The Ohio State University, College of Optometry
Columbus, Ohio, 43210, United States
Completed
NCT Number: 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)
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
Completed
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Notify MeKey information
Conditions
Age range
18 year and older
Sex eligibility
All sexes
Study type
Interventional
Phase
Phase 4
Primary location
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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.
Treatment and study plan
azithromycin ophthalmic solution, 1%
Drug1 drop BID for the first 2 days and then 1 drop QD for the remainder of treatment period (29 ± 1 day)
Visine® for Contacts®
Drug1-2 drops QID for the treatment period (29 ± 1 day)
Primary outcomes
-
Subject-reported comfortable contact lens daily wear time (hours/day) at Week 4 Endpoint
Time frame: 4 weeks
Secondary outcomes
-
Subject-reported comfortable contact lens daily wear time, excluding Week 4 Endpoint
Time frame: 2 weeks
-
Subject-reported duration of total contact lens daily wear
Time frame: 4 weeks
-
Subject-reported rating of overall eye dryness
Time frame: 4 weeks
-
Contact Lens-Related Dry Eye Questionnaire
Time frame: 4 weeks
-
Tear hyperosmolarity (mOsm)
Time frame: 4 weeks
-
Habitual low-contrast visual acuity (LCVA)
Time frame: 4 weeks
Sponsors and collaborators
Lead sponsor
Merck Sharp & Dohme LLC
Industry
Registry information
Important dates
- Study start
- 2010
- Primary completion
- 2010
- Study completion
- 2010
- First posted
- Apr 16, 2010
- Registry last updated
- Sep 26, 2011
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.