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

Primary Purpose

Dry Eye Disease

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Azithromycin Ophthalmic Solution, 1%
Placebo
Sponsored by
Merck Sharp & Dohme LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dry Eye Disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Sall Research Medical Center, Inc.
  • David Wirta, MD, Inc.
  • North Bay Eye Associates, Inc.
  • Kentucky Lions Eye Center
  • Tauber Eye Center
  • Ophthalmology Associates
  • Abrams Eye Center
  • OSU - College of Optometry
  • Eye Clinics of South Texas

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Azithromycin Ophthalmic Solution, 1%

Placebo

Arm Description

Outcomes

Primary Outcome Measures

Tear Break-Up Time (TBUT)

Secondary Outcome Measures

Corneal Staining
Tear Volume
Meibomian gland plugging
Subject-rated scores of dry eye symptoms

Full Information

First Posted
November 12, 2009
Last Updated
September 20, 2011
Sponsor
Merck Sharp & Dohme LLC
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1. Study Identification

Unique Protocol Identification Number
NCT01014078
Brief Title
A Four Week Study of Azithromycin Ophthalmic Solution, 1% Versus Placebo in Subjects With Dry Eye Disease
Study Type
Interventional

2. Study Status

Record Verification Date
September 2011
Overall Recruitment Status
Completed
Study Start Date
October 2009 (undefined)
Primary Completion Date
March 2010 (Actual)
Study Completion Date
March 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Merck Sharp & Dohme LLC

4. Oversight

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dry Eye Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
112 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Azithromycin Ophthalmic Solution, 1%
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Azithromycin Ophthalmic Solution, 1%
Intervention Description
1 drop BID for the first 2 days and then 1 drop once a day for the remainder of the study (29 ± 1 days)
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
1 drop BID for the first 2 days and then 1 drop once a day for the remainder of the study (29 ± 1 days)
Primary Outcome Measure Information:
Title
Tear Break-Up Time (TBUT)
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Corneal Staining
Time Frame
4 weeks
Title
Tear Volume
Time Frame
4 weeks
Title
Meibomian gland plugging
Time Frame
4 weeks
Title
Subject-rated scores of dry eye symptoms
Time Frame
4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Reza Haque, MD, PhD
Organizational Affiliation
Medical Monitor
Official's Role
Study Chair
Facility Information:
Facility Name
Sall Research Medical Center, Inc.
City
Artesia
State/Province
California
ZIP/Postal Code
90701
Country
United States
Facility Name
David Wirta, MD, Inc.
City
Newport Beach
State/Province
California
ZIP/Postal Code
92663
Country
United States
Facility Name
North Bay Eye Associates, Inc.
City
Petaluma
State/Province
California
ZIP/Postal Code
94954
Country
United States
Facility Name
Kentucky Lions Eye Center
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40207
Country
United States
Facility Name
Tauber Eye Center
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64111
Country
United States
Facility Name
Ophthalmology Associates
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63131
Country
United States
Facility Name
Abrams Eye Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44115
Country
United States
Facility Name
OSU - College of Optometry
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Facility Name
Eye Clinics of South Texas
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78209
Country
United States

12. IPD Sharing Statement

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

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