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

A Randomized, Multi-Center, Double-Masked, Vehicle-Controlled, Parallel-Group, Safety and Efficacy Study of Azithromycin Ophthalmic Solution, 1% Versus Vehicle for Four Weeks in Subjects With Blepharitis

Status

Terminated

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01269658

Enrollment

Registered

2011-01-04

Start date

2010-12-31

Completion date

2011-06-30

Last updated

2013-11-21

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

Conditions

Blepharitis

Brief summary

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.

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)

DRUGVehicle

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

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

14 Years to 70 Years

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

Design outcomes

Primary

Measure	Time frame
Resolution of clinical signs of blepharitis	Day 28

Secondary

Measure	Time frame
Time to first clinical resolution	Days 7, 14, 21, 28, 42, 56, 70, and 84
Mean and change from baseline for clinical signs of blepharitis	Days 7, 14, 21, 28, 42, 56, 70, and 84
Mean and change from end of dosing for clinical signs of blepharitis	Days 42, 56, 70, and 84
Response to the Blepharitis Symptoms Questionnaire (BSQ)	Days 1, 7, 14, 21, 28, 42, 56, 70, and 84

Outcome results

None listed

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