Tear Film Thickness Measured Using a Novel Technique

NCT01014780 | Completed

• 1 other identifier: 09-10
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this investigation is to determine the thickness of the human preocular tear film using a new method based on laser speckle. This will be a preliminary study to generate "normative" tear film thickness data in normal (i.e., non dry eye) and dry eye subjects in a clinic-based population. In addition, we will examine the short term (i.e., one week) repeatability of the method in a single setting. The patients classified as having dry eye will also have their tear film thickness measured after instillation of an artificial tear. This will potentially reveal valuable data in retention of effect measured non-invasively as in prior studies that employed a fluorescein tracer.

Conditions

Dry Eye

Keywords

dry eye; tear film; thickness; artificial tears

Outcome Measures

Primary Outcomes (1)

• Tear film thickness in normal eyes

  1-3 months

Secondary Outcomes (1)

• Tear thickness change following viscous drop instillation

  1-3 months

Study Arms (2)

Normal (non-dry) dry eye subjects

These are healthy individuals, age 18 and above, who do not exhibit dry eyes by signs and symptoms

Dry eye subjects

These are subjects, age 18 years and above, who do exhibit signs and symptoms of dry eye.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study will inculde up to 20 normals (i.e., non-dry eye) individuals, over the age of 18 years, adn 20 dry eye individuals.

You may not qualify if:

• The informed consent document must be read, signed and dated by the subject before conducting any procedures. Additionally, the informed consent document must be signed and dated by the individual obtaining consent of the subject. HIPAA authorization must also be signed and dated by the subject.
• Adult subjects, 18 years of age and older. Criteria for the mild to severe dry eye group must include two of the three following characteristics as demonstrated at the Eligibility visit:
• Composite symptom score of ≥ 7 on the Schein questionnaire:
• Sodium fluorescein (NaFl) tear break-up time ≤ 7 seconds in either (worse) eye
• Cumulative sodium fluorescein (NaFl) corneal staining ≥ 4 in either (worse) eye on a 0-20 point scale (corresponds to ≥ 3.0 on a 0-15 scale).
• Able and willing to follow study instructions.
• Willing to return for the repeatability visit within 7 plus or minus 2 days of the initial visit, and within the same one-half day (i.e., either in the morning or afternoon, similar to the first tear thickness visit).
• Subjects must have best corrected visual acuity of 20/25 or better in each eye as assessed using a standard Snellen acuity chart.
• Subjects wearing soft contacts lenses must be willing to discontinue wear for two days before each study visit.
• Subjects using any topical drops such as artificial tears must be willing to discontinue use of such drops for two days prior to all visits, including the baseline visit.
• Subjects demonstrating any medical condition that may affect the results of this study SHOULD NOT be enrolled. The following are specific conditions that exclude subjects from enrollment in this study:
• History or evidence of ocular or intraocular surgery in either eye within the past six months. LASIK and other kerato-refractive procedure patients can qualify if the most recent surgery or enhancement was 12 or more months prior.
• History or evidence of serious ocular trauma in either eye within the past six months.
• History of hypersensitivity to sodium fluorescein.
• History or evidence of epithelial herpes simplex keratitis (dendritic keratitis); vaccinia, active or recent varicella, viral disease of the cornea and/or conjunctiva; chronic bacterial disease of the cornea and/or conjunctiva; mycobacterial infection of the eye; and/or fungal disease of the eye.

Sponsors & Collaborators

• Southern California College of Optometry at Marshall B. Ketchum University: lead

Study Sites (1)

Southern California College of Optometry

Fullerton, California, 92831', United States

Location

MeSH Terms

Conditions

Dry Eye Syndromes

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases

Study Officials

• Jerry Paugh, OD. PhD

  Southern California College of Optometry at Marshall B. Ketchum University

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: November 16, 2009
• First Posted: November 17, 2009
• Study Start: November 1, 2009
• Primary Completion: April 1, 2010
• Study Completion: October 1, 2010
• Last Updated: October 11, 2010

Record last verified: 2010-09

Locations

US (1)