The Effect of a New Emulsion in Dry Eye Patients on Tear Layer Aberrometry, Contrast Sensitivity, and Reading Ability
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Dry Eye Syndrome |
Drug: Optive Drug: Soothe Drug: New Emulsion |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Intervention Model: Crossover Assignment Masking: Single Blind (Subject) Primary Purpose: Basic Science |
| Official Title: | The Effect of a New Emulsion in Dry Eye Patients on Tear Layer Aberrometry, Contrast Sensitivity, and Reading Ability. |
- contrast sensitivity [ Time Frame: Baseline, 1 week, 2 weeks, 4 weeks ] [ Designated as safety issue: No ]
- aberrometry [ Time Frame: baseline, 1 week, 2 weeks, 4 weeks ] [ Designated as safety issue: No ]
- reading ability [ Time Frame: baseline, week 4 ] [ Designated as safety issue: No ]
- dry eye questionnaire [ Time Frame: baseline, week 1, week 2, week 4 ] [ Designated as safety issue: No ]
- slit lamp exam [ Time Frame: baseline, week 4 ] [ Designated as safety issue: No ]
| Enrollment: | 20 |
| Study Start Date: | November 2009 |
| Study Completion Date: | August 2011 |
| Primary Completion Date: | March 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Optive
Commercial drop.
|
Drug: Optive
Use a minimum of 2 drops per day for 1 month.
|
|
Experimental: Soothe
Commercial drop.
|
Drug: Soothe
Use a minimum of 2 drops per day for 1 month.
|
|
Experimental: New Emulsion
New formulation.
|
Drug: New Emulsion
Use a minimum of 2 drops per day for 1 month.
|
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
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
Contacts and Locations| United States, California | |
| Southern California College of Optometry | |
| Fullerton, California, United States, 92831 | |
| Principal Investigator: | William H. Ridder, OD, PhD | Southern California College of Optometry |
More Information
Publications:
| Responsible Party: | William Ridder, Professor, Southern California College of Optometry |
| ClinicalTrials.gov Identifier: | NCT01013077 History of Changes |
| Other Study ID Numbers: | 09-11 |
| Study First Received: | November 11, 2009 |
| Last Updated: | June 29, 2012 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Southern California College of Optometry:
|
functional vision contrast sensitivity aberrometry reading ability |
Additional relevant MeSH terms:
|
Dry Eye Syndromes Keratoconjunctivitis Sicca Lacrimal Apparatus Diseases Eye Diseases Keratoconjunctivitis |
Conjunctivitis Conjunctival Diseases Keratitis Corneal Diseases |
ClinicalTrials.gov processed this record on May 19, 2013