NCT01797107

Brief Summary

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

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Mar 2013

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 30, 2013

Completed
23 days until next milestone

First Posted

Study publicly available on registry

February 22, 2013

Completed
7 days until next milestone

Study Start

First participant enrolled

March 1, 2013

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2014

Completed
Last Updated

September 28, 2016

Status Verified

April 1, 2015

Enrollment Period

1.3 years

First QC Date

January 30, 2013

Last Update Submit

September 27, 2016

Conditions

Meibomian Gland Dysfunction

Keywords

Meibomian gland dysfunction

Outcome Measures

Primary Outcomes (1)

  • Change in Corneal Irregularity Measurement

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

    4 weeks

Secondary Outcomes (7)

  • Global symptoms score

    2,4 and 6 weeks

  • Meibomian gland secretion characteristics

    2, 4 and 6 weeks

  • Best corrected distance visual acuity

    2, 4 and 6 weeks

  • Corneal staining

    2, 4 and 6 weeks

  • Axial topography based astigmatism pattern

    2, 4 and 6 weeks

  • +2 more secondary outcomes

Other Outcomes (1)

  • Tear film break-up time

    2, 4 and 6 weeks

Study Arms (2)

Treatment eye

EXPERIMENTAL

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

Drug: Azasite

Durasite

PLACEBO COMPARATOR

Vehicle of Azasite used as placebo

Drug: Azasite

Interventions

AzasiteDRUG

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

Also known as: Azithromycin ophthalmic 1%
DurasiteTreatment eye

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • +5 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Philadelphia Eye Associates

Philadelphia, Pennsylvania, 19148, United States

Location

MeSH Terms

Conditions

Meibomian Gland Dysfunction

Interventions

Azithromycin

Condition Hierarchy (Ancestors)

Eyelid DiseasesEye Diseases

Intervention Hierarchy (Ancestors)

ErythromycinMacrolidesPolyketidesLactonesOrganic Chemicals

Study Officials

  • Brad H Feldman, MD

    Philadelphia Eye Associates

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 30, 2013

First Posted

February 22, 2013

Study Start

March 1, 2013

Primary Completion

July 1, 2014

Study Completion

July 1, 2014

Last Updated

September 28, 2016

Record last verified: 2015-04

Data Sharing

IPD Sharing
Will not share

Locations

US(1)