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

Blepharitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01269658
• Other study ID #: P08636
• Secondary ID: P08636
• Status: Terminated
• Phase: Phase 2
• First received: December 21, 2010
• Last updated: October 29, 2013
• Start date: December 2010
• Est. completion date: June 2011

Study information

• Verified date: October 2013
• Source: Merck Sharp & Dohme Corp.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 40
• Est. completion date: June 2011
• Est. primary completion date: June 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 14 Years to 70 Years

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Blepharitis

Intervention

Drug:
• Azithromycin 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)
• Vehicle
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)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Resolution of clinical signs of blepharitis		Day 28	No
Secondary	Time to first clinical resolution		Days 7, 14, 21, 28, 42, 56, 70, and 84	No
Secondary	Mean and change from baseline for clinical signs of blepharitis		Days 7, 14, 21, 28, 42, 56, 70, and 84	No
Secondary	Mean and change from end of dosing for clinical signs of blepharitis		Days 42, 56, 70, and 84	No
Secondary	Response to the Blepharitis Symptoms Questionnaire (BSQ)		Days 1, 7, 14, 21, 28, 42, 56, 70, and 84	No