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

University of Rochester

Status: Completed

Conditions: Aqueous Deficient Dry Eye; Meibomium Gland Dysfunction

Treatments: Behavioral: Subjective Questionnaire; Drug: Instill Saline Drop; Procedure: Measurement with wavefront sensor (right eye, then left eye)

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01128049

B&L 32280

Details and patient eligibility

About

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.

Full 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.

Enrollment: 15 patients

Sex: All

Ages: 20 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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15 participants in 3 patient groups

Normal Patient Population

Active Comparator group

Description:

Non-Dry Eye patient population (intervention remains the same across all arms)

Treatment:

Behavioral: Subjective Questionnaire

Drug: Instill Saline Drop

Procedure: Measurement with wavefront sensor (right eye, then left eye)

MGD Patient Population

Active Comparator group

Description:

Meibomium Gland Dysfunction population(intervention remains the same across all arms)

Treatment:

Behavioral: Subjective Questionnaire

Drug: Instill Saline Drop

Procedure: Measurement with wavefront sensor (right eye, then left eye)

ADDE Population

Active Comparator group

Description:

Aqueous Deficient Dry Eye population(intervention remains the same across all arms)

Treatment:

Behavioral: Subjective Questionnaire

Drug: Instill Saline Drop

Procedure: Measurement with wavefront sensor (right eye, then left eye)