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

• Status: Completed
• Trial end date: 2017-06-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Massachusetts Eye and Ear Infirmary
• Collaborator: Bausch & Lomb Incorporated
• Treatments: Loteprednol Etabonate; Lubricant Eye Drops; Ophthalmic Solutions; Tetrahydrozoline; Tobramycin

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)