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

NCT03888378 | Completed Phase 2 FDA Drug

• 1 other identifier: HY02-002
• Study Type: interventional
• Target: 270
• Locations: 1 country
• Sites: 20

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.

Conditions

Meibomian Gland Dysfunction; MGD-Meibomian Gland Dysfunction

Keywords

Minocycline Topical; Tetracycline; Doxycycline; MGD; Meibomian Gland Disorder; Anti-Bacterial Agent; Anti-imflammatory Agent; Minocycline

Outcome Measures

Primary Outcomes (4)

• 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.

  12 Weeks

• 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.

  12 Weeks

• 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.

  12 Weeks

• 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.

  12 Weeks

Study Arms (3)

0.3% Topical Minocycline Ointment

ACTIVE COMPARATOR

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

Drug: 0.3% Topical Minocycline Ointment

1% Topical Minocycline Ointment

ACTIVE COMPARATOR

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

Drug: 1% Topical Minocycline Ointment

Topical Vehicle Ointment

PLACEBO COMPARATOR

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

Other: Topical Vehicle Ointment

Interventions

0.3% Topical Minocycline Ointment DRUG

0.3% Topical Minocycline ointment to treat inflamed Meibomian Gland Dysfunction

Also known as: HY02 Topical Ointment, 0.3%

0.3% Topical Minocycline Ointment

1% Topical Minocycline Ointment DRUG

1% Topical Minocycline ointment to treat inflamed Meibomian Gland Dysfunction

Also known as: HY02 Topical Ointment, 1%

1% Topical Minocycline Ointment

Topical Vehicle Ointment OTHER

Topical vehicle ointment to treat inflamed Meibomian Gland Dysfunction

Also known as: HY02 Topical Ointment, 0%

Topical Vehicle Ointment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)
• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Hovione Scientia Limited: lead

Study Sites (20)

Clinical site - 4

Azusa, California, 91702, United States

Location

Clinical site - 16

Huntington Beach, California, 92647, United States

Location

Clinical site - 12

Inglewood, California, 90301, United States

Location

Clinical site - 13

Mission Hills, California, 91345, United States

Location

Clinical site 10

Rancho Cordova, California, 95670, United States

Location

Clinical site - 15

Jacksonville, Florida, 32256, United States

Location

Clinical Site - 18

Largo, Florida, 33773, United States

Location

Clinical site - 6

Indianapolis, Indiana, 46260, United States

Location

Clinical site - 20

New Albany, Indiana, 47150, United States

Location

Clinical site - 19

Kansas City, Missouri, 64111, United States

Location

Clinical site - 3

St Louis, Missouri, 63131, United States

Location

Clinical site - 9

St Louis, Missouri, 63131, United States

Location

Clinical site - 7

Las Vegas, Nevada, 89145, United States

Location

Clinical site - 5

Asheville, North Carolina, 28803, United States

Location

Clinical site - 11

Mason, Ohio, 45040, United States

Location

Clinical site - 2

Memphis, Tennessee, 38119, United States

Location

Clinical site - 14

Cedar Park, Texas, 78613, United States

Location

Clinical Site - 1

El Paso, Texas, 79902, United States

Location

Clinical site - 8

League City, Texas, 77573, United States

Location

Clinical site - 17

Norfolk, Virginia, 23502, United States

Location

MeSH Terms

Conditions

Meibomian Gland Dysfunction; cyclopia sequence

Condition Hierarchy (Ancestors)

Eyelid Diseases; Eye Diseases

Study Officials

• George Magrath, MD

  Hovione Scientia Limited

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Care provider is a designated dosing coordinator who will be unblinded for this study. Both participant and investigator will be blinded.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 22, 2019
• First Posted: March 25, 2019
• Study Start: April 2, 2019
• Primary Completion: September 18, 2020
• Study Completion: February 1, 2021
• Last Updated: March 5, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (20)