Clinical trial NCT01128049: Non-invasive Tear Film Dynamic Measurements in Normal, MGD and ADDE Subjects After Saline Instillation
Official title: Non-invasive Tear Film Dynamic Measurements in Normal, MGD (Meibomium Gland Dysfunction) and Aqueous Deficient Dry Eye(ADDE) Subjects After Saline Instillation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Aqueous Deficient Dry Eye
Meibomium Gland Dysfunction
Keywords: Aqueous deficient dry eye (ADDE)
Meibomium Gland Dysfunction (MGD)
Normal/Control (Non Dry Eye)
Lead sponsor: University of Rochester
Sponsor class: OTHER
Collaborators: name: Bausch & Lomb Incorporated
First posted: 2010-05-21
Enrollment: 15
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.

Eligibility 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 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

Primary outcomes:
measure: Visual Quality
timeFrame: 5 seconds
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: The Flaum Eye Institute-University of Rochester
state: New York
Study officials:
affiliation: University of Rochester
name: James V Aquavella, MD
role: PRINCIPAL_INVESTIGATOR
References: