CClinicalTrials.gg
CompletedNCT00892970Updated Sep 26, 2011

The Effects of Azithromycin Ophthalmic Solution, 1% Versus Placebo in Subjects With Blepharitis During a Two-Week Treatment Period

A Phase 2 interventional study of Azithromycin ophthalmic solution, 1% and Placebo in Blepharitis, sponsored by Merck Sharp & Dohme LLC. Completed at 33 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2011-09-26.

Sponsored by Merck Sharp & Dohme LLC · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
313
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

The objective of this study is to compare the safety and efficacy of azithromycin ophthalmic solution, 1% versus placebo over a two-week treatment period.

02

Conditions studied

  • Blepharitis

Browse trials for

03

In context

Blepharitis

70 studies on the registry are indexed under Blepharitis; 5 are open to participants now.

This study's enrollment of 313 is above the median of 60 across 62 interventional studies indexed under Blepharitis.

Browse Blepharitis studies →

Lead sponsor

Merck Sharp & Dohme LLC is the lead sponsor of 2,114 studies on the registry; 133 are open to participants now.

Of its 489 completed or terminated interventional studies of FDA-regulated products, 362 (74%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Have best corrected visual acuity in both eyes of at least +0.7 or better
  • If female, are non-pregnant or non-lactating
  • Have a current diagnosis of blepharitis in one or both eyes

Exclusion criteria

Exclusion Criteria:

  • Have lid structural abnormalities
  • Have suspected ocular fungal or viral infection
  • Have practiced warm compress therapy within 14 days prior to Visit 2
  • Unable to withhold the use of contact lenses during the treatment or follow-up periods
  • Unable to withhold the use of ocular cosmetic products within 24 hours prior to study visits
  • Have had penetrating intraocular surgery within 90 days prior to Visit 2
  • Have had ocular surface surgery within the past year prior to Visit 2
  • Have a serious medical condition which could confound study assessments
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
313 participants (actual)

Study arms

  • Experimental
    1

    Drug: Azithromycin ophthalmic solution, 1%

  • Placebo comparator
    2

    Drug: Placebo

Interventions

  • DrugAzithromycin ophthalmic solution, 1%

    One drop in each eye twice a day for the first two days; then one drop in each eye once a day for 12 days

  • DrugPlacebo

    One drop in each eye twice a day for the first two days; then one drop in each eye once a day for 12 days

06

What researchers measure

Primary outcomes

  1. Eyelid margin erythema

    Time frame: Two weeks

Secondary outcomes

  1. Signs and symptoms of Blepharitis

    Time frame: One week, two weeks, three weeks, four weeks

07

Study locations

33 sites
  • Jones Eye Institute
    Little Rock, Arkansas 72205, United States
  • Sall Medical Research Center
    Artesia, California 90701, United States
  • Milton Hom, OD
    Azusa, California 91702, United States
  • The Jules Stein Eye Institute UCLA Laser Refractive Center
    Los Angeles, California 90095, United States
  • North Valley Eye Medical Group
    Mission Hills, California 91345, United States
  • David Wirta, MD, Inc.
    Newport Beach, California 92663, United States
  • North Bay Eye Associates
    Petaluma, California 94954, United States
  • West Coast Eye Care
    San Diego, California 92115-1754, United States
  • Wolstan Eye Associates
    Torrence, California 90505, United States
  • Eye Center - A Medical and Surgical Group
    Hamden, Connecticut 06518, United States
  • Florida Eye Microsurgical Institute
    Boynton Beach, Florida 33426, United States
  • Eye Centers of Florida
    Fort Myers, Florida 33901, United States
  • NorthShore University HealthSystems
    Glenview, Illinois 60025, United States
  • Chicago Cornea Consultants
    Hoffman Estates, Illinois 60169, United States
  • Indiana University School of Medicine, Ophthalmology Dept.
    Indianapolis, Indiana 46202, United States
  • Eye Physicians and Surgeons, LLP
    Iowa City, Iowa 52245, United States
  • Koffler Vision Group
    Lexington, Kentucky 40509, United States
  • Wilmer Eye Institute, Johns Hopkins Hospital
    Baltimor, Maryland 21287, United States
  • Ophthalmic Consultants of Boston
    Boston, Massachusetts 02114, United States
  • Minnesota Eye Consultants
    Minneapolis, Minnesota 55404, United States
  • Ophthalmology Associates
    St. Louis, Missouri 63131, United States
  • Ophthalmology Consultants
    St. Louis, Missouri 63131, United States
  • Brar-Parekh Eye Associates
    West Paterson, New Jersey 07424, United States
  • South Shore Eye Care
    Wantagh, New York 11793, United States
  • Mundorf Eye Center
    Charlotte, North Carolina 28204, United States
  • TLC Laser Eye Center
    Greensboro, North Carolina 27410, United States
  • Cornerstone Eye Care
    High Point, North Carolina 27262, United States
  • Abrams Eye Center
    Cleveland, Ohio 44115, United States
  • Bucci Laser Vision Institute
    Wilkes-Barre, Pennsylvania 18702, United States
  • McCabe Vision Center
    Murfreesboro, Tennessee 37129, United States
  • Eye Clinic of Austin
    Austin, Texas 78731, United States
  • See Clearly Vision Group
    McLean, Virginia 22101, United States
  • Virginia Eye Consultants
    Norfolk, Virginia 23502, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 26, 2011, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00892970
Lead sponsor
Merck Sharp & Dohme LLC
First posted
May 5, 2009
Start date
Apr 2009
Primary completion
Jan 2010
Completion
Jan 2010
Last update
Sep 26, 2011

Study contacts

Reza Haque, MD, PhD
study chair · Medical Monitor, Inspire
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2011. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion