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

A Single-Center, Open-Label Study to Characterize Eyelid Margin Erythema, Markers of Clinical Inflammation and Levels of Inflammatory Mediators in the Lid Margins and Conjunctivae of Untreated Healthy Volunteers and Subjects Diagnosed With Posterior Blepharoconjunctivitis Following Dosing With Azithromycin Ophthalmic Solution, 1% for Four Weeks

Status

Terminated

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01220258

Enrollment

Registered

2010-10-13

Start date

2010-11-30

Completion date

2011-08-31

Last updated

2013-12-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Posterior Blepharoconjunctivitis

Brief 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.

Interventions

DRUGAzithromycin ophthalmic solution, 1%

1 drop twice daily (BID) for the first 2 days and then 1 drop once daily (QD) for the remainder of treatment period (approximately 28 days total)

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
Change from baseline of investigator-rated scores for eyelid margin erythema	Week 4

Secondary

Measure	Time frame
Change from baseline of investigator-rated scores of blepharoconjunctivitis signs	Weeks 2, 4, 6, 8
Change from baseline of subject-rated scores of blepharoconjunctivitis symptoms	Weeks 2, 4, 6, 8

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026