A Four Week Study of Azithromycin Ophthalmic Solution, 1% Versus Placebo in Subjects With Dry Eye Disease

Merck Sharp & Dohme (MSD)

Status and phase

Completed

Phase 4

Conditions

Dry Eye Disease

Treatments

Drug: Placebo

Drug: Azithromycin Ophthalmic Solution, 1%

Study type

Interventional

Funder types

Industry

Identifiers

NCT01014078

041-116

P08646

Details and patient eligibility

About

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.

Enrollment

112 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.