Dry EyeNCT01014780
Tear Film Thickness Measured Using a Novel Technique
An observational study of Dry Eye, run by Southern California College of Optometry at Marshall B. Ketchum University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Dry Eye
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2009to Oct 2010
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- There are no requirements as to subject race, gender or occupation. If the subjects have any questions or concerns regarding any of the inclusion or exclusion criteria, they will be encouraged to ask either investigator (Dr. Paugh or Dr. Kwan) for clarification. All subjects must meet the following criteria:
- 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).
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- 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.
Who cannot join
- 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.
- Patients requiring use of topical ocular medications such as glaucoma or allergy medications during the study period.
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- Individuals using systemic steroids, immunosuppressive agents and/or anti-cholinergics (e.g. cold and allergy medications, tricyclic antidepressants) for treatment of autoimmune connective tissue disease may not be enrolled in the study if they have not been on a stable dosing regimen for a minimum of 30 days prior to the first visit. In addition, the dosing regimen must remain stable throughout the study period, expected to be approximately one week.
- Individuals with diabetes.
- Ocular conditions such as conjunctival infections, or iritis.
- Individuals wearing rigid gas permeable contact lenses or using punctal plugs.
- Participation in an investigational drug or device study within 30 days of entering this study.
Trial locations and contacts
1 site in 1 country.
United States1 site
Southern California College of Optometry
Fullerton, California, 92831'
About this study
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.
Read the detailed description
We will generate "normative" tear thickness data in normal (i.e., not dry) and dry eyes in human subjects. We will examine short-term repeatability of the method, and we will examine the influence on tear thickness of a viscous eyedrop instilled into the eye.
- Conditions
- Dry Eye
- Keywords
- dry eye, tear film, thickness, artificial tears
- Medical subject headings
- Dry Eye Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tear film thickness in normal eyes
Measured: 1-3 months
Secondary outcomes (1)
Tear thickness change following viscous drop instillation
Measured: 1-3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2009 (estimated)
- Study startNov 2009
- Primary completionApr 2010
- Study completionOct 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dry EyeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Cross-sectional
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Southern California College of Optometry at Marshall B. Ketchum University
- Sponsor type
- University, hospital or other
- Investigators
- Jerry Paugh, OD. PhD, Study director, Southern California College of Optometry at Marshall B. Ketchum University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01014780
- Sponsor's protocol ID
- 09-10
- Status last verified
- Sep 2010
- First submitted
- 16 Nov 2009
- Last updated
- 11 Oct 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Oct 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tear Film Thickness Measured Using a Novel Technique
- ClinicalTrials.gov ID
- NCT01014780
- Acronym / sponsor ID
- 09-10
- Conditions
- Dry Eye
- Keywords
- dry eye, tear film, thickness, artificial tears
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Southern California College of Optometry at Marshall B. Ketchum UniversityUniversity, hospital or other
- Study start
- Nov 2009
- Primary completion
- Apr 2010 (actual)
- Study completion
- Oct 2010 (actual)
- First posted
- 17 Nov 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
We will generate "normative" tear thickness data in normal (i.e., not dry) and dry eyes in human subjects. We will examine short-term repeatability of the method, and we will examine the influence on tear thickness of a viscous eyedrop instilled into the eye.
Study design
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (11 listed)
- There are no requirements as to subject race, gender or occupation. If the subjects have any questions or concerns regarding any of the inclusion or exclusion criteria, they will be encouraged to ask either investigator (Dr. Paugh or Dr. Kwan) for clarification. All subjects must meet the following criteria:
- 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:
- 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).
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Tear film thickness in normal eyes
Time frame: 1-3 months
1 secondary outcome
Tear thickness change following viscous drop instillation
Time frame: 1-3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Oct 2010.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jerry Paugh, OD. PhD study director
Southern California College of Optometry at Marshall B. Ketchum University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Dry Eye, run by Southern California College of Optometry at Marshall B. Ketchum University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Oct 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tear film thickness in normal eyes (time frame: 1-3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Oct 2010; AzTrials last refreshed its copy on 31 Oct 2026.