A Four Week Study of Azithromycin Ophthalmic Solution, 1% Versus Placebo in Subjects With Dry Eye Disease
NCT ID: NCT01014078
Last Updated: 2011-09-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE4
112 participants
INTERVENTIONAL
2009-10-31
2010-03-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Azithromycin Ophthalmic Solution, 1%
Azithromycin Ophthalmic Solution, 1%
1 drop BID for the first 2 days and then 1 drop once a day for the remainder of the study (29 ± 1 days)
Placebo
Placebo
1 drop BID for the first 2 days and then 1 drop once a day for the remainder of the study (29 ± 1 days)
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Azithromycin Ophthalmic Solution, 1%
1 drop BID for the first 2 days and then 1 drop once a day for the remainder of the study (29 ± 1 days)
Placebo
1 drop BID for the first 2 days and then 1 drop once a day for the remainder of the study (29 ± 1 days)
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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 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.
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Merck Sharp & Dohme LLC
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Inspire
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Reza Haque, MD, PhD
Role: STUDY_CHAIR
Medical Monitor
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Sall Research Medical Center, Inc.
Artesia, California, United States
David Wirta, MD, Inc.
Newport Beach, California, United States
North Bay Eye Associates, Inc.
Petaluma, California, United States
Kentucky Lions Eye Center
Louisville, Kentucky, United States
Tauber Eye Center
Kansas City, Missouri, United States
Ophthalmology Associates
St Louis, Missouri, United States
Abrams Eye Center
Cleveland, Ohio, United States
OSU - College of Optometry
Columbus, Ohio, United States
Eye Clinics of South Texas
San Antonio, Texas, United States
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
P08646
Identifier Type: -
Identifier Source: secondary_id
041-116
Identifier Type: -
Identifier Source: org_study_id