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Tears Substitutions and Their Effects on Higher Order Aberrometery

Primary Purpose

Dry Eye Syndrome

Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Preservative Free Saline
Optive
Refresh Moderate/Severe
Systane
Systane Ultra
Sponsored by
Gina Rogers
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Dry Eye Syndrome focused on measuring higher order aberrations, tear blur

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • University of Iowa Department of Ophthalmology and Visual Sciences

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Placebo Comparator

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Arm Label

1

2

3

4

5

Arm Description

Preservative Free Saline

Optive (TM)

Refresh Moderate/Severe (TM)

Systane (TM)

Systane Ultra (TM)

Outcomes

Primary Outcome Measures

Measurement of a subject's higher order aberrations over time is the primary outcome measure

Secondary Outcome Measures

Full Information

First Posted
December 18, 2008
Last Updated
March 30, 2017
Sponsor
Gina Rogers
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1. Study Identification

Unique Protocol Identification Number
NCT00812721
Brief Title
Tears Substitutions and Their Effects on Higher Order Aberrometery
Official Title
Tears Substitutions and Their Effects on Higher Order Aberrometery
Study Type
Interventional

2. Study Status

Record Verification Date
March 2017
Overall Recruitment Status
Withdrawn
Why Stopped
PI left institution
Study Start Date
January 2009 (undefined)
Primary Completion Date
June 2009 (Anticipated)
Study Completion Date
July 2009 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Gina Rogers

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dry Eye Syndrome
Keywords
higher order aberrations, tear blur

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Non-Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Placebo Comparator
Arm Description
Preservative Free Saline
Arm Title
2
Arm Type
Active Comparator
Arm Description
Optive (TM)
Arm Title
3
Arm Type
Active Comparator
Arm Description
Refresh Moderate/Severe (TM)
Arm Title
4
Arm Type
Active Comparator
Arm Description
Systane (TM)
Arm Title
5
Arm Type
Active Comparator
Arm Description
Systane Ultra (TM)
Intervention Type
Other
Intervention Name(s)
Preservative Free Saline
Intervention Description
One drop will be instilled into each eye once
Intervention Type
Other
Intervention Name(s)
Optive
Intervention Description
One drop will be instilled into each eye once
Intervention Type
Other
Intervention Name(s)
Refresh Moderate/Severe
Intervention Description
One drop will be instilled into each eye once
Intervention Type
Other
Intervention Name(s)
Systane
Intervention Description
One drop will be instilled into each eye once
Intervention Type
Other
Intervention Name(s)
Systane Ultra
Intervention Description
One drop will be instilled into each eye once
Primary Outcome Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gina M Rogers, MD
Organizational Affiliation
University of Iowa Department of Ophthalmology and Visual Sciences
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Christine Sindt, OD
Organizational Affiliation
niversity of Iowa Department of Ophthalmology and Visual Sciences
Official's Role
Study Director
Facility Information:
Facility Name
University of Iowa Department of Ophthalmology and Visual Sciences
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242
Country
United States

12. IPD Sharing Statement

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Tears Substitutions and Their Effects on Higher Order Aberrometery

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