Tears Substitutions and Their Effects on Higher Order Aberrometery
Recruitment status was Not yet recruiting
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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 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Subject) Primary Purpose: Supportive Care |
| Official Title: | Tears Substitutions and Their Effects on Higher Order Aberrometery |
- 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 |
|---|---|
|
Placebo Comparator: 1
Preservative Free Saline
|
Other: Preservative Free Saline
One drop will be instilled into each eye once
|
|
Active Comparator: 2
Optive (TM)
|
Other: Optive
One drop will be instilled into each eye once
|
|
Active Comparator: 3
Refresh Moderate/Severe (TM)
|
Other: Refresh Moderate/Severe
One drop will be instilled into each eye once
|
|
Active Comparator: 4
Systane (TM)
|
Other: Systane
One drop will be instilled into each eye once
|
|
Active Comparator: 5
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 |
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| Contact: Gina M Rogers, MD | 773 580 0339 | gina-rogers@uiowa.edu |
| Contact: Christine Sindt, OD | (319) 356-4816 | christine-sindt@uiowa.edu |
| United States, Iowa | |
| University of Iowa Department of Ophthalmology and Visual Sciences | Not yet recruiting |
| Iowa City, Iowa, United States, 52242 | |
| 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
Additional Information:
No publications provided
| Responsible Party: | Gina M Rogers, MD, University of Iowa Department of Ophthalmology and Visual Sciences |
| ClinicalTrials.gov Identifier: | NCT00812721 History of Changes |
| Other Study ID Numbers: | Iowa RR 01 |
| Study First Received: | December 18, 2008 |
| Last Updated: | September 24, 2009 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by University of Iowa:
|
higher order aberrations tear blur |
Additional relevant MeSH terms:
|
Dry Eye Syndromes Keratoconjunctivitis Sicca Lacrimal Apparatus Diseases Eye Diseases Keratoconjunctivitis |
Conjunctivitis Conjunctival Diseases Keratitis Corneal Diseases |
ClinicalTrials.gov processed this record on May 19, 2013