Dry Eye Disease
Conditions
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.
Interventions
1 drop BID for the first 2 days and then 1 drop once a day for the remainder of the study (29 ± 1 days)
DRUGPlacebo
1 drop BID for the first 2 days and then 1 drop once a day for the remainder of the study (29 ± 1 days)
Sponsors
Merck Sharp & Dohme LLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Tear Break-Up Time (TBUT) | 4 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Corneal Staining | 4 weeks |
| Tear Volume | 4 weeks |
| Meibomian gland plugging | 4 weeks |
| Subject-rated scores of dry eye symptoms | 4 weeks |
Countries
United States
Outcome results
None listed