A Four Week Study of Azithromycin Ophthalmic Solution, 1% Versus Vehicle in Subjects With Blepharitis (P08636)
Primary Purpose
Blepharitis
Status
Terminated
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Azithromycin ophthalmic solution, 1%
Vehicle
Sponsored by
About this trial
This is an interventional treatment trial for Blepharitis
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Azithromycin ophthalmic solution, 1%
Vehicle
Arm Description
Outcomes
Primary Outcome Measures
Resolution of clinical signs of blepharitis
Secondary Outcome Measures
Time to first clinical resolution
Mean and change from baseline for clinical signs of blepharitis
Mean and change from end of dosing for clinical signs of blepharitis
Response to the Blepharitis Symptoms Questionnaire (BSQ)
Full Information
NCT ID
NCT01269658
First Posted
December 21, 2010
Last Updated
October 29, 2013
Sponsor
Merck Sharp & Dohme LLC
1. Study Identification
Unique Protocol Identification Number
NCT01269658
Brief Title
A Four Week Study of Azithromycin Ophthalmic Solution, 1% Versus Vehicle in Subjects With Blepharitis (P08636)
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
Study Type
Interventional
2. Study Status
Record Verification Date
October 2013
Overall Recruitment Status
Terminated
Study Start Date
December 2010 (undefined)
Primary Completion Date
June 2011 (Actual)
Study Completion Date
June 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Merck Sharp & Dohme LLC
4. Oversight
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Blepharitis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Azithromycin ophthalmic solution, 1%
Arm Type
Experimental
Arm Title
Vehicle
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Azithromycin ophthalmic solution, 1%
Intervention Description
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)
Intervention Type
Drug
Intervention Name(s)
Vehicle
Intervention Description
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)
Primary Outcome Measure Information:
Title
Resolution of clinical signs of blepharitis
Time Frame
Day 28
Secondary Outcome Measure Information:
Title
Time to first clinical resolution
Time Frame
Days 7, 14, 21, 28, 42, 56, 70, and 84
Title
Mean and change from baseline for clinical signs of blepharitis
Time Frame
Days 7, 14, 21, 28, 42, 56, 70, and 84
Title
Mean and change from end of dosing for clinical signs of blepharitis
Time Frame
Days 42, 56, 70, and 84
Title
Response to the Blepharitis Symptoms Questionnaire (BSQ)
Time Frame
Days 1, 7, 14, 21, 28, 42, 56, 70, and 84
10. Eligibility
Sex
All
Minimum Age & Unit of Time
14 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Charles Johnson, MBChB
Organizational Affiliation
Chief Medical Officer
Official's Role
Study Chair
12. IPD Sharing Statement
Learn more about this trial
A Four Week Study of Azithromycin Ophthalmic Solution, 1% Versus Vehicle in Subjects With Blepharitis (P08636)
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