The Effect of a New Emulsion in Dry Eye Patients on Tear Layer Aberrometry, Contrast Sensitivity, and Reading Ability
Primary Purpose
Dry Eye Syndrome
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Optive
Soothe
New Emulsion
Sponsored by
About this trial
This is an interventional basic science trial for Dry Eye Syndrome focused on measuring functional vision, contrast sensitivity, aberrometry, reading ability
Eligibility Criteria
Inclusion Criteria:
- mild, moderate, or severe symptoms of dry eye
Exclusion Criteria:
- uncontrolled systemic disease
- contact lens wear
- participation in another clinical trial
- best corrected visual acuity poorer than 20/25
Sites / Locations
- Southern California College of Optometry
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
Optive
Soothe
New Emulsion
Arm Description
Commercial drop.
Commercial drop.
New formulation.
Outcomes
Primary Outcome Measures
contrast sensitivity
aberrometry
reading ability
Secondary Outcome Measures
dry eye questionnaire
slit lamp exam
Full Information
NCT ID
NCT01013077
First Posted
November 11, 2009
Last Updated
June 29, 2012
Sponsor
Southern California College of Optometry at Marshall B. Ketchum University
Collaborators
Allergan
1. Study Identification
Unique Protocol Identification Number
NCT01013077
Brief Title
The Effect of a New Emulsion in Dry Eye Patients on Tear Layer Aberrometry, Contrast Sensitivity, and Reading Ability
Official Title
The Effect of a New Emulsion in Dry Eye Patients on Tear Layer Aberrometry, Contrast Sensitivity, and Reading Ability.
Study Type
Interventional
2. Study Status
Record Verification Date
June 2012
Overall Recruitment Status
Completed
Study Start Date
November 2009 (undefined)
Primary Completion Date
March 2011 (Actual)
Study Completion Date
August 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Southern California College of Optometry at Marshall B. Ketchum University
Collaborators
Allergan
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to investigate how the addition of a new emulsion artificial tear to the tear layer of dry eye and normal patients affects aberrometry, contrast sensitivity, and reading ability over time. Previous studies have indicated that daily use of artificial tears over a two week period decreases the short term affect of drop application on aberrometry and contrast sensitivity measurements. The present study will examine the effects of 4 weeks of artificial tear use to determine when the responses stabilize.
Detailed Description
Dry eye patients experience symptoms such as; irritation, dryness, a scratchy sensation, and blur. These symptoms are the result of an insufficient tear layer. Blur can occur in dry eye patients because of an irregular tear film surface.
Artificial tears are applied to the eye to treat a variety of eye conditions. These conditions typically are associated with dry eyes and include tear film deficiency due to ocular or systemic disease, lid resurfacing problems, and contact lens wear. The artificial tears are used to alleviate the dry eye symptoms.
Dry eye is a frequently encountered ocular condition. Recent studies estimate that 7.8% of women and 4.8% of men over the age of 50 suffer from dry eye. The administration of an artificial tear to the eye can disrupt the tear layer and this disruption could then result in a change in contrast sensitivity for a few moments. Aberrometry is a technique that is able to monitor tear layer disruption and its results may correlate with contrast sensitivity changes.
Tear layer disruption results in a decrease in the modulation transfer function (MTF) for the eye. Since the tear layer is the first refracting surface of the eye, its disruption can also result in a change in contrast sensitivity, visual acuity, and aberrometry. Previous work has demonstrated that higher order aberrations increase 1.44 fold after the tear film breaks up in normal subjects. Dry eye subjects demonstrate a significant increase in higher order aberrations (i.e., total S3+4+5, spherical-like S4, and coma-like S3+5) when compared to normal subjects. This has been interpreted to be the result of increased tear irregularities in the dry eye subjects.
When an artificial tear (i.e., Vismed) was applied to the tear layer of dry eye subjects, the optical aberrations decreased. This previous study only examined the short term affect (less than 10 minutes) of a single administration of an artificial tear. In this study, we propose to examine the short and long term effects of a new emulsion on contrast sensitivity, optical aberrations, and reading ability after administration into the tear layer of normal and dry eye subjects.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dry Eye Syndrome
Keywords
functional vision, contrast sensitivity, aberrometry, reading ability
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Non-Randomized
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Optive
Arm Type
Experimental
Arm Description
Commercial drop.
Arm Title
Soothe
Arm Type
Experimental
Arm Description
Commercial drop.
Arm Title
New Emulsion
Arm Type
Experimental
Arm Description
New formulation.
Intervention Type
Drug
Intervention Name(s)
Optive
Intervention Description
Use a minimum of 2 drops per day for 1 month.
Intervention Type
Drug
Intervention Name(s)
Soothe
Intervention Description
Use a minimum of 2 drops per day for 1 month.
Intervention Type
Drug
Intervention Name(s)
New Emulsion
Intervention Description
Use a minimum of 2 drops per day for 1 month.
Primary Outcome Measure Information:
Title
contrast sensitivity
Time Frame
Baseline, 1 week, 2 weeks, 4 weeks
Title
aberrometry
Time Frame
baseline, 1 week, 2 weeks, 4 weeks
Title
reading ability
Time Frame
baseline, week 4
Secondary Outcome Measure Information:
Title
dry eye questionnaire
Time Frame
baseline, week 1, week 2, week 4
Title
slit lamp exam
Time Frame
baseline, week 4
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
mild, moderate, or severe symptoms of dry eye
Exclusion Criteria:
uncontrolled systemic disease
contact lens wear
participation in another clinical trial
best corrected visual acuity poorer than 20/25
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
William H. Ridder, OD, PhD
Organizational Affiliation
Southern California College of Optometry at Marshall B. Ketchum University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Southern California College of Optometry
City
Fullerton
State/Province
California
ZIP/Postal Code
92831
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
12086305
Citation
Thai LC, Tomlinson A, Ridder WH. Contact lens drying and visual performance: the vision cycle with contact lenses. Optom Vis Sci. 2002 Jun;79(6):381-8. doi: 10.1097/00006324-200206000-00012.
Results Reference
background
PubMed Identifier
15894913
Citation
Ridder WH 3rd, Lamotte JO, Ngo L, Fermin J. Short-term effects of artificial tears on visual performance in normal subjects. Optom Vis Sci. 2005 May;82(5):370-7. doi: 10.1097/01.opx.0000162646.30666.e3.
Results Reference
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PubMed Identifier
19648840
Citation
Ridder WH 3rd, LaMotte J, Hall JQ Jr, Sinn R, Nguyen AL, Abufarie L. Contrast sensitivity and tear layer aberrometry in dry eye patients. Optom Vis Sci. 2009 Sep;86(9):E1059-68. doi: 10.1097/OPX.0b013e3181b599bf.
Results Reference
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The Effect of a New Emulsion in Dry Eye Patients on Tear Layer Aberrometry, Contrast Sensitivity, and Reading Ability
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