Tears Substitutions and Their Effects on Higher Order Aberrometery

Dry Eye Syndrome Clinical Trial

Official title:

Tears Substitutions and Their Effects on Higher Order Aberrometery

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00812721
• Other study ID #: Iowa RR 01
• Status: Withdrawn
• Phase: N/A
• First received: December 18, 2008
• Last updated: March 30, 2017
• Start date: January 2009
• Est. completion date: July 2009

Study information

• Verified date: March 2017
• Source: University of Iowa
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: July 2009
• Est. primary completion date: June 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

• Dry Eye Syndrome
• Dry Eye Syndromes
• Keratoconjunctivitis Sicca

Intervention

Other:
• Preservative Free Saline
One drop will be instilled into each eye once
• Optive
One drop will be instilled into each eye once
• Refresh Moderate/Severe
One drop will be instilled into each eye once
• Systane
One drop will be instilled into each eye once
• Systane Ultra
One drop will be instilled into each eye once

Locations

Country	Name	City	State
United States	University of Iowa Department of Ophthalmology and Visual Sciences	Iowa City	Iowa

Sponsors (1)

Lead Sponsor	Collaborator
Gina Rogers

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Measurement of a subject's higher order aberrations over time is the primary outcome measure		pre drop instillation, 1, 5, 15, 30, and 60 minutes post instillation

External Links

•   Ocular Surface Disease Index Questionnaire (part of eleigibility determination)