- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00812721
Tears Substitutions and Their Effects on Higher Order Aberrometery
Study Overview
Status
Conditions
Intervention / Treatment
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
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Iowa
-
Iowa City, Iowa, United States, 52242
- University of Iowa Department of Ophthalmology and Visual Sciences
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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
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
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
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.
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