Aqueous Deficient Dry Eye, Meibomium Gland Dysfunction
Conditions
Keywords
Aqueous deficient dry eye (ADDE), Meibomium Gland Dysfunction (MGD), Normal/Control (Non Dry Eye)
Brief summary
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
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.
Interventions
BEHAVIORALSubjective Questionnaire
The team will use a one page questionnaire to obtain subjective input before the first set of measurements and after instilling the Saline drop.
PROCEDUREMeasurement with wavefront sensor (right eye, then left eye)
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.
DRUGInstill Saline Drop
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.
Sponsors
Bausch & Lomb Incorporated
University of Rochester
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Visual Quality | 5 seconds | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 5 |
| MGD Patient Population Subjects with a meibomian gland dysfunction on a slitlamp examination with a fluorescein tear break-up time \<5 secs. | 5 |
| ADDE Population Subjects with schirmer's value \< 10mm/5 mins and no meibomian gland dysfunction. | 5 |
| Total | 15 |
Baseline characteristics
| Characteristic | Normal Patient Population | MGD Patient Population | ADDE Population | Total |
|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 5 Participants | 5 Participants | 5 Participants | 15 Participants |
| Region of Enrollment United States | 5 participants | 5 participants | 5 participants | 15 participants |
| Sex: Female, Male Female | 3 Participants | 2 Participants | 5 Participants | 10 Participants |
| Sex: Female, Male Male | 2 Participants | 3 Participants | 0 Participants | 5 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 5 | 0 / 5 | 0 / 5 |
| serious Total, serious adverse events | 0 / 5 | 0 / 5 | 0 / 5 |
Outcome results
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.
Time frame: 5 seconds
Population: The comparison was between normal, non-dry eye participants and dry eye groups.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Normal | Visual Quality | Visual Quality at Baseline | 0.3 microns | Standard Deviation 0.07 |
| Normal | Visual Quality | Visual Quality at 5 minutes after Saline | 0.3 microns | Standard Deviation 0.08 |
| Meibomian Gland Dysfunction (MGD) | Visual Quality | Visual Quality at Baseline | 0.32 microns | Standard Deviation 0.08 |
| Meibomian Gland Dysfunction (MGD) | Visual Quality | Visual Quality at 5 minutes after Saline | 0.33 microns | Standard Deviation 0.08 |
| Aqueous Deficiency Dry Eye (ADDE) | Visual Quality | Visual Quality at Baseline | 0.19 microns | Standard Deviation 0.06 |
| Aqueous Deficiency Dry Eye (ADDE) | Visual Quality | Visual Quality at 5 minutes after Saline | 0.23 microns | Standard Deviation 0.05 |