- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00673959
Acute Comfort of Lubricant Eye Drop FID 111421
January 31, 2012 updated by: Alcon Research
To evaluate the acute comfort and blurring profile between two artificial tears products in dry eye patients
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
20
Phase
- Not Applicable
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
16 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Documented diagnosis of dry eye
- Must not have worn contact lenses for 1 week preceding enrollment
Exclusion Criteria:
- Age related
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: Crossover Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Lubricant Eye Drop FID 111421
Lubricant Eye Drop FID 111421 1 drop each eye one time
|
Lubricant Eye Drop FID 111421 1 drop each eye one time
|
Active Comparator: Optive Lubricant Eye Drop
Optive Lubricant Eye Drop 1 drop each eye one time
|
Optive Lubricant Eye Drop 1 drop each eye one time
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Drop Comfort Upon Instillation
Time Frame: upon instillation
|
Drop comfort grading scale is a scale from 0 to 9, with 0 meaning most comfortable and 9 meaning most uncomfortable.
|
upon instillation
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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
December 1, 2007
Primary Completion (Actual)
February 1, 2008
Study Registration Dates
First Submitted
May 2, 2008
First Submitted That Met QC Criteria
May 6, 2008
First Posted (Estimate)
May 7, 2008
Study Record Updates
Last Update Posted (Estimate)
February 2, 2012
Last Update Submitted That Met QC Criteria
January 31, 2012
Last Verified
January 1, 2012
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- C-07-08
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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