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)
NCT ID: NCT01105624
Last Updated: 2011-09-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
50 participants
INTERVENTIONAL
2010-03-31
2010-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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azithromycin ophthalmic solution, 1%
azithromycin ophthalmic solution, 1%
1 drop BID for the first 2 days and then 1 drop QD for the remainder of treatment period (29 ± 1 day)
rewetting drops
Visine® for Contacts®
1-2 drops QID for the treatment period (29 ± 1 day)
Interventions
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azithromycin ophthalmic solution, 1%
1 drop BID for the first 2 days and then 1 drop QD for the remainder of treatment period (29 ± 1 day)
Visine® for Contacts®
1-2 drops QID for the treatment period (29 ± 1 day)
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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Merck Sharp & Dohme LLC
INDUSTRY
Responsible Party
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Inspire
Principal Investigators
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Reza Haque, MD, PhD
Role: STUDY_CHAIR
Medical Monitor
Locations
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The Ohio State University, College of Optometry
Columbus, Ohio, United States
Countries
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References
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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.
Other Identifiers
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P08644
Identifier Type: -
Identifier Source: secondary_id
041-117
Identifier Type: -
Identifier Source: org_study_id