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

Primary Purpose

Meibomian Gland Dysfunction, Posterior Blepharitis

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Loteprednol/tobramycin
Loteprednol
B+L Advanced Eye Relief Lubricant Drop
Sponsored by
Massachusetts Eye and Ear Infirmary
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Meibomian Gland Dysfunction focused on measuring Meibomian gland dysfunction, Blepharitis, Dry Eye, Ocular Inflammation, MGD, Zylet, Lotemax, Artificial Tear

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Massachusetts Eye & Ear Infirmary

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Placebo Comparator

Arm Label

Zylet

Lotemax

B+L Advanced Eye Relief Lubricant Drop

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

Ocular Surface Disease Index
OSDI is a 12-question survey used to measure the symptoms of dry eye disease. Each of the 12 individual questions rate one symptom on a 0-4 scale, with 4 meaning that the symptom is present all of the time and 0 meaning the symptom is present none of the time. The overall ODSI score is calculated by adding all of the values from the 12 questions, multiplying that value by 25, and dividing the resulting value by the number of questions answered. This results in an overall scale that ranges from 0-100, with 100 being severe dry eye symptoms and 0 being no dry eye symptoms.
Symptom Assessment iN Dry Eye (SANDE) Frequency Score
Questionnaire given to patients to assess the frequency of dry eye symptoms. The questionnaire utilizes a 100 mm horizontal Visual Analogue Scale technique to quantify the frequency of the patient's dry eye symptoms. Change is quantified from baseline to week 4. The range of the SANDE frequency scale is 0-100, with 0 being the minimum level of frequency of dry eye symptoms and 100 being the maximum level of frequency of dry eye symptoms.
Symptom Assessment iN Dry Eye (SANDE) Severity Score
Questionnaire given to patients to assess the severity of dry eye symptoms. The questionnaire utilizes a 100 mm horizontal Visual Analogue Scale technique to quantify the severity of the patient's dry eye symptoms. Change is quantified from baseline to week 4. The range of the SANDE severity scale is 0-100, with minimum level of severity of dry eye symptoms and 100 being the maximum level of severity of dry eye symptoms.
Corneal Fluorescein Staining Score
Corneal Fluorescein Staining is used to assess the level of corneal epitheliopathy that is related to dry eye disease. The CFS scale ranges from 0 to 15 scale, with 0 representing the minimum level of corneal epitheliopathy and 15 representing the maximum level of corneal epitheliopathy.

Secondary Outcome Measures

Full Information

First Posted
August 2, 2011
Last Updated
July 6, 2017
Sponsor
Massachusetts Eye and Ear Infirmary
Collaborators
Bausch & Lomb Incorporated
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1. Study Identification

Unique Protocol Identification Number
NCT01456780
Brief Title
Efficacy of Zylet vs. Lotemax for the Treatment of Ocular Surface Inflammation/MGD/Blepharitis
Acronym
ZvL
Official Title
Relative Efficacy of Loteprednol (Lotemax®) vs. Loteprednol/Tobramycin (Zylet®) in Treatment of Chronic Ocular Surface Inflammation Associated With Meibomian Gland Dysfunction (MGD)/Posterior Blepharitis
Study Type
Interventional

2. Study Status

Record Verification Date
July 2017
Overall Recruitment Status
Completed
Study Start Date
August 2011 (Actual)
Primary Completion Date
March 2013 (Actual)
Study Completion Date
June 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Massachusetts Eye and Ear Infirmary
Collaborators
Bausch & Lomb Incorporated

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Meibomian Gland Dysfunction, Posterior Blepharitis
Keywords
Meibomian gland dysfunction, Blepharitis, Dry Eye, Ocular Inflammation, MGD, Zylet, Lotemax, Artificial Tear

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Zylet
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Lotemax
Arm Type
Active Comparator
Arm Description
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.
Arm Title
B+L Advanced Eye Relief Lubricant Drop
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Loteprednol/tobramycin
Other Intervention Name(s)
Zylet
Intervention Description
Zylet (loteprednol/tobramycin) drops, 1 drop twice a day for 4 weeks.
Intervention Type
Drug
Intervention Name(s)
Loteprednol
Other Intervention Name(s)
Lotemax
Intervention Description
Eye drops, 1 drop twice a day for 4 weeks
Intervention Type
Drug
Intervention Name(s)
B+L Advanced Eye Relief Lubricant Drop
Other Intervention Name(s)
artificial tears
Intervention Description
Bausch + Lomb (B+L) Advanced Eye Relief Lubricant Drop (Artificial Tears), 1 drop twice a day for 4 weeks.
Primary Outcome Measure Information:
Title
Ocular Surface Disease Index
Description
OSDI is a 12-question survey used to measure the symptoms of dry eye disease. Each of the 12 individual questions rate one symptom on a 0-4 scale, with 4 meaning that the symptom is present all of the time and 0 meaning the symptom is present none of the time. The overall ODSI score is calculated by adding all of the values from the 12 questions, multiplying that value by 25, and dividing the resulting value by the number of questions answered. This results in an overall scale that ranges from 0-100, with 100 being severe dry eye symptoms and 0 being no dry eye symptoms.
Time Frame
Week 4 Time Point
Title
Symptom Assessment iN Dry Eye (SANDE) Frequency Score
Description
Questionnaire given to patients to assess the frequency of dry eye symptoms. The questionnaire utilizes a 100 mm horizontal Visual Analogue Scale technique to quantify the frequency of the patient's dry eye symptoms. Change is quantified from baseline to week 4. The range of the SANDE frequency scale is 0-100, with 0 being the minimum level of frequency of dry eye symptoms and 100 being the maximum level of frequency of dry eye symptoms.
Time Frame
Week 4 Time Point
Title
Symptom Assessment iN Dry Eye (SANDE) Severity Score
Description
Questionnaire given to patients to assess the severity of dry eye symptoms. The questionnaire utilizes a 100 mm horizontal Visual Analogue Scale technique to quantify the severity of the patient's dry eye symptoms. Change is quantified from baseline to week 4. The range of the SANDE severity scale is 0-100, with minimum level of severity of dry eye symptoms and 100 being the maximum level of severity of dry eye symptoms.
Time Frame
Week 4 Time Point
Title
Corneal Fluorescein Staining Score
Description
Corneal Fluorescein Staining is used to assess the level of corneal epitheliopathy that is related to dry eye disease. The CFS scale ranges from 0 to 15 scale, with 0 representing the minimum level of corneal epitheliopathy and 15 representing the maximum level of corneal epitheliopathy.
Time Frame
Week 4 Time Point

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Reza Dana, MD, MPH, MSc
Organizational Affiliation
Massachusetts Eye and Ear Infirmary
Official's Role
Principal Investigator
Facility Information:
Facility Name
Massachusetts Eye & Ear Infirmary
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes

Learn more about this trial

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

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