The Effect of a New Emulsion in Dry Eye Patients on Tear Layer Aberrometry, Contrast Sensitivity, and Reading Ability

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 Overview

• Status: Completed
• Conditions: Dry Eye Syndrome
• Intervention / Treatment: Other: Optive, Soothe, New Emulsion; Other: Soothe, New Emulsion, Optive; Other: New Emulsion, Optive, Soothe

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.

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Fullerton, California, United States, 92831
      • Southern California College of Optometry

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Non-Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Optive, Soothe, New Emulsion; Subjects do not use artificial tears for one week followed by 1 month using Optive two times per day. One week washout then 1 month Soothe two times per day followed by one week washout and one month New Emulsion 2 times per day.	Other: Optive, Soothe, New Emulsion; One week without artificial tear use followed by Optive use a minimum of 2 drops per day for 1 month. One week without artificial tear use followed by Soothe use a minimum of 2 drops per day for 1 month. One week without artificial tear use followed by the New Emulsion use a minimum of 2 drops per day for 1 month.
Experimental: Soothe, New Emulsion, Optive; Subjects do not use artificial tears for one week followed by 1 month using Soothe two times per day. One week washout then 1 month New Emulsion two times per day followed by one week washout and one month Optive 2 times per day.	Other: Soothe, New Emulsion, Optive; One week without artificial tear use followed by Soothe use a minimum of 2 drops per day for 1 month. One week without artificial tear use followed by New Emulsion use a minimum of 2 drops per day for 1 month. One week without artificial tear use followed by the Optive use a minimum of 2 drops per day for 1 month.
Experimental: New Emulsion, Optive, Soothe; Subjects do not use artificial tears for one week followed by 1 month using New Emulsion two times per day. One week washout then 1 month Optive two times per day followed by one week washout and one month Soothe 2 times per day.	Other: New Emulsion, Optive, Soothe; One week without artificial tear use followed by New Emulsion use a minimum of 2 drops per day for 1 month. One week without artificial tear use followed by Optive use a minimum of 2 drops per day for 1 month. One week without artificial tear use followed by the Soothe use a minimum of 2 drops per day for 1 month.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Contrast Sensitivity	Change in contrast sensitivity with administration of the artificial tear. During a visit, contrast sensitivity is initially monitored for several minutes (i.e., pre-artificial tear application contrast sensitivity) and the artificial tear is then applied and the contrast sensitivity is continually measured for several more minutes (post-artificial tear application contrast sensitivity). The administration of the artificial tear decreases contrast sensitivity for approximately a minute. The data reported in the table is the change in contrast sensitivity from pre-artificial tear administration to the peak loss in contrast sensitivity after the artificial tear administration (negative values). This procedure is carried out before the subjects use artificial tears on a daily basis (i.e., baseline data) and for several weeks after using artificial tears on a daily basis (i.e., weeks 1, 2, and 4) to determine if there is an adaptation to the artificial tear.	Baseline, 1 week, 2 weeks, 4 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
dry eye questionnaire	baseline, week 1, week 2, week 4
slit lamp exam	baseline, week 4

Collaborators and Investigators

• Sponsor: Southern California College of Optometry at Marshall B. Ketchum University
• Collaborators: Allergan
• Investigators: Principal Investigator: William H. Ridder, OD, PhD, Southern California College of Optometry at Marshall B. Ketchum University

Publications and helpful links

General Publications

• 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.
• 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.
• 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):370-377. doi: 10.1097/01.OPX.0000162646.30666.E3.

Study record dates

Study Major Dates

• Study Start: November 1, 2009
• Primary Completion (Actual): March 1, 2011
• Study Completion (Actual): August 1, 2011

Study Registration Dates

• First Submitted: November 11, 2009
• First Submitted That Met QC Criteria: November 12, 2009
• First Posted (Estimated): November 13, 2009

Study Record Updates

• Last Update Posted (Actual): June 12, 2025
• Last Update Submitted That Met QC Criteria: June 11, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Keywords: reading ability; contrast sensitivity; aberrometry; functional vision
• Additional Relevant MeSH Terms: Immune System Diseases; Eye Diseases; Corneal Diseases; Lacrimal Apparatus Diseases; Keratoconjunctivitis; Conjunctivitis; Conjunctival Diseases; Keratitis; Hypersensitivity; Dry Eye Syndromes; Keratoconjunctivitis Sicca
• Other Study ID Numbers: 09-11

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: All data is available upon request.