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)
2 other identifiers
interventional
50
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started Mar 2010
Shorter than P25 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2010
CompletedFirst Submitted
Initial submission to the registry
April 15, 2010
CompletedFirst Posted
Study publicly available on registry
April 16, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2010
CompletedSeptember 26, 2011
September 1, 2011
8 months
April 15, 2010
September 20, 2011
Conditions
Outcome Measures
Primary Outcomes (1)
Subject-reported comfortable contact lens daily wear time (hours/day) at Week 4 Endpoint
4 weeks
Secondary Outcomes (6)
Subject-reported comfortable contact lens daily wear time, excluding Week 4 Endpoint
2 weeks
Subject-reported duration of total contact lens daily wear
4 weeks
Subject-reported rating of overall eye dryness
4 weeks
Contact Lens-Related Dry Eye Questionnaire
4 weeks
Tear hyperosmolarity (mOsm)
4 weeks
- +1 more secondary outcomes
Study Arms (2)
azithromycin ophthalmic solution, 1%
EXPERIMENTALrewetting drops
EXPERIMENTALInterventions
1 drop BID for the first 2 days and then 1 drop QD for the remainder of treatment period (29 ± 1 day)
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
The Ohio State University, College of Optometry
Columbus, Ohio, 43210, United States
Related Publications (1)
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.
PMID: 22157392DERIVED
MeSH Terms
Interventions
Study Officials
- STUDY CHAIR
Reza Haque, MD, PhD
Medical Monitor
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
April 15, 2010
First Posted
April 16, 2010
Study Start
March 1, 2010
Primary Completion
November 1, 2010
Study Completion
November 1, 2010
Last Updated
September 26, 2011
Record last verified: 2011-09