TerminatedPhase 2

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

United States29 participantsStarted 2010-11

Plain-language summary

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.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Change from baseline of investigator-rated scores for eyelid margin erythema

Timeframe: Week 4

Trial details

NCT IDNCT01220258

SponsorMerck Sharp & Dohme LLC

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2011-08

View on ClinicalTrials.gov More Posterior Blepharoconjunctivitis trials