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

This study has been completed.
Sponsor:
Collaborator:
Allergan
Information provided by (Responsible Party):
William Ridder, Southern California College of Optometry
ClinicalTrials.gov Identifier:
NCT01013077
First received: November 11, 2009
Last updated: June 29, 2012
Last verified: June 2012
  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.

Resource links provided by NLM:


Further study details as provided by Southern California College of Optometry:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01013077

Locations
United States, California
Southern California College of Optometry
Fullerton, California, United States, 92831
Sponsors and Collaborators
Southern California College of Optometry
Allergan
Investigators
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 July 24, 2014