Non-invasive Tear Film Dynamic Measurements in Normal, MGD and ADDE Subjects After Saline Instillation

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Non-invasive Tear Film Dynamic Measurements in Normal, MGD (Meibomium Gland Dysfunction) and Aqueous Deficient Dry Eye(ADDE) Subjects After Saline Instillation

Conditions
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Aqueous Deficient Dry Eye, Meibomium Gland Dysfunction

Intervention / Treatment
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* Behavioral: Subjective Questionnaire
* Procedure: Measurement with wavefront sensor (right eye, then left eye)
* Drug: Instill Saline Drop


Participation Criteria
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Eligibility Criteria
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General Inclusion Criteria: Good general Health The subject must appear able and willing to adhere to the instructions set forth in this protocol (such as not use warm compresses or artificial tears/lubricant or excessive eye makeup before the visit on the study day). General Exclusion Criteria: Ocular disease, infection or inflammation (allergy, blepharitis) that is clinically significant (grade 3 or 4) that in the opinion of the PI would not be a good subject. Systemic disease or use of medication that in the opinion of the PI would not be a good subject. Infectious diseases (e.g. hepatitis, tuberculosis) or an immuno-suppressive disease (e.g. HIV). Contact lens wearer. Pregnancy or lactation. Diabetes. Inclusion or exclusion criteria of the other cohorts. Cohort Specific Inclusion Criteria: ADDE cohort: Schirmer I < 10 mm, BUT ¬< 5 seconds, Fluorescein 0 or 1, currently using an artificial tear for ocular comfort at least occasionally. MGD cohort: Diagnosis of moderate or severe MGD Normal/Control (Non Dry-Eye): meets general inclusion and exclusion criteria

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Normal Patient Population<br>Non-Dry Eye patient population (intervention remains the same across all arms) | Behavioral: Subjective Questionnaire<br>* The team will use a one page questionnaire to obtain subjective input before the first set of measurements and after instilling the Saline drop.<br>Procedure: Measurement with wavefront sensor (right eye, then left eye)<br>* 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.<br>Drug: Instill Saline Drop<br>* 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.<br>* Other names: Ocufresh eye wash;|
| Active Comparator: MGD Patient Population<br>Meibomium Gland Dysfunction population(intervention remains the same across all arms) | Behavioral: Subjective Questionnaire<br>* The team will use a one page questionnaire to obtain subjective input before the first set of measurements and after instilling the Saline drop.<br>Procedure: Measurement with wavefront sensor (right eye, then left eye)<br>* 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.<br>Drug: Instill Saline Drop<br>* 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.<br>* Other names: Ocufresh eye wash;|
| Active Comparator: ADDE Population<br>Aqueous Deficient Dry Eye population(intervention remains the same across all arms) | Behavioral: Subjective Questionnaire<br>* The team will use a one page questionnaire to obtain subjective input before the first set of measurements and after instilling the Saline drop.<br>Procedure: Measurement with wavefront sensor (right eye, then left eye)<br>* 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.<br>Drug: Instill Saline Drop<br>* 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.<br>* Other names: Ocufresh eye wash;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Aqueous deficient dry eye (ADDE), Meibomium Gland Dysfunction (MGD), Normal/Control (Non Dry Eye)