Status:
COMPLETED
Efficacy of Zylet vs. Lotemax for the Treatment of Ocular Surface Inflammation/MGD/Blepharitis
Lead Sponsor:
Massachusetts Eye and Ear Infirmary
Collaborating Sponsors:
Bausch & Lomb Incorporated
Conditions:
Meibomian Gland Dysfunction
Posterior Blepharitis
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief 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 s...
Detailed Description
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 sym...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
August 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2017
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT01456780
Start Date
August 1 2011
End Date
June 1 2017
Last Update
August 1 2017
Active Locations (1)
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1
Massachusetts Eye & Ear Infirmary
Boston, Massachusetts, United States, 02114