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

NCT01456780 | Completed Phase 4 Results FDA Drug

• 1 other identifier: 11-048H
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Meibomian Gland Dysfunction; Posterior Blepharitis

Keywords

Meibomian gland dysfunction; Blepharitis; Dry Eye; Ocular Inflammation; MGD; Zylet; Lotemax; Artificial Tear

Outcome Measures

Primary Outcomes (4)

• 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.

  Week 4 Time Point

• 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.

  Week 4 Time Point

• 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.

  Week 4 Time Point

• 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.

  Week 4 Time Point

Study Arms (3)

Zylet

ACTIVE COMPARATOR

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.

Drug: Loteprednol/tobramycin

Lotemax

ACTIVE COMPARATOR

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.

Drug: Loteprednol

B+L Advanced Eye Relief Lubricant Drop

PLACEBO COMPARATOR

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.

Drug: B+L Advanced Eye Relief Lubricant Drop

Interventions

Loteprednol/tobramycin DRUG

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

Also known as: Zylet

Zylet

Loteprednol DRUG

Eye drops, 1 drop twice a day for 4 weeks

Also known as: Lotemax

Lotemax

B+L Advanced Eye Relief Lubricant Drop DRUG

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

Also known as: artificial tears

B+L Advanced Eye Relief Lubricant Drop

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Massachusetts Eye and Ear Infirmary: lead
• Bausch & Lomb Incorporated: collaborator

Study Sites (1)

Massachusetts Eye & Ear Infirmary

Boston, Massachusetts, 02114, United States

Location

MeSH Terms

Conditions

Meibomian Gland Dysfunction; Blepharitis; Dry Eye Syndromes

Interventions

Loteprednol Etabonate; Tobramycin; Lubricant Eye Drops

Condition Hierarchy (Ancestors)

Eyelid Diseases; Eye Diseases; Lacrimal Apparatus Diseases

Intervention Hierarchy (Ancestors)

Androstadienes; Androstenes; Androstanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Nebramycin; Kanamycin; Aminoglycosides; Glycosides; Carbohydrates; Ophthalmic Solutions; Pharmaceutical Solutions; Solutions; Pharmaceutical Preparations; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses; Lubricants; Specialty Uses of Chemicals

Results Point of Contact

• Title: Dr. Reza Dana
• Organization: Massachusetts Eye and Ear

Reza_Dana@meei.harvard.edu

617-573-4431

Study Officials

• Reza Dana, MD, MPH, MSc

  Massachusetts Eye and Ear Infirmary

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 2, 2011
• First Posted: October 21, 2011
• Study Start: August 1, 2011
• Primary Completion: March 1, 2013
• Study Completion: June 1, 2017
• Last Updated: August 1, 2017
• Results First Posted: June 19, 2017

Record last verified: 2017-07

Data Sharing

• IPD Sharing: Will share

Locations

US (1)