The Effects of Azithromycin Ophthalmic Solution, 1% Versus Placebo in Subjects With Blepharitis During a Four-Week Treatment Period (P08638)

Merck Sharp & Dohme (MSD)

Status and phase: Completed; Phase 2

Conditions: Blepharitis

Treatments: Drug: Azithromycin ophthalmic solution, 1%; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00894530

044-102

P08638

Details and patient eligibility

About

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.

Enrollment: 314 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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314 participants in 2 patient groups, including a placebo group

1

Experimental group

Treatment:

Drug: Azithromycin ophthalmic solution, 1%

2

Placebo Comparator group

Treatment:

Drug: Placebo