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

NCT ID: NCT01128049

Last Updated: 2015-08-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-06-30
• Study Completion Date: 2011-12-31

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.

Conditions

Aqueous Deficient Dry Eye; Meibomium Gland Dysfunction

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Normal Patient Population

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

Group Type: ACTIVE_COMPARATOR

Subjective Questionnaire

Intervention Type: 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.

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

Intervention Type: 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.

Instill Saline Drop

Intervention Type: 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.

MGD Patient Population

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

Group Type: ACTIVE_COMPARATOR

Subjective Questionnaire

Intervention Type: 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.

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

Intervention Type: 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.

Instill Saline Drop

Intervention Type: 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.

ADDE Population

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

Group Type: ACTIVE_COMPARATOR

Subjective Questionnaire

Intervention Type: 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.

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

Intervention Type: 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.

Instill Saline Drop

Intervention Type: 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.

Interventions

Subjective 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.

Intervention Type: BEHAVIORAL

Measurement 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.

Intervention Type: PROCEDURE

Instill 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.

Intervention Type: DRUG

Other Intervention Names

Ocufresh eye wash

Eligibility Criteria

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).

• 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

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.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Bausch & Lomb Incorporated

INDUSTRY

Sponsor Role: collaborator

University of Rochester

OTHER

Sponsor Role: lead

Responsible Party

James V. Aquavella, MD

Medical Doctor and Department Faculty

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

James V Aquavella, MD

Role: PRINCIPAL_INVESTIGATOR

University of Rochester

Locations

The Flaum Eye Institute-University of Rochester

Rochester, New York, United States

Countries

United States

Other Identifiers

B&L 32280

Identifier Type: -

Identifier Source: org_study_id