Safety Evaluation of a New Preservative in a Lubricating Eye Drop
Completed · Not applicable
Conditions studied: Dry Eye Syndromes
In brief
This study is to evaluate the safety of a new preservative in a lubricant eye drop used four times a day in healthy adults and subjects diagnosed with dry eye.
Key facts
- Study ID
- NCT01434277
- Run by
- Johnson & Johnson Consumer and Personal Products Worldwide
- People needed
- 44
- Starts
- 2011-04-01
- Expected to finish
- 2011-04-01
- Last updated by the study team
- 2011-09-14
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- At least 18 years of age
- Able to follow all study instructions and attend all required study visits
- Provide written informed consent
- Visual health and eye comfort within protocol-specified parameters
- Women of child-bearing potential must have a negative urine pregnancy test at screening, not be breast-feeding, and agree to use a protocol-specified acceptable form of birth control throughout the study
You may not qualify if…
- Any medical condition or history, or ocular scores, or use of any drug, device or medication that, per protocol or in the opinion of the investigator, might compromise the safety of the subject or analysis of the study results.
- Use of contact lenses outside protocol allowance
- Self-reported pregnancy, positive urine pregnancy test, breast-feeding; intends to become pregnant or breast-feed during the duration of the study, refuses protocol-specified urine pregnancy testing, and/or does not use protocol-specified birth control methods and agree to continue doing so for the duration of the study.
- Participated in an investigational drug or device trial within 30 days of entering the study.
Where it is running
- ORA, Inc. — Andover, Massachusetts, United States
Full record on ClinicalTrials.gov
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