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Meibomian Gland DysfunctionPhase 2NCT01797107

Study to Determine the Effect of Azasite on Corneal Surface Irregularity

A Phase 2 study testing Azasite in people with Meibomian Gland Dysfunction, run by Philadelphia Eye Associates at 1 site in United States.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

The purpose of this study is to evaluate the effect of Azasite on patients with corneal surface irregularity (meibomian gland dysfunction). Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Meibomian Gland Dysfunction
What is being tested?
Azasite
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
0 participants
Where
1 siteUnited States
Study dates
Mar 2013to Jul 2014
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
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  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Philadelphia Eye Associates

    Philadelphia, Pennsylvania, 19148

Other trials in United States

About this study

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

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

Read the 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.

Being tested
Azasite
Keywords
Meibomian gland dysfunction
Medical subject headings
Meibomian Gland Dysfunction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AzasiteDrug

    Also called Azithromycin ophthalmic 1%

    Patients will be given 1 drop twice a day for 2 days followed by 1 drop nightly for 4 weeks.

Study groups in NCT01797107
Study groupRoleWhat they receive
Treatment eyeExperimentalAzasite (azithromycin ophthalmic 1%) twice a day for 2 days followed by nightly for 4 weeks
Receives: Drug: Azasite
DurasitePlacebo comparatorVehicle of Azasite used as placebo
Receives: Drug: Azasite

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in Corneal Irregularity Measurement

    Topographically defined corneal smoothness as compared to baseline measurement at day 0

    Measured: 4 weeks

Secondary outcomes (7)

  1. Global symptoms score

    0-3 score of itching, foreign body sensation, dryness, burning and swelling as compared to baseline measurement at day 0

    Measured: 2,4 and 6 weeks

  2. 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.

    Measured: 2, 4 and 6 weeks

  3. Best corrected distance visual acuity

    as compared to baseline measurement at day 0

    Measured: 2, 4 and 6 weeks

  4. Corneal staining

    Using NEI industry workshop scale. Scores will be compared to baseline measurement at day 0

    Measured: 2, 4 and 6 weeks

  5. 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.

    Measured: 2, 4 and 6 weeks

  6. Intraocular Lens(IOL) Master Keratometry

    As compared to baseline at day 0.

    Measured: 2, 4 and 6 weeks

  7. Change in Corneal Irregularity Measurement

    Topographically defined corneal smoothness as compared to baseline measurement at day 0

    Measured: 2 weeks, 6 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Feb 2013 (estimated)
  2. Study startMar 2013
  3. Primary completionJul 2014
  4. Study completionJul 2014

Why it stopped: Lack of enrollment

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Single group
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01797107
Sponsor's protocol ID
40958
Status last verified
Apr 2015
First submitted
30 Jan 2013
Last updated
28 Sep 2016
Results posted
No
Data monitoring committee
Yes
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Azasite in people with Meibomian Gland Dysfunction, run by Philadelphia Eye Associates at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 28 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Corneal Irregularity Measurement (time frame: 4 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01797107.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2016.

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