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Study to Determine the Effect of Azasite on Corneal Surface Irregularity

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ClinicalTrials.gov Identifier: NCT01797107
Recruitment Status : Withdrawn (Lack of enrollment)
First Posted : February 22, 2013
Last Update Posted : September 28, 2016
Sponsor:
Collaborators:
Merck Sharp & Dohme Corp.
Thomas Jefferson University
Information provided by (Responsible Party):
Philadelphia Eye Associates

Brief Summary:
The purpose of this study is to evaluate the effect of Azasite on patients with corneal surface irregularity (meibomian gland dysfunction).

Condition or disease Intervention/treatment Phase
Meibomian Gland Dysfunction Drug: Azasite Phase 2

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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 Start Date : March 2013
Actual Primary Completion Date : July 2014
Actual Study Completion Date : July 2014

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Treatment eye
Azasite (azithromycin ophthalmic 1%) twice a day for 2 days followed by nightly for 4 weeks
Drug: Azasite
Patients will be given 1 drop twice a day for 2 days followed by 1 drop nightly for 4 weeks.
Other Name: Azithromycin ophthalmic 1%

Placebo Comparator: Durasite
Vehicle of Azasite used as placebo
Drug: Azasite
Patients will be given 1 drop twice a day for 2 days followed by 1 drop nightly for 4 weeks.
Other Name: Azithromycin ophthalmic 1%




Primary Outcome Measures :
  1. Change in Corneal Irregularity Measurement [ Time Frame: 4 weeks ]
    Topographically defined corneal smoothness as compared to baseline measurement at day 0


Secondary Outcome Measures :
  1. Global symptoms score [ Time Frame: 2,4 and 6 weeks ]
    0-3 score of itching, foreign body sensation, dryness, burning and swelling as compared to baseline measurement at day 0

  2. Meibomian gland secretion characteristics [ Time Frame: 2, 4 and 6 weeks ]

    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)

    1. opaque secretion with normal viscosity
    2. opaque secretion with increased viscosity
    3. severely thickened secretion, toothpaste consistency At each time point, these characteristics will be compared to baseline at day 0.

  3. Best corrected distance visual acuity [ Time Frame: 2, 4 and 6 weeks ]
    as compared to baseline measurement at day 0

  4. Corneal staining [ Time Frame: 2, 4 and 6 weeks ]
    Using NEI industry workshop scale. Scores will be compared to baseline measurement at day 0

  5. Axial topography based astigmatism pattern [ Time Frame: 2, 4 and 6 weeks ]

    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:

    1. Normal/Symmetrical: Includes round, oval, or symmetric bowtie patterns
    2. 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%.
    3. 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.

  6. Intraocular Lens(IOL) Master Keratometry [ Time Frame: 2, 4 and 6 weeks ]
    As compared to baseline at day 0.

  7. Change in Corneal Irregularity Measurement [ Time Frame: 2 weeks, 6 weeks ]
    Topographically defined corneal smoothness as compared to baseline measurement at day 0


Other Outcome Measures:
  1. Tear film break-up time [ Time Frame: 2, 4 and 6 weeks ]
    Fluorescein break up time



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01797107


Locations
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United States, Pennsylvania
Philadelphia Eye Associates
Philadelphia, Pennsylvania, United States, 19148
Sponsors and Collaborators
Philadelphia Eye Associates
Merck Sharp & Dohme Corp.
Thomas Jefferson University
Investigators
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Principal Investigator: Brad H Feldman, MD Philadelphia Eye Associates

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Responsible Party: Philadelphia Eye Associates
ClinicalTrials.gov Identifier: NCT01797107     History of Changes
Other Study ID Numbers: 40958
First Posted: February 22, 2013    Key Record Dates
Last Update Posted: September 28, 2016
Last Verified: April 2015
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Philadelphia Eye Associates:
Meibomian gland dysfunction
Additional relevant MeSH terms:
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Azithromycin
Anti-Bacterial Agents
Anti-Infective Agents