A Four Week Study of Azithromycin Ophthalmic Solution, 1% Versus Placebo in Subjects With Dry Eye Disease

Dry Eye Disease Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01014078
• Other study ID #: 041-116
• Secondary ID: P08646
• Status: Completed
• Phase: Phase 4
• First received: November 12, 2009
• Last updated: September 20, 2011
• Start date: October 2009
• Est. completion date: March 2010

Study information

• Verified date: September 2011
• 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 objective of this study is to compare the safety and efficacy of azithromycin ophthalmic solution, 1% in dry eye subjects over a four week treatment period, using placebo as a comparison.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 112
• Est. completion date: March 2010
• Est. primary completion date: March 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Have a current diagnosis of dry eye in one or both eyes

• Moderate to severe degree of meibomian gland plugging

• Have best corrected visual acuity 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 suspected ocular fungal or viral infection

• Have had penetrating intraocular surgery in the past 90 days or require penetrating intraocular surgery during the study

• Have had ocular surface surgery [e.g., laser-assisted in situ keratomileusis (LASIK), refractive, pterygium] within the past year.

• 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 a history of post vitreous detachment.

• Are considered legally blind in 1 eye (LogMAR BCVA= 1.0 or Snellen BCVA= 20/200).

• Have permanent conjunctival goblet cell loss or scarring conditions, including cicatricial blepharitis or conjunctivitis.

• Have a congenitally absent meibomian gland or lacrimal gland.

• Have had cauterization of the punctum or have had punctal plugs (silicone or collagen) inserted or removed within the 90 days prior to the screening.

• Have a serious medical condition which would confound study assessments.

• Have a concomitant ocular pathology that, in the opinion of the investigator, may confound study assessments.

Study Design

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

Related Conditions & MeSH terms

• Dry Eye Disease
• Eye Diseases

Intervention

Drug:
• Azithromycin Ophthalmic Solution, 1%
1 drop BID for the first 2 days and then 1 drop once a day for the remainder of the study (29 ± 1 days)
• Placebo
1 drop BID for the first 2 days and then 1 drop once a day for the remainder of the study (29 ± 1 days)

Locations

Country	Name	City	State
United States	Sall Research Medical Center, Inc.	Artesia	California
United States	Abrams Eye Center	Cleveland	Ohio
United States	OSU - College of Optometry	Columbus	Ohio
United States	Tauber Eye Center	Kansas City	Missouri
United States	Kentucky Lions Eye Center	Louisville	Kentucky
United States	David Wirta, MD, Inc.	Newport Beach	California
United States	North Bay Eye Associates, Inc.	Petaluma	California
United States	Ophthalmology Associates	Saint Louis	Missouri
United States	Eye Clinics of South Texas	San Antonio	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	Tear Break-Up Time (TBUT)		4 weeks	No
Secondary	Corneal Staining		4 weeks	No
Secondary	Tear Volume		4 weeks	No
Secondary	Meibomian gland plugging		4 weeks	No
Secondary	Subject-rated scores of dry eye symptoms		4 weeks	No