Tears Substitutions and Their Effects on Higher Order Aberrometery

NCT00812721 | Withdrawn DMC

• 1 other identifier: Iowa RR 01
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Dry Eye Syndrome

Keywords

higher order aberrations; tear blur

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (5)

1

PLACEBO COMPARATOR

Preservative Free Saline

Other: Preservative Free Saline

2

ACTIVE COMPARATOR

Optive (TM)

Other: Optive

3

ACTIVE COMPARATOR

Refresh Moderate/Severe (TM)

Other: Refresh Moderate/Severe

4

ACTIVE COMPARATOR

Systane (TM)

Other: Systane

5

ACTIVE COMPARATOR

Systane Ultra (TM)

Other: Systane Ultra

Interventions

Preservative Free Saline OTHER

One drop will be instilled into each eye once

1

Optive OTHER

One drop will be instilled into each eye once

2

Refresh Moderate/Severe OTHER

One drop will be instilled into each eye once

3

Systane OTHER

One drop will be instilled into each eye once

4

Systane Ultra OTHER

One drop will be instilled into each eye once

5

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Gina Rogers: lead

Study Sites (1)

University of Iowa Department of Ophthalmology and Visual Sciences

Iowa City, Iowa, 52242, United States

Location

MeSH Terms

Conditions

Dry Eye Syndromes

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases

Study Officials

• Gina M Rogers, MD

  University of Iowa Department of Ophthalmology and Visual Sciences

  PRINCIPAL INVESTIGATOR

• Christine Sindt, OD

  niversity of Iowa Department of Ophthalmology and Visual Sciences

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 18, 2008
• First Posted: December 22, 2008
• Study Start: January 1, 2009
• Primary Completion: June 1, 2009
• Study Completion: July 1, 2009
• Last Updated: April 4, 2017

Record last verified: 2017-03

Locations

US (1)