A Four Week Study of Azithromycin Ophthalmic Solution, 1% Versus Vehicle in Subjects With Blepharitis (P08636)

Merck Sharp & Dohme (MSD)

Status and phase: Terminated; Phase 2

Conditions: Blepharitis

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT01269658

P08636

Details and patient eligibility

About

The purpose of this study is to compare the safety and efficacy of azithromycin ophthalmic solution, 1% versus vehicle over a four-week treatment period in treating the signs and symptoms of subjects with blepharitis and to evaluate the clinical course of the condition under study.

Enrollment: 40 patients

Sex: All

Ages: 14 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Have a current diagnosis of blepharitis
• Have a best corrected visual acuity (BCVA), using corrective lenses if

necessary, in both eyes of at least +0.7

If female, are non-pregnant or non-lactating

Exclusion criteria

• Have a concurrent acute hordeolum (stye) or chalazion
• Have inflammation of the ocular surface
• Have used artificial tears within 48 hours prior to Visit 1 or anticipate

using during the study

Have had ocular surgery in the past 90 days or will require it during the

study

• 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 been diagnosed with ongoing glaucoma
• Unable to withhold the use of ocular cosmetic products within 48 hours

prior to Visit 1 and throughout the study

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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40 participants in 2 patient groups, including a placebo group

Azithromycin ophthalmic solution, 1%

Experimental group

Treatment:

Drug: Azithromycin ophthalmic solution, 1%

Vehicle

Placebo Comparator group

Treatment:

Drug: Vehicle