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

Dry Eye Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01013077
• Other study ID #: 09-11
• Status: Completed
• Phase: N/A
• First received: November 11, 2009
• Last updated: June 29, 2012
• Start date: November 2009
• Est. completion date: August 2011

Study information

• Verified date: June 2012
• Source: Southern California College of Optometry
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: August 2011
• Est. primary completion date: March 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Dry Eye Syndrome
• Dry Eye Syndromes
• Hypersensitivity
• Keratoconjunctivitis Sicca

Intervention

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

Locations

Country	Name	City	State
United States	Southern California College of Optometry	Fullerton	California

Sponsors (2)

Lead Sponsor	Collaborator
Southern California College of Optometry	Allergan

Country where clinical trial is conducted

United States, 

References & Publications (3)

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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	contrast sensitivity		Baseline, 1 week, 2 weeks, 4 weeks
Primary	aberrometry		baseline, 1 week, 2 weeks, 4 weeks
Primary	reading ability		baseline, week 4
Secondary	dry eye questionnaire		baseline, week 1, week 2, week 4
Secondary	slit lamp exam		baseline, week 4