Tears Substitutions and Their Effects on Higher Order Aberrometery - Full Text View

Sponsored by:	University of Iowa
Information provided by:	University of Iowa
ClinicalTrials.gov Identifier:	NCT00812721

Purpose

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.

Condition	Intervention
Dry Eye Syndrome	Other: Preservative Free Saline Other: Optive Other: Refresh Moderate/Severe Other: Systane Other: Systane Ultra

Drug Information available for: Sodium chloride

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Supportive Care, Single Blind (Subject), Placebo Control, Parallel Assignment, Efficacy Study
Official Title:	Tears Substitutions and Their Effects on Higher Order Aberrometery

Further study details as provided by University of Iowa:

Primary Outcome Measures:

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 ] [ Designated as safety issue: No ]

Estimated Enrollment:	50
Study Start Date:	January 2009
Estimated Study Completion Date:	July 2009
Estimated Primary Completion Date:	June 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Placebo Comparator Preservative Free Saline	Other: Preservative Free Saline One drop will be instilled into each eye once
2: Active Comparator Optive (TM)	Other: Optive One drop will be instilled into each eye once
3: Active Comparator Refresh Moderate/Severe (TM)	Other: Refresh Moderate/Severe One drop will be instilled into each eye once
4: Active Comparator Systane (TM)	Other: Systane One drop will be instilled into each eye once
5: Active Comparator Systane Ultra (TM)	Other: Systane Ultra One drop will be instilled into each eye once

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.

Eligibility

Ages Eligible for Study:	18 Years to 85 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00812721

Contacts

Contact: Gina M Rogers, MD	773 580 0339	gina-rogers@uiowa.edu
Contact: Christine Sindt, OD	(319) 356-4816	christine-sindt@uiowa.edu

Locations

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

Sponsors and Collaborators

University of Iowa

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

More Information

Ocular Surface Disease Index Questionnaire (part of eleigibility determination) This link exits the ClinicalTrials.gov site

Responsible Party:	University of Iowa Department of Ophthalmology and Visual Sciences ( Gina M Rogers, MD )
Study ID Numbers:	Iowa RR 01
Study First Received:	December 18, 2008
Last Updated:	December 19, 2008
ClinicalTrials.gov Identifier:	NCT00812721
Health Authority:	United States: Institutional Review Board

Keywords provided by University of Iowa:

higher order aberrations
tear blur

Study placed in the following topic categories:

Lacerations
Eye Diseases
Lacrimal Apparatus Diseases
Dry Eye Syndromes

Additional relevant MeSH terms:

Pathologic Processes
Disease
Syndrome

ClinicalTrials.gov processed this record on January 13, 2009