Official Title: “The Effect of a New Emulsion in Dry Eye Patients on Tear Layer Aberrometry, Contrast Sensitivity, and Reading Ability.”

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.

Study Type: Interventional

Study Design: Basic Science, Non-Randomized, Single Blind (Subject), Crossover Assignment

Study Primary Completion Date: October 2011

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.

Intervention(s) in this Clinical Trial

• Drug: Optive
  • Use a minimum of 2 drops per day for 1 month.
• Drug: Soothe
  • Use a minimum of 2 drops per day for 1 month.
• Drug: New Emulsion
  • Use a minimum of 2 drops per day for 1 month.

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: Optive
  • Commercial drop.
• Experimental: Soothe
  • Commercial drop.
• Experimental: New Emulsion
  • New formulation.

Primary Measures

• contrast sensitivity
  • Time Frame: Baseline, 1 week, 2 weeks, 4 weeks
    Safety Issue?: No
• aberrometry
  • Time Frame: baseline, 1 week, 2 weeks, 4 weeks
    Safety Issue?: No
• reading ability
  • Time Frame: baseline, week 4
    Safety Issue?: No

Secondary Measures

• dry eye questionnaire
  • Time Frame: baseline, week 1, week 2, week 4
    Safety Issue?: No
• slit lamp exam
  • Time Frame: baseline, week 4
    Safety Issue?: No

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: Accepts Healthy Volunteers

Lead Sponsor: Southern California College of Optometry

Overall Clinical Trial Officials and Contacts

William H. Ridder, OD, PhD Principal Investigator Southern California College of Optometry  

Overall Contact: William H. Ridder, OD, PhD 714-449-7494 wridder@scco.edu

Information obtained from ClinicalTrials.gov on February 08, 2010

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT01013077

Study ID Number: 09-11

ClinicalTrials.gov Identifier: NCT01013077

Health Authority: United States: Institutional Review Board