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

NCT ID: NCT01013077

Last Updated: 2025-06-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-11-30
• Study Completion Date: 2011-08-31

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.

Conditions

Dry Eye Syndrome

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Optive, Soothe, New Emulsion

Intervention Type: OTHER

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.

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.

Group Type: EXPERIMENTAL

Soothe, New Emulsion, Optive

Intervention Type: OTHER

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.

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.

Group Type: EXPERIMENTAL

New Emulsion, Optive, Soothe

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Allergan

INDUSTRY

Sponsor Role: collaborator

Southern California College of Optometry at Marshall B. Ketchum University

OTHER

Sponsor Role: lead

Responsible Party

William Ridder

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

William H. Ridder, OD, PhD

Role: PRINCIPAL_INVESTIGATOR

Southern California College of Optometry at Marshall B. Ketchum University

Locations

Southern California College of Optometry

Fullerton, California, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 12086305 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 15894913 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 19648840 (View on PubMed)

Other Identifiers

09-11

Identifier Type: -

Identifier Source: org_study_id