Back to resultsEvaluation of an Investigational Lubricant Eye Drop on Lipid Layer Thickness
Primary Purpose
Dry Eye
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
ORB Ocular Emulsion
SootheXP Emollient (Lubricant) Eye Drops
Sponsored by
About this trial
This is an interventional treatment trial for Dry Eye focused on measuring lipid layer thickness
Eligibility Criteria
Inclusion Criteria:
- Patients (minimum age 18) meeting specific criteria for dry eye.
Exclusion Criteria:
- Use of topical ocular drops within 12 hours of the study visit; or use of topical ocular ointment within 36 hours of the study visit. In addition, cannot use any topical ocular drugs during study period.
- History or evidence of ocular or systemic medical conditions and/or medications that would confound the evaluation.
Sites / Locations
- Alcon Call Center for Trial Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
Right Eye
Left Eye
Arm Description
ORB Ocular Emulsion or SootheXP
ORB Ocular Emulsion or SootheXP
Outcomes
Primary Outcome Measures
Lipid layer thickness
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01066988
Brief Title
Evaluation of an Investigational Lubricant Eye Drop on Lipid Layer Thickness
Study Type
Interventional
2. Study Status
Record Verification Date
February 2012
Overall Recruitment Status
Completed
Study Start Date
January 2010 (undefined)
Primary Completion Date
February 2010 (Actual)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Alcon Research
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to evaluate the effects of an investigational lubricant eye drop on tear film lipid layer thickness of dry eye patients.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dry Eye
Keywords
lipid layer thickness
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Right Eye
Arm Type
Other
Arm Description
ORB Ocular Emulsion or SootheXP
Arm Title
Left Eye
Arm Type
Other
Arm Description
ORB Ocular Emulsion or SootheXP
Intervention Type
Other
Intervention Name(s)
ORB Ocular Emulsion
Intervention Description
lubricant eye drop
Intervention Type
Other
Intervention Name(s)
SootheXP Emollient (Lubricant) Eye Drops
Intervention Description
lubricant eye drop
Primary Outcome Measure Information:
Title
Lipid layer thickness
Time Frame
Baseline through 120 minutes post instillation
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients (minimum age 18) meeting specific criteria for dry eye.
Exclusion Criteria:
Use of topical ocular drops within 12 hours of the study visit; or use of topical ocular ointment within 36 hours of the study visit. In addition, cannot use any topical ocular drugs during study period.
History or evidence of ocular or systemic medical conditions and/or medications that would confound the evaluation.
Facility Information:
Facility Name
Alcon Call Center for Trial Locations
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76134
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
21750611
Citation
Benelli U. Systane lubricant eye drops in the management of ocular dryness. Clin Ophthalmol. 2011;5:783-90. doi: 10.2147/OPTH.S13773. Epub 2011 Jun 10.
Results Reference
result
Learn more about this trial
Evaluation of an Investigational Lubricant Eye Drop on Lipid Layer Thickness
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