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

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.

Study Overview

• Status: Completed
• Conditions: Dry Eye Disease
• Intervention / Treatment: Drug: Azithromycin Ophthalmic Solution, 1%; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 112
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • California
    • Artesia, California, United States, 90701
      • Sall Research Medical Center, Inc.
    • Newport Beach, California, United States, 92663
      • David Wirta, MD, Inc.
    • Petaluma, California, United States, 94954
      • North Bay Eye Associates, Inc.
  • Kentucky
    • Louisville, Kentucky, United States, 40207
      • Kentucky Lions Eye Center
  • Missouri
    • Kansas City, Missouri, United States, 64111
      • Tauber Eye Center
    • Saint Louis, Missouri, United States, 63131
      • Ophthalmology Associates
  • Ohio
    • Cleveland, Ohio, United States, 44115
      • Abrams Eye Center
    • Columbus, Ohio, United States, 43210
      • OSU - College of Optometry
  • Texas
    • San Antonio, Texas, United States, 78209
      • Eye Clinics of South Texas

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
PLACEBO_COMPARATOR: Placebo	Drug: 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)
EXPERIMENTAL: Azithromycin Ophthalmic Solution, 1%	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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Tear Break-Up Time (TBUT)	4 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
Corneal Staining	4 weeks
Tear Volume	4 weeks
Meibomian gland plugging	4 weeks
Subject-rated scores of dry eye symptoms	4 weeks

Collaborators and Investigators

• Sponsor: Merck Sharp & Dohme LLC

Study record dates

Study Major Dates

• Study Start: October 1, 2009
• Primary Completion (ACTUAL): March 1, 2010
• Study Completion (ACTUAL): March 1, 2010

Study Registration Dates

• First Submitted: November 12, 2009
• First Submitted That Met QC Criteria: November 13, 2009
• First Posted (ESTIMATE): November 16, 2009

Study Record Updates

• Last Update Posted (ESTIMATE): September 26, 2011
• Last Update Submitted That Met QC Criteria: September 20, 2011
• Last Verified: September 1, 2011

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Lacrimal Apparatus Diseases; Keratoconjunctivitis; Conjunctivitis; Conjunctival Diseases; Keratitis; Corneal Diseases; Eye Diseases; Dry Eye Syndromes; Keratoconjunctivitis Sicca; Anti-Infective Agents; Anti-Bacterial Agents; Pharmaceutical Solutions; Ophthalmic Solutions; Azithromycin
• Other Study ID Numbers: 041-116; P08646