Back to resultsA Four Week Study of Azithromycin Ophthalmic Solution, 1% Versus Rewetting Drops in Subjects With History and Current Complaint of Contact Lens-Related Dry Eye (CLDE)
Primary Purpose
Contact Lens Dry Eye
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
azithromycin ophthalmic solution, 1%
Visine® for Contacts®
Sponsored by
About this trial
This is an interventional treatment trial for Contact Lens Dry Eye
Eligibility Criteria
Inclusion Criteria:
- Have a history of and current complaint of CLDE.
- Use properly fitted daily-wear soft contact lenses.
- Able to wear contact lenses for at least 8 hours a day.
- If female, are non-pregnant or non-lactating.
Exclusion Criteria:
- Have changed brand of contact lens or care solutions within one month prior to Visit 1.
- Use extended (overnight) wear contact lenses.
- Have a clinically significant ophthalmic abnormality.
- 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 any active ongoing ocular infection or ocular disease.
- Have a serious medical condition which could confound study assessments.
Sites / Locations
- The Ohio State University, College of Optometry
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
azithromycin ophthalmic solution, 1%
rewetting drops
Arm Description
Outcomes
Primary Outcome Measures
Subject-reported comfortable contact lens daily wear time (hours/day) at Week 4 Endpoint
Secondary Outcome Measures
Subject-reported comfortable contact lens daily wear time, excluding Week 4 Endpoint
Subject-reported duration of total contact lens daily wear
Subject-reported rating of overall eye dryness
Contact Lens-Related Dry Eye Questionnaire
Tear hyperosmolarity (mOsm)
Habitual low-contrast visual acuity (LCVA)
Full Information
NCT ID
NCT01105624
First Posted
April 15, 2010
Last Updated
September 20, 2011
Sponsor
Merck Sharp & Dohme LLC
1. Study Identification
Unique Protocol Identification Number
NCT01105624
Brief Title
A Four Week Study of Azithromycin Ophthalmic Solution, 1% Versus Rewetting Drops in Subjects With History and Current Complaint of Contact Lens-Related Dry Eye (CLDE)
Study Type
Interventional
2. Study Status
Record Verification Date
September 2011
Overall Recruitment Status
Completed
Study Start Date
March 2010 (undefined)
Primary Completion Date
November 2010 (Actual)
Study Completion Date
November 2010 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Merck Sharp & Dohme LLC
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The primary objective of this study is to compare the duration of subject reported comfortable contact lens daily wear time in subjects with a history and current complaint of CLDE during a 29-day treatment period of azithromycin ophthalmic solution, 1%, compared to rewetting drops
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Contact Lens Dry Eye
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Arm Title
azithromycin ophthalmic solution, 1%
Arm Type
Experimental
Arm Title
rewetting drops
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
azithromycin ophthalmic solution, 1%
Intervention Description
1 drop BID for the first 2 days and then 1 drop QD for the remainder of treatment period (29 ± 1 day)
Intervention Type
Drug
Intervention Name(s)
Visine® for Contacts®
Intervention Description
1-2 drops QID for the treatment period (29 ± 1 day)
Primary Outcome Measure Information:
Title
Subject-reported comfortable contact lens daily wear time (hours/day) at Week 4 Endpoint
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Subject-reported comfortable contact lens daily wear time, excluding Week 4 Endpoint
Time Frame
2 weeks
Title
Subject-reported duration of total contact lens daily wear
Time Frame
4 weeks
Title
Subject-reported rating of overall eye dryness
Time Frame
4 weeks
Title
Contact Lens-Related Dry Eye Questionnaire
Time Frame
4 weeks
Title
Tear hyperosmolarity (mOsm)
Time Frame
4 weeks
Title
Habitual low-contrast visual acuity (LCVA)
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 history of and current complaint of CLDE.
Use properly fitted daily-wear soft contact lenses.
Able to wear contact lenses for at least 8 hours a day.
If female, are non-pregnant or non-lactating.
Exclusion Criteria:
Have changed brand of contact lens or care solutions within one month prior to Visit 1.
Use extended (overnight) wear contact lenses.
Have a clinically significant ophthalmic abnormality.
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 any active ongoing ocular infection or ocular disease.
Have a serious medical condition which could 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
The Ohio State University, College of Optometry
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
22157392
Citation
Nichols JJ, Bickle KM, Zink RC, Schiewe MD, Haque RM, Nichols KK. Safety and efficacy of topical azithromycin ophthalmic solution 1.0% in the treatment of contact lens-related dry eye. Eye Contact Lens. 2012 Mar;38(2):73-9. doi: 10.1097/ICL.0b013e31823ff229.
Results Reference
derived
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A Four Week Study of Azithromycin Ophthalmic Solution, 1% Versus Rewetting Drops in Subjects With History and Current Complaint of Contact Lens-Related Dry Eye (CLDE)
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