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

NCT01013077 | Completed Results

• 1 other identifier: 09-11
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Dry Eye Syndrome

Keywords

functional vision; contrast sensitivity; aberrometry; reading ability

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (3)

Optive, Soothe, New Emulsion

EXPERIMENTAL

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

Soothe, New Emulsion, Optive

EXPERIMENTAL

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

New Emulsion, Optive, Soothe

EXPERIMENTAL

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

Interventions

Optive, Soothe, New Emulsion 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.

Optive, Soothe, New Emulsion

Soothe, New Emulsion, Optive 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.

Soothe, New Emulsion, Optive

New Emulsion, Optive, Soothe 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.

New Emulsion, Optive, Soothe

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• mild, moderate, or severe symptoms of dry eye

You may not qualify if:

• uncontrolled systemic disease
• contact lens wear
• participation in another clinical trial
• best corrected visual acuity poorer than 20/25

Sponsors & Collaborators

• Southern California College of Optometry at Marshall B. Ketchum University: lead
• Allergan: collaborator

Study Sites (1)

Southern California College of Optometry

Fullerton, California, 92831, United States

Location

Related Publications (3)

• 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.

  PMID: 12086305 BACKGROUND

• 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.

  PMID: 15894913 BACKGROUND

• 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.

  PMID: 19648840 BACKGROUND

MeSH Terms

Conditions

Dry Eye Syndromes

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases

Results Point of Contact

• Title: William Ridder
• Organization: Southern California College of Optometry

wridder@scco.edu

714-449-7494

Study Officials

• William H. Ridder, OD, PhD

  Southern California College of Optometry at Marshall B. Ketchum University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: November 11, 2009
• First Posted: November 13, 2009
• Study Start: November 1, 2009
• Primary Completion: March 1, 2011
• Study Completion: August 1, 2011
• Last Updated: June 12, 2025
• Results First Posted: June 12, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)