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

Primary Purpose

Aqueous Deficient Dry Eye, Meibomium Gland Dysfunction

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Subjective Questionnaire

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

Instill Saline Drop

About this trial

This is an interventional diagnostic trial for Aqueous Deficient Dry Eye focused on measuring Aqueous deficient dry eye (ADDE), Meibomium Gland Dysfunction (MGD), Normal/Control (Non Dry Eye)

Eligibility Criteria

20 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

The Flaum Eye Institute-University of Rochester

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Arm Label

Normal Patient Population

MGD Patient Population

ADDE Population

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

NCT ID

NCT01128049

First Posted

May 19, 2010

Last Updated

August 5, 2015

Sponsor

University of Rochester

Collaborators

Bausch & Lomb Incorporated

1. Study Identification

Unique Protocol Identification Number

NCT01128049

Brief Title

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

2. Study Status

Record Verification Date

August 2015

Overall Recruitment Status

Completed

Study Start Date

June 2010 (undefined)

Primary Completion Date

December 2011 (Actual)

Study Completion Date

December 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Rochester

Collaborators

Bausch & Lomb Incorporated

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Aqueous Deficient Dry Eye, Meibomium Gland Dysfunction

Keywords

Aqueous deficient dry eye (ADDE), Meibomium Gland Dysfunction (MGD), Normal/Control (Non Dry Eye)

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

15 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Normal Patient Population

Arm Type

Active Comparator

Arm Description

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

Arm Title

MGD Patient Population

Arm Type

Active Comparator

Arm Description

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

Arm Title

ADDE Population

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Behavioral

Intervention Name(s)

Subjective Questionnaire

Intervention Description

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

Procedure

Intervention Name(s)

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

Intervention Description

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

Drug

Intervention Name(s)

Instill Saline Drop

Other Intervention Name(s)

Ocufresh eye wash

Intervention Description

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.

Primary Outcome Measure Information:

Title

Visual Quality

Description

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

James V Aquavella, MD

Organizational Affiliation

University of Rochester

Official's Role

Principal Investigator

Facility Information:

Facility Name

The Flaum Eye Institute-University of Rochester

City

Rochester

State/Province

New York

ZIP/Postal Code

14642

Country

United States

12. IPD Sharing Statement

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

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