Blepharitis
Conditions
Brief summary
The objective of this study is to compare the safety and efficacy of azithromycin ophthalmic solution, 1% versus placebo over a four-week treatment period.
Interventions
One drop in each eye twice a day for the first two days; then one drop in each eye once a day for 26 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 26 days
Sponsors
Merck Sharp & Dohme LLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
* 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Eyelid margin erythema | Four weeks |
Secondary
| Measure | Time frame |
|---|---|
| Signs and symptoms of Blepharitis | One week, two weeks, three weeks, four weeks, six weeks, eight weeks |
Countries
United States
Outcome results
None listed