Efficacy of Zylet vs. Lotemax for the Treatment of Ocular Surface Inflammation/MGD/Blepharitis

Completed · Phase 4

Conditions studied: Meibomian Gland Dysfunction, Posterior Blepharitis

In brief

This is a Phase IV, single site, randomized, double masked, parallel control clinical trial of 60 subjects to investigate the variance of efficacy between Lotemax® and Zylet® for treatment of ocular surface inflammation due to meibomian gland dysfunction (MGD). Efficacy will be measured by in-vivo confocal microscopy, corneal fluorescein staining, grading of meibomian gland dysfunction and validated ocular symptom assessment questionnaire.

Key facts

Study ID

NCT01456780

Run by

Massachusetts Eye and Ear Infirmary

People needed

60

Starts

2011-08-01

Expected to finish

2017-06-01

Last updated by the study team

2017-08-01

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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)

Where it is running

• Massachusetts Eye & Ear Infirmary — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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