Tears Substitutions and Their Effects on Higher Order Aberrometery

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2008 by University of Iowa.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
University of Iowa
ClinicalTrials.gov Identifier:
NCT00812721
First received: December 18, 2008
Last updated: September 24, 2009
Last verified: December 2008
  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

Resource links provided by NLM:


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
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
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 Not yet recruiting
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

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 July 23, 2014