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| Name | Class |
|---|---|
| Bausch & Lomb Incorporated | INDUSTRY |
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Compare the objective tear film dynamic measurements in three different populations (MGD [Meibomium Gland Dysfunction], ADDE [Aqueous Deficient Dry Eye] and normal/control [non-dry eye]) and the subjective experience before and after instilling a single drop of saline in each eye.
Currently available office-based tests for dry eye do not reliably correlate with patients' subjective symptoms. This study is interested in assessing how individuals with these two different ocular surface diseases compare with the normal population when measured objectively using two different instruments.
There will be one study day with a single visit that will consist of taking two sets of measurements. Baseline measurements are taken in both eyes using a wavefront sensor to measure visual quality followed by saline instillation. Five minutes after drops, visual quality is again measured to evaluate changes in tear dynamics.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Normal Patient Population | Active Comparator | Non-Dry Eye patient population (intervention remains the same across all arms) |
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| MGD Patient Population | Active Comparator | Meibomium Gland Dysfunction population(intervention remains the same across all arms) |
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| ADDE Population | Active Comparator | Aqueous Deficient Dry Eye population(intervention remains the same across all arms) |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Subjective Questionnaire | Behavioral | The team will use a one page questionnaire to obtain subjective input before the first set of measurements and after instilling the Saline drop. |
| Measure | Description | Time Frame |
|---|---|---|
| Visual Quality | Average visual quality change over a 5 second blink cycle caused by movement of the tears over the surface of the eye by measuring optical irregularities. | 5 seconds |
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General Inclusion Criteria:
General Exclusion Criteria:
Cohort Specific Inclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| James V Aquavella, MD | University of Rochester | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Flaum Eye Institute-University of Rochester | Rochester | New York | 14642 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Normal Patient Population | Subjects with no symptoms and no diagnosis of dry eye. Schirmer's value ≥ 10mm/5 mins and a fluorescein tear break-up time >5 secs with no surface staining. |
| FG001 | MGD Patient Population |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Measurement with wavefront sensor (right eye, then left eye) | Procedure | The wavefront instrument measures the eye's ability to create a sharp image by briefly shining a laser light from the wavefront sensor into the eye and measuring the light that bounces back through the cornea. For these measurements, subjects will sit on a chair and be instructed to place their chin in a chin rest and lean their forehead against a forehead rest. The subject will be instructed to hold his/her head steady, look in a certain direction, blink or not blink. We will obtain the measurements over a short period of up to approximately 45 seconds. We will start recording data asking the subject to either blink naturally or to hold his/her eye open for a few (up to 10) seconds, and repeat the blink and hold sequence usually for up to four times. |
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| Instill Saline Drop | Drug | One drop will be instilled in both eyes and patient will wait 5 minutes prior to repeating the questionnaire and wavefront sensor. A single drop is approximately 30 µL and will be placed into the inferior cul-de-sac while the patient looks up. |
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Subjects with a meibomian gland dysfunction on a slitlamp examination with a fluorescein tear break-up time <5 secs.
| FG002 | ADDE Population | Subjects with schirmer's value < 10mm/5 mins and no meibomian gland dysfunction. |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Normal Patient Population | Subjects with no symptoms and no diagnosis of dry eye. Schirmer's value ≥ 10mm/5 mins and a fluorescein tear break-up time >5 secs with no surface staining. |
| BG001 | MGD Patient Population | Subjects with a meibomian gland dysfunction on a slitlamp examination with a fluorescein tear break-up time <5 secs. |
| BG002 | ADDE Population | Subjects with schirmer's value < 10mm/5 mins and no meibomian gland dysfunction. |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Visual Quality | Average visual quality change over a 5 second blink cycle caused by movement of the tears over the surface of the eye by measuring optical irregularities. | The comparison was between normal, non-dry eye participants and dry eye groups. | Posted | Mean | Standard Deviation | microns | 5 seconds |
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Over 1 year
No Adverse Events were reported.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Normal Patient Population | Non-Dry Eye patient population (intervention remains the same across all arms) | 0 | 5 | 0 | 5 | ||
| EG001 | MGD Patient Population | Meibomium Gland Dysfunction population(intervention remains the same across all arms) | 0 | 5 | 0 | 5 | ||
| EG002 | ADDE Population | Aqueous Deficient Dry Eye population(intervention remains the same across all arms) | 0 | 5 | 0 | 5 |
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Sponsor review required before publishing results.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| James Aquavella, MD | University of Rochester Medical Center, Flaum Eye Institute | 585-275-8944 | James_Aquavella@URMC.Rochester.Edu |
| ID | Term |
|---|---|
| D014894 | Weights and Measures |
| ID | Term |
|---|---|
| D008919 | Investigative Techniques |
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| Between 18 and 65 years |
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| >=65 years |
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| Male |
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