Efficacy of Zylet vs. Lotemax for the Treatment of Ocular Surface Inflammation/MGD/Blepharitis
Condition: Meibomian Gland Dysfunction; Posterior Blepharitis
MeSH terms: Meibomian Gland Dysfunction; Blepharitis; Inflammation
Intervention: Loteprednol/tobramycin; Loteprednol; B+L Advanced Eye Relief Lubricant Drop
Intervention description: Zylet (loteprednol/tobramycin) drops, 1 drop twice a day for 4 weeks.; Eye drops, 1 drop twice a day for 4 weeks; Bausch + Lomb (B+L) Advanced Eye Relief Lubricant Drop (Artificial Tears), 1 drop twice a day for 4 weeks.
Intervention MeSH terms: Loteprednol Etabonate; Tobramycin; Lubricant Eye Drops
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 60.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Meibomian gland dysfunction; Blepharitis; Dry Eye; Ocular Inflammation; MGD; Zylet; Lotemax; Artificial Tear

Summary:

      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.
    

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)