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

Posterior Blepharoconjunctivitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01220258
• Other study ID #: P08641
• Secondary ID: 041-118
• Status: Terminated
• Phase: Phase 2
• First received: October 12, 2010
• Last updated: December 13, 2013
• Start date: November 2010
• Est. completion date: August 2011

Study information

• Verified date: December 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

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 29
• Est. completion date: August 2011
• Est. primary completion date: August 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Conjunctivitis
• Posterior Blepharoconjunctivitis

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)

Locations

Country	Name	City	State
United States	Baylor Eye Clinic, Alkek Eye Center of Baylor College of Medicine	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline of investigator-rated scores for eyelid margin erythema		Week 4	No
Secondary	Change from baseline of investigator-rated scores of blepharoconjunctivitis signs		Weeks 2, 4, 6, 8	No
Secondary	Change from baseline of subject-rated scores of blepharoconjunctivitis symptoms		Weeks 2, 4, 6, 8	No