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

Posterior blepharitis is a common chronic eyelid condition that is described as generalized
inflammation of the posterior lid margin and associated with inflammation of the ocular
surface and with symptoms of burning, irritation, and discomfort. Posterior blepharitis is
associated with various disorders of the meibomian glands, known collectively as meibomian
gland dysfunction (MGD). It is associated either with obstruction and inflammation of the
meibomian glands or, less commonly, atrophy of the meibomian glands.

Clinically, MGD often presents with inspissated meibomian glands, oily tear film, as well as
inflammation and vascularization of the meibomian gland orifices. Papillary hypertrophy of
the tarsal conjunctiva and corneal punctate epitheliopathy are often present, and there are
prominent associations with dermatoses, such as acne rosacea, seborrhoeic dermatitis, and
atopic dermatitis. Evidence from several sources suggests that MGD of sufficient extent and
degree is associated with a deficient tear lipid layer, an increase in tear evaporation, and
the occurrence of an evaporative dry eye. In fact MGD is considered to be the most common
cause of evaporative dry eye. Individuals with MGD often complain of significant discomfort,
including burning, itching, irritation, and photophobia. They may also have other associated
symptoms of dry eye and may be plagued by blurred vision, gradual contact lens intolerance.
Furthermore, these patients may become functionally handicapped by the negative impact of
dry eye on their crucial daily activities such as working, reading, using computer, and
driving.

Despite the high incidence of posterior blepharitis, there is currently no consistently
effective treatment for this condition and it still remains a therapeutic challenge.
Posterior blepharitis has traditionally been managed with eyelid hygiene, topical
antibiotics (erythromycin or bacitracin ointments), oral tetracyclines (tetracycline,
doxycycline, or minocycline) and corticosteroids which are often time consuming,
frustrating, and frequently ineffective or variably effective.

The purpose of this study is to compare the effectiveness of topical loteprednol
(corticosteroid) vs. the combination of loteprednol and tobramycin (corticosteroid and
antibiotic) against an artificial tear. It is critical to determine to what extent the
addition of an antibiotic to a topical steroid can enhance the therapeutic efficacy of the
treatment.

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 1+ in at least one eye

- OSDI score >30

- 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

- On systemic immunosuppressive regimen

- 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

- 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 last month

- 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)