The purpose of this study is to evaluate the effect of Azasite on patients with corneal surface irregularity (meibomian gland dysfunction).
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Patients will be given 1 drop twice a day for 2 days followed by 1 drop nightly for 4 weeks.
Philadelphia Eye Associates
Philadelphia, Pennsylvania, United States
Change in Corneal Irregularity Measurement
Topographically defined corneal smoothness as compared to baseline measurement at day 0
Time frame: 4 weeks
Global symptoms score
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
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) 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.
Time frame: 2, 4 and 6 weeks
Best corrected distance visual acuity
as compared to baseline measurement at day 0
Time frame: 2, 4 and 6 weeks
Corneal staining
Using NEI industry workshop scale. Scores will be compared to baseline measurement at day 0
Time frame: 2, 4 and 6 weeks
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: 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.
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Time frame: 2, 4 and 6 weeks
Intraocular Lens(IOL) Master Keratometry
As compared to baseline at day 0.
Time frame: 2, 4 and 6 weeks
Change in Corneal Irregularity Measurement
Topographically defined corneal smoothness as compared to baseline measurement at day 0
Time frame: 2 weeks, 6 weeks