91345
Country
United States
Facility Name
Clinical site 10
City
Rancho Cordova
State/Province
California
ZIP/Postal Code
95670
Country
United States
Facility Name
Clinical site - 15
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32256
Country
United States
Facility Name
Clinical Site - 18
City
Largo
State/Province
Florida
ZIP/Postal Code
33773
Country
United States
Facility Name
Clinical site - 6
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46260
Country
United States
Facility Name
Clinical site - 20
City
New Albany
State/Province
Indiana
ZIP/Postal Code
47150
Country
United States
Facility Name
Clinical site - 19
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64111
Country
United States
Facility Name
Clinical site - 3
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63131
Country
United States
Facility Name
Clinical site - 9
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63131
Country
United States
Facility Name
Clinical site - 7
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89145
Country
United States
Facility Name
Clinical site - 5
City
Asheville
State/Province
North Carolina
ZIP/Postal Code
28803
Country
United States
Facility Name
Clinical site - 11
City
Mason
State/Province
Ohio
ZIP/Postal Code
45040
Country
United States
Facility Name
Clinical site - 2
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38119
Country
United States
Facility Name
Clinical site - 14
City
Cedar Park
State/Province
Texas
ZIP/Postal Code
78613
Country
United States
Facility Name
Clinical Site - 1
City
El Paso
State/Province
Texas
ZIP/Postal Code
79902
Country
United States
Facility Name
Clinical site - 8
City
League City
State/Province
Texas
ZIP/Postal Code
77573
Country
United States
Facility Name
Clinical site - 17
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23502
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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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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