Efficacy of Zylet vs. Lotemax for the Treatment of Ocular Surface Inflammation/MGD/Blepharitis (ZvL)
Meibomian Gland Dysfunction, Posterior Blepharitis
About this trial
This is an interventional treatment trial for Meibomian Gland Dysfunction focused on measuring Meibomian gland dysfunction, Blepharitis, Dry Eye, Ocular Inflammation, MGD, Zylet, Lotemax, Artificial Tear
Eligibility Criteria
Inclusion Criteria:
- Male or female
- At least 18 years of age
- Has not worn contact lenses, except for bandage contact lens or rigid gas permeable lens, for at least 2 weeks prior to the study and agrees to not wear contact lenses during study
- Patient is in generally good & stable overall health
- Minimum corneal fluorescein staining of 4 in at least one eye
- OSDI score >22
- The patient must have a diagnosis of posterior blepharitis
- A negative urine pregnancy test result for women of childbearing potential
- Women of childbearing potential must agree to use adequate contraception (hormonal or barrier method of birth control) prior to study entry and for the duration of study participation.
- Normal lid position and closure
- Ability to understand and provide informed consent to participate in this study
- Willingness to follow study instructions and likely to complete all required visits
Exclusion Criteria:
- History of Stevens-Johnson syndrome or ocular pemphigoid
- History of eyelid surgery
- Intra-ocular surgery or ocular laser surgery within 3 months
- History of microbial keratitis, including herpes
- Active ocular allergies
- Corneal epithelial defect > 1mm2
- Any change in use of topical anti-inflammatories, such as steroids, Restasis, or NSAID within the past 2 weeks
- Any change in dosage of tetracycline compounds (tetracycline, doxycycline, and minocycline) within the past two weeks
- Use of isotretinoin (Accutane) within the past 6 months
- Pregnant or lactating women
- Signs of current infection, including fever and current treatment with antibiotics
- Active liver, renal, or hematologic disease
- The use of any other investigational drug
- Individuals with a known history of glaucoma, individuals with IOP >22 Hg in either eye and individuals with a known family history of glaucoma in primary (first degree) relatives (ie. mother, father, sibling or child)
Sites / Locations
- Massachusetts Eye & Ear Infirmary
Arms of the Study
Arm 1
Arm 2
Arm 3
Active Comparator
Active Comparator
Placebo Comparator
Zylet
Lotemax
B+L Advanced Eye Relief Lubricant Drop
Subject randomized to this arm will be treated with Zylet (Loteprednol/tobramycin), twice a day, for 4 weeks. Zylet is a combination of loteprednol and tobramycin. Loteprednol is in a class of drugs called corticosteroids. Loteprednol inhibits processes in the body that cause inflammation. Tobramycin is an antibiotic.
Subject randomized to this arm will be treated with Lotemax, twice a day, for 4 weeks. Lotemax is also known as loteprednol. Loteprednol is in a class of drugs called corticosteroids. Loteprednol inhibits processes in the body that cause inflammation.
Subject randomized to this arm will be treated with B+L Advanced Eye Relief Lubricant Eye Drops (Artificial Tears), twice a day, for 4 weeks.