NCT01014780

Completed

Tear Film Thickness Measured Using a Novel Technique

Southern California College of Optometry at Marshall B. Ketchum University Source

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Other study identifiers

Sponsor study identifier

09-10

Study Type

observational

Estimated enrollment

40

Locations

1 country

Sites

1

Timeline

Study Start

November 2009

Date type not reported

This date has not been verified as actual or estimated.

Primary Completion

April 2010

Actual (reported)

Study Completion

October 2010

Actual (reported)

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.

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: completed
Estimated enrollment: 40 participants
Study completion date: October 2010
Actual (reported)
Listed locations: 1 countries · 1 sites

Trial Relationships

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Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

Study Start
November 2009
Date type not reported
This date has not been verified as actual or estimated.
First Submitted
November 16, 2009
Actual (reported)
First Posted
November 17, 2009
Actual (reported)
Primary Completion
April 2010
Actual (reported)
Study Completion
October 2010
Actual (reported)

Last Updated: October 11, 2010
Status Verified: September 2010
Last Update Submitted: October 8, 2010

Conditions

Dry Eye

Keywords

dry eyetear filmthicknessartificial 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

Age18 Years+

Sexall

Healthy VolunteersYes

Age GroupsAdult (18-64), Older Adult (65+)

Sampling MethodNon-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.

Sponsors & Collaborators

Southern California College of Optometry at Marshall B. Ketchum University
Otherlead

Study Sites (1)

Southern California College of Optometry

Fullerton, California, 92831', United States

MeSH Terms

Conditions

Dry Eye Syndromes

Condition Hierarchy (Ancestors)

Lacrimal Apparatus DiseasesEye 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 2009

Date type not reported

This date has not been verified as actual or estimated.

Primary Completion

April 2010

Actual (reported)

NCT00706940

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Completed

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Tear Osmolarity Changes After Instilling Isotonic Hyaluronate Artificial Tears

Phase 4Completed

NCT01227226

Tear Osmolarity Over Time With Artificial Tears

Phase 4Unknown

NCT00622037

Bilateral, Masked Comparison of PEG-400 Based Artificial Tear and Systane for the Treatment of Dry Eye Signs, Symptoms and Visual Quality

Phase 4Completed

NCT00833235

A Natural History Study of Patients With Dry Eye

Completed

NCT01061268

A Clinical Evaluation Pilot Study of the Efficacy of Blink® Tears Lubricant Eye Drops for the Relief of Dry Eye Symptoms Following Implantation of Tecnis® Multifocal Introcular Lens

Phase 4Completed

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.

+6 more criteria

Contact the study team to confirm eligibility.

Study Completion

October 2010

Actual (reported)

Last Updated

October 11, 2010

Record last verified: 2010-09

Source record

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Source: ClinicalTrials.gov.

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Registry identifier: NCT01014780
Data provider: ClinicalTrials.gov
Source updated: 2010-10-11
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:36:35 UTC

Locations

US(1)

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (1)

Study Arms (2)

Normal (non-dry) dry eye subjects

Dry eye subjects

Eligibility Criteria

You may not qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Study Design

Study Record Dates

Source record

Locations