- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01105624
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)
September 20, 2011 updated by: Merck Sharp & Dohme LLC
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
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
50
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Ohio
-
Columbus, Ohio, United States, 43210
- The Ohio State University, College of Optometry
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
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 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 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)
|
Experimental: rewetting drops
|
1-2 drops QID for the treatment period (29 ± 1 day)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Subject-reported comfortable contact lens daily wear time (hours/day) at Week 4 Endpoint
Time Frame: 4 weeks
|
4 weeks
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Subject-reported comfortable contact lens daily wear time, excluding Week 4 Endpoint
Time Frame: 2 weeks
|
2 weeks
|
Subject-reported duration of total contact lens daily wear
Time Frame: 4 weeks
|
4 weeks
|
Subject-reported rating of overall eye dryness
Time Frame: 4 weeks
|
4 weeks
|
Contact Lens-Related Dry Eye Questionnaire
Time Frame: 4 weeks
|
4 weeks
|
Tear hyperosmolarity (mOsm)
Time Frame: 4 weeks
|
4 weeks
|
Habitual low-contrast visual acuity (LCVA)
Time Frame: 4 weeks
|
4 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2010
Primary Completion (Actual)
November 1, 2010
Study Completion (Actual)
November 1, 2010
Study Registration Dates
First Submitted
April 15, 2010
First Submitted That Met QC Criteria
April 15, 2010
First Posted (Estimate)
April 16, 2010
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
Other Study ID Numbers
- 041-117
- P08644
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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