- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01139372
An Evaluation of the Daytime Use of an Investigational Lubricant Eye Drop
February 1, 2012 updated by: Alcon Research
The purpose of this study is to describe the subjective assessments of an investigational lubricant eye drop.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
96
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
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Documented diagnosis of dry eye
- Current use of Refresh Liquigel, GenTeal Gel Drops or Refresh Celluvisc at least twice daily
Exclusion Criteria:
- Must not have worn contact lenses within 7 days preceding enrollment
- Must not have had punctal plugs inserted within 30 days preceding enrollment
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: NON_RANDOMIZED
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: FID 115958D
Lubricant eye drop
|
1 drop in each eye at least twice daily
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Daytime Use Assessment: "I would use this product at bedtime for my dry eye symptoms" Likert scale (i.e. strongly disagree, disagree, neither disagree nor agree, agree, strongly agree)
Time Frame: Day 7
|
Day 7
|
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
May 1, 2010
Primary Completion (ACTUAL)
June 1, 2010
Study Completion (ACTUAL)
June 1, 2010
Study Registration Dates
First Submitted
June 7, 2010
First Submitted That Met QC Criteria
June 7, 2010
First Posted (ESTIMATE)
June 8, 2010
Study Record Updates
Last Update Posted (ESTIMATE)
February 2, 2012
Last Update Submitted That Met QC Criteria
February 1, 2012
Last Verified
February 1, 2012
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- C-10-006
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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