Clinical trial NCT01014078: A Four Week Study of Azithromycin Ophthalmic Solution, 1% Versus Placebo in Subjects With Dry Eye Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Dry Eye Disease
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2009-11-16
Enrollment: 112
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The objective of this study is to compare the safety and efficacy of azithromycin ophthalmic solution, 1% in dry eye subjects over a four week treatment period, using placebo as a comparison.


Eligibility criteria: Inclusion Criteria:

* Have a current diagnosis of dry eye in one or both eyes
* Moderate to severe degree of meibomian gland plugging
* Have best corrected visual acuity in both eyes of at least +0.7 LogMAR
* If female, are non-pregnant or non-lactating

Exclusion Criteria:

* Have anterior blepharitis
* Have lid structural abnormalities
* Have suspected ocular fungal or viral infection
* Have had penetrating intraocular surgery in the past 90 days or require penetrating intraocular surgery during the study
* Have had ocular surface surgery \[e.g., laser-assisted in situ keratomileusis (LASIK), refractive, pterygium\] within the past year.
* Unable to withhold the use of contact lenses during the study
* Have a known hypersensitivity to azithromycin, erythromycin, any other macrolide antibiotic, or any of the other ingredients in the study medication.
* Have a history of post vitreous detachment.
* Are considered legally blind in 1 eye (LogMAR BCVA= 1.0 or Snellen BCVA= 20/200).
* Have permanent conjunctival goblet cell loss or scarring conditions, including cicatricial blepharitis or conjunctivitis.
* Have a congenitally absent meibomian gland or lacrimal gland.
* Have had cauterization of the punctum or have had punctal plugs (silicone or collagen) inserted or removed within the 90 days prior to the screening.
* Have a serious medical condition which would confound study assessments.
* Have a concomitant ocular pathology that, in the opinion of the investigator, may confound study assessments.

Primary outcomes:
measure: Tear Break-Up Time (TBUT)
timeFrame: 4 weeks
Secondary outcomes:
measure: Corneal Staining
timeFrame: 4 weeks
measure: Tear Volume
timeFrame: 4 weeks
measure: Meibomian gland plugging
timeFrame: 4 weeks
measure: Subject-rated scores of dry eye symptoms
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Artesia
country: United States
facility: Sall Research Medical Center, Inc.
state: California
city: Newport Beach
country: United States
facility: David Wirta, MD, Inc.
state: California
city: Petaluma
country: United States
facility: North Bay Eye Associates, Inc.
state: California
city: Louisville
country: United States
facility: Kentucky Lions Eye Center
state: Kentucky
city: Kansas City
country: United States
facility: Tauber Eye Center
state: Missouri
city: Saint Louis
country: United States
facility: Ophthalmology Associates
state: Missouri
city: Cleveland
country: United States
facility: Abrams Eye Center
state: Ohio
city: Columbus
country: United States
facility: OSU - College of Optometry
state: Ohio
city: San Antonio
country: United States
facility: Eye Clinics of South Texas
state: Texas
Study officials:
affiliation: Medical Monitor
name: Reza Haque, MD, PhD
role: STUDY_CHAIR
References: