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

NCT ID: NCT01456780

Last Updated: 2017-08-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-08-31
• Study Completion Date: 2017-06-30

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 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.

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 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.

Conditions

Meibomian Gland Dysfunction; Posterior Blepharitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Zylet

Subject randomized to this arm will be treated with Zylet (Loteprednol/tobramycin), twice a day, for 4 weeks. Zylet is a combination of loteprednol and tobramycin. Loteprednol is in a class of drugs called corticosteroids. Loteprednol inhibits processes in the body that cause inflammation. Tobramycin is an antibiotic.

Group Type: ACTIVE_COMPARATOR

Loteprednol/tobramycin

Intervention Type: DRUG

Zylet (loteprednol/tobramycin) drops, 1 drop twice a day for 4 weeks.

Lotemax

Subject randomized to this arm will be treated with Lotemax, twice a day, for 4 weeks. Lotemax is also known as loteprednol. Loteprednol is in a class of drugs called corticosteroids. Loteprednol inhibits processes in the body that cause inflammation.

Group Type: ACTIVE_COMPARATOR

Loteprednol

Intervention Type: DRUG

Eye drops, 1 drop twice a day for 4 weeks

B+L Advanced Eye Relief Lubricant Drop

Subject randomized to this arm will be treated with B+L Advanced Eye Relief Lubricant Eye Drops (Artificial Tears), twice a day, for 4 weeks.

Group Type: PLACEBO_COMPARATOR

B+L Advanced Eye Relief Lubricant Drop

Intervention Type: DRUG

Bausch + Lomb (B+L) Advanced Eye Relief Lubricant Drop (Artificial Tears), 1 drop twice a day for 4 weeks.

Interventions

Loteprednol/tobramycin

Zylet (loteprednol/tobramycin) drops, 1 drop twice a day for 4 weeks.

Intervention Type: DRUG

Loteprednol

Eye drops, 1 drop twice a day for 4 weeks

Intervention Type: DRUG

B+L Advanced Eye Relief Lubricant Drop

Bausch + Lomb (B+L) Advanced Eye Relief Lubricant Drop (Artificial Tears), 1 drop twice a day for 4 weeks.

Intervention Type: DRUG

Other Intervention Names

Zylet; Lotemax; artificial tears

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Bausch & Lomb Incorporated

INDUSTRY

Sponsor Role: collaborator

Massachusetts Eye and Ear Infirmary

OTHER

Sponsor Role: lead

Responsible Party

Reza Dana, MD

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Reza Dana, MD, MPH, MSc

Role: PRINCIPAL_INVESTIGATOR

Massachusetts Eye and Ear Infirmary

Locations

Massachusetts Eye & Ear Infirmary

Boston, Massachusetts, United States

Countries

United States

Other Identifiers

11-048H

Identifier Type: -

Identifier Source: org_study_id