A Four Week, Open-Label Study of Azithromycin Ophthalmic Solution, 1% (P08641)

Merck Sharp & Dohme (MSD)

Status and phase: Terminated; Phase 2

Conditions: Posterior Blepharoconjunctivitis

Treatments: Drug: Azithromycin ophthalmic solution, 1%

Study type: Interventional

Funder types: Industry

Identifiers

NCT01220258

041-118

P08641

Details and patient eligibility

About

One objective of this study is to determine the levels of markers of inflammation on the eyelid margin of subjects with blepharoconjunctivitis and compare them with those of healthy volunteers. Another objective is to determine in subjects with blepharoconjunctivitis the effect of azithromycin ophthalmic solution, 1 % on markers of inflammation of lid margins and conjunctivae and on signs and symptoms of blepharoconjunctivitis.

Enrollment: 29 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Have a current diagnosis of posterior blepharoconjunctivitis in both eyes

(except for healthy volunteers)

• Have a Best Corrected Visual Acuity (BCVA), using corrective lenses if necessary, 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 had penetrating intraocular surgery in the past 90 days or require

penetrating intraocular surgery during the study

• Unable to withhold the use of contact lenses within 3 days prior to Visit 1

during the study

• Have been diagnosed with ongoing glaucoma
• Have a serious medical condition which could confound study assessments

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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29 participants in 1 patient group

Azithromycin ophthalmic solution, 1%

Experimental group

Treatment:

Drug: Azithromycin ophthalmic solution, 1%