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Study to Determine the Effect of Azasite on Corneal Surface Irregularity

Primary Purpose

Meibomian Gland Dysfunction

Status
Withdrawn
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Azasite
Sponsored by
Philadelphia Eye Associates
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

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Ability to provide informed consent prior to enrollment in study
  • Patient ability to follow study instructions and comply with all study protocols
  • Corneal irregularity measurement (CIM) > 1.7 in both eyes
  • Non-atrophic meibomian gland dysfunction (MGD) as defined by abnormal meibomian expression in at least 2 meibomian glands of the eyelids of each eye
  • At least two symptoms of at least moderate severity (≥ grade 2, 0 to 3 scale) as defined in the MGD Global Symptom Score (Itching, Foreign-body sensation, Dryness, Burning, Lid swelling)
  • Tear film break up time < 10 seconds
  • Schirmer with anesthesia > 5 mm
  • Best corrected distance visual acuity (BCDVA) > 20/100

Exclusion Criteria:

  • Cicatricial or atrophic meibomian gland dysfunction (MGD)
  • Any corneal disease or scar involving the central 6 mm, including epithelial basement membrane dystrophy, Salzmann nodular degeneration, recurrent erosions, keratoconus or ectasia
  • Use of azithromycin or doxycycline within 1 month of screening
  • Topical ocular antibiotic, anti-histamines, allergy, or steroid medication within 2 weeks of baseline (a 2 week washout after screening will be allowed)
  • Topical prostaglandin analogue use within 30 days of study
  • The anticipated use of any drops, gels or ointments during the study period outside of the study protocol
  • Use of eye make-up during study period
  • Active ocular infection or inflammation
  • History of herpetic eye disease or neurotrophic keratitis
  • Lid pathology (except MGD or blepharitis) that the examiner feels may affect the ocular surface
  • Significant conjunctival scars (ex. h/o SJS)
  • Pterygium
  • Lacrimal punctal occlusion within 2 months of screening
  • Ocular surgery within 1 year of screening
  • Monocular patients
  • Pregnant, breast-feeding, or sexually active females not using contraception
  • Uncontrolled systemic disease
  • Presence of any disease (medical or ocular) that, in the opinion of the investigator, may interfere with the study's safety or interpretation
  • Known allergy to the study medication or its components
  • Current enrollment in an investigational drug or device study within 30 days of screening for this study

Sites / Locations

  • Philadelphia Eye Associates

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Treatment eye

Durasite

Arm Description

Azasite (azithromycin ophthalmic 1%) twice a day for 2 days followed by nightly for 4 weeks

Vehicle of Azasite used as placebo

Outcomes

Primary Outcome Measures

Change in Corneal Irregularity Measurement
Topographically defined corneal smoothness as compared to baseline measurement at day 0

Secondary Outcome Measures

Global symptoms score
0-3 score of itching, foreign body sensation, dryness, burning and swelling as compared to baseline measurement at day 0
Meibomian gland secretion characteristics
Meibum secretions of the eyelids will be assessed at each visit by pressing on the lower or upper lid (with a finger) until excretions are seen from at least 2 meibomian glands. The following scale, based on a scale in a study by Mathers et al (Mathers et al. Meibomian Gland Dysfunction in Chronic Blepharitis. Cornea .1991;10(4): 277-285.) will be used: NE= <2 glands expressible = Atrophic or Cicatricial MGD (exclusion at Visit 1 and 2) 0= clear secretion (normal) opaque secretion with normal viscosity opaque secretion with increased viscosity severely thickened secretion, toothpaste consistency At each time point, these characteristics will be compared to baseline at day 0.
Best corrected distance visual acuity
as compared to baseline measurement at day 0
Corneal staining
Using NEI industry workshop scale. Scores will be compared to baseline measurement at day 0
Axial topography based astigmatism pattern
Patterns will be compared to baseline at day 0. All topography testing will be performed using the same machine and system, the Carl Zeiss Meditec Atlas, Model 9000, system 3.0.0.39. The topographic pattern will be reviewed by a masked investigator (masked to eye randomization), and categorized as one of the following: Normal/Symmetrical: Includes round, oval, or symmetric bowtie patterns Asymmetric bowtie: Differentiated from symmetric bowtie by a difference between axial keratometry readings along the two lobes of >1D at points 1.5mm from the center, or a difference in the widths of the lobes of the bowties at that distance of >33%. Irregular: Includes skewed radial axis (skewing by >20%), inferior or superior steepening (I-S asymmetry >1.2D); or a pattern that does not fit either 1 or 2 above.
Intraocular Lens(IOL) Master Keratometry
As compared to baseline at day 0.
Change in Corneal Irregularity Measurement
Topographically defined corneal smoothness as compared to baseline measurement at day 0

Full Information

First Posted
January 30, 2013
Last Updated
September 27, 2016
Sponsor
Philadelphia Eye Associates
Collaborators
Merck Sharp & Dohme LLC, Thomas Jefferson University
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1. Study Identification

Unique Protocol Identification Number
NCT01797107
Brief Title
Study to Determine the Effect of Azasite on Corneal Surface Irregularity
Official Title
A Randomized, Double-Blind, Placebo-Controlled Study to Determine the Effect of Azasite on Corneal Surface Irregularity in Subjects With Meibomian Gland Dysfunction
Study Type
Interventional

2. Study Status

Record Verification Date
April 2015
Overall Recruitment Status
Withdrawn
Why Stopped
Lack of enrollment
Study Start Date
March 2013 (undefined)
Primary Completion Date
July 2014 (Actual)
Study Completion Date
July 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Philadelphia Eye Associates
Collaborators
Merck Sharp & Dohme LLC, Thomas Jefferson University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this study is to evaluate the effect of Azasite on patients with corneal surface irregularity (meibomian gland dysfunction).
Detailed Description
This will be a single-center, randomized, vehicle-controlled, double-masked, clinical trial comparing a four week course of Azasite (azithromycin ophthalmic 1%) to vehicle (Durasite®) in patients with MGD-related evaporative dry eye. All patients will be evaluated at screening, baseline, two weeks, four weeks, and six weeks. The primary outcome measure will be improvement, as compared to baseline, in corneal irregularity as measured by a topographically-derived value, the Corneal Irregularity Measurement (CIM). Secondary outcome measures will be a global symptom score, tear film break up time, meibomian gland secretion characteristics, best-corrected distance visual acuity, corneal staining, axial topography based astigmatism patterns, and IOL Master keratometry. We will enroll 60 eyes of 30 patients, and each patient will be randomly assigned to receive Azasite in one eye and vehicle (Durasite®) in the fellow eye.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Meibomian Gland Dysfunction
Keywords
Meibomian gland dysfunction

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment eye
Arm Type
Experimental
Arm Description
Azasite (azithromycin ophthalmic 1%) twice a day for 2 days followed by nightly for 4 weeks
Arm Title
Durasite
Arm Type
Placebo Comparator
Arm Description
Vehicle of Azasite used as placebo
Intervention Type
Drug
Intervention Name(s)
Azasite
Other Intervention Name(s)
Azithromycin ophthalmic 1%
Intervention Description
Patients will be given 1 drop twice a day for 2 days followed by 1 drop nightly for 4 weeks.
Primary Outcome Measure Information:
Title
Change in Corneal Irregularity Measurement
Description
Topographically defined corneal smoothness as compared to baseline measurement at day 0
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Global symptoms score
Description
0-3 score of itching, foreign body sensation, dryness, burning and swelling as compared to baseline measurement at day 0
Time Frame
2,4 and 6 weeks
Title
Meibomian gland secretion characteristics
Description
Meibum secretions of the eyelids will be assessed at each visit by pressing on the lower or upper lid (with a finger) until excretions are seen from at least 2 meibomian glands. The following scale, based on a scale in a study by Mathers et al (Mathers et al. Meibomian Gland Dysfunction in Chronic Blepharitis. Cornea .1991;10(4): 277-285.) will be used: NE= <2 glands expressible = Atrophic or Cicatricial MGD (exclusion at Visit 1 and 2) 0= clear secretion (normal) opaque secretion with normal viscosity opaque secretion with increased viscosity severely thickened secretion, toothpaste consistency At each time point, these characteristics will be compared to baseline at day 0.
Time Frame
2, 4 and 6 weeks
Title
Best corrected distance visual acuity
Description
as compared to baseline measurement at day 0
Time Frame
2, 4 and 6 weeks
Title
Corneal staining
Description
Using NEI industry workshop scale. Scores will be compared to baseline measurement at day 0
Time Frame
2, 4 and 6 weeks
Title
Axial topography based astigmatism pattern
Description
Patterns will be compared to baseline at day 0. All topography testing will be performed using the same machine and system, the Carl Zeiss Meditec Atlas, Model 9000, system 3.0.0.39. The topographic pattern will be reviewed by a masked investigator (masked to eye randomization), and categorized as one of the following: Normal/Symmetrical: Includes round, oval, or symmetric bowtie patterns Asymmetric bowtie: Differentiated from symmetric bowtie by a difference between axial keratometry readings along the two lobes of >1D at points 1.5mm from the center, or a difference in the widths of the lobes of the bowties at that distance of >33%. Irregular: Includes skewed radial axis (skewing by >20%), inferior or superior steepening (I-S asymmetry >1.2D); or a pattern that does not fit either 1 or 2 above.
Time Frame
2, 4 and 6 weeks
Title
Intraocular Lens(IOL) Master Keratometry
Description
As compared to baseline at day 0.
Time Frame
2, 4 and 6 weeks
Title
Change in Corneal Irregularity Measurement
Description
Topographically defined corneal smoothness as compared to baseline measurement at day 0
Time Frame
2 weeks, 6 weeks
Other Pre-specified Outcome Measures:
Title
Tear film break-up time
Description
Fluorescein break up time
Time Frame
2, 4 and 6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Ability to provide informed consent prior to enrollment in study Patient ability to follow study instructions and comply with all study protocols Corneal irregularity measurement (CIM) > 1.7 in both eyes Non-atrophic meibomian gland dysfunction (MGD) as defined by abnormal meibomian expression in at least 2 meibomian glands of the eyelids of each eye At least two symptoms of at least moderate severity (≥ grade 2, 0 to 3 scale) as defined in the MGD Global Symptom Score (Itching, Foreign-body sensation, Dryness, Burning, Lid swelling) Tear film break up time < 10 seconds Schirmer with anesthesia > 5 mm Best corrected distance visual acuity (BCDVA) > 20/100 Exclusion Criteria: Cicatricial or atrophic meibomian gland dysfunction (MGD) Any corneal disease or scar involving the central 6 mm, including epithelial basement membrane dystrophy, Salzmann nodular degeneration, recurrent erosions, keratoconus or ectasia Use of azithromycin or doxycycline within 1 month of screening Topical ocular antibiotic, anti-histamines, allergy, or steroid medication within 2 weeks of baseline (a 2 week washout after screening will be allowed) Topical prostaglandin analogue use within 30 days of study The anticipated use of any drops, gels or ointments during the study period outside of the study protocol Use of eye make-up during study period Active ocular infection or inflammation History of herpetic eye disease or neurotrophic keratitis Lid pathology (except MGD or blepharitis) that the examiner feels may affect the ocular surface Significant conjunctival scars (ex. h/o SJS) Pterygium Lacrimal punctal occlusion within 2 months of screening Ocular surgery within 1 year of screening Monocular patients Pregnant, breast-feeding, or sexually active females not using contraception Uncontrolled systemic disease Presence of any disease (medical or ocular) that, in the opinion of the investigator, may interfere with the study's safety or interpretation Known allergy to the study medication or its components Current enrollment in an investigational drug or device study within 30 days of screening for this study
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Brad H Feldman, MD
Organizational Affiliation
Philadelphia Eye Associates
Official's Role
Principal Investigator
Facility Information:
Facility Name
Philadelphia Eye Associates
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19148
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Study to Determine the Effect of Azasite on Corneal Surface Irregularity

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