Tears Substitutions and Their Effects on Higher Order Aberrometery

March 30, 2017 updated by: Gina Rogers
Hypothesis is that tear substitutions cause blur after they are instilled. The investigators will use aberrometry as a measurement over time after a tear formulation is used and try to determine if there are any measurable change in higher order aberrations between different tear formulations and how long it takes to return to pre-instillation measurements thus providing information on duration of the tear drop. 4 commercially available "dry eye" artificial tears formulations will be used and preservative saline will act as a control. The study will be conducted on subjects that do not have clinical evidence of dry eye syndrome to focus the data on the blur effects of the tear substitutions.

Study Overview

Detailed Description

Once consent is obtained the subject will choose from available time slots. Each subject will come to the UIHC Department of Ophthalmology at designated times for approximately one hour on five different days, for a total time commitment of approximately 5 hours. Each subject will receive the same 4 artificial tear substitutes and saline, one different drop each day. One of the four tear substitutes (brands: Systane, Systane Ultra, Optive, and Refresh) will be tested on each of the days. One drop will be used each day and the protocol of each day will be the same, the only factor changing from day to day is the drop that is being evaluated. On each study day, the subject will have a pre-instillation measurement of their higher order aberrometry of each eye. One drop of the designated drop will be placed into each of the eyes. Subsequent aberrometry measurements of each eye will be taken at immediately post-instillation, 5 minutes, 30 minutes and 60 minutes post instillation. The same protocol will be followed with a saline drop and thus each patient will act as a control.

There is no long-term follow-up.

Study Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Iowa
      • Iowa City, Iowa, United States, 52242
        • University of Iowa Department of Ophthalmology and Visual Sciences

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Subjects that do not have any complaints of dry eye and confirmed by ocular surface disease index questionnaire.
  • Visually correctable to 20/20 in each eye.
  • Non contact lens wearer.
  • No history of systemic disease associated with dry eye syndromes.
  • No current use of ocular medications.
  • Adult volunteers who agree to HIPAA standards and sign informed consent.

Exclusion Criteria

  • Patients that have dry eye symptoms or slitlamp findings consistent with dry eye.
  • Have a systemic condition that is associated with dry eye syndromes.
  • Take systemic medications that have dry as a side effect
  • Currently use artificial tears.
  • Currently are using ocular medications.
  • Currently wear contact lenses.
  • Enrollment of the investigator's office staff, relatives, or members of their respective households.
  • Enrollment of more than one member of the same household.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: 1
Preservative Free Saline
One drop will be instilled into each eye once
Active Comparator: 2
Optive (TM)
One drop will be instilled into each eye once
Active Comparator: 3
Refresh Moderate/Severe (TM)
One drop will be instilled into each eye once
Active Comparator: 4
Systane (TM)
One drop will be instilled into each eye once
Active Comparator: 5
Systane Ultra (TM)
One drop will be instilled into each eye once

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Measurement of a subject's higher order aberrations over time is the primary outcome measure
Time Frame: pre drop instillation, 1, 5, 15, 30, and 60 minutes post instillation
pre drop instillation, 1, 5, 15, 30, and 60 minutes post instillation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Investigators

  • Principal Investigator: Gina M Rogers, MD, University of Iowa Department of Ophthalmology and Visual Sciences
  • Study Director: Christine Sindt, OD, niversity of Iowa Department of Ophthalmology and Visual Sciences

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2009

Primary Completion (Anticipated)

June 1, 2009

Study Completion (Anticipated)

July 1, 2009

Study Registration Dates

First Submitted

December 18, 2008

First Submitted That Met QC Criteria

December 19, 2008

First Posted (Estimate)

December 22, 2008

Study Record Updates

Last Update Posted (Actual)

April 4, 2017

Last Update Submitted That Met QC Criteria

March 30, 2017

Last Verified

March 1, 2017

More Information

Terms related to this study

Other Study ID Numbers

  • Iowa RR 01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Dry Eye Syndrome

Clinical Trials on Preservative Free Saline

Subscribe