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

NCT01128049 | Completed Results

• 1 other identifier: B&L 32280
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

Aqueous Deficient Dry Eye; Meibomium Gland Dysfunction

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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.

  5 seconds

Study Arms (3)

Normal Patient Population

ACTIVE COMPARATOR

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

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

MGD Patient Population

ACTIVE COMPARATOR

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

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

ADDE Population

ACTIVE COMPARATOR

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

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

Interventions

Subjective Questionnaire 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.

ADDE Population; MGD Patient Population; Normal Patient Population

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

ADDE Population; MGD Patient Population; Normal Patient Population

Instill Saline Drop 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.

Also known as: Ocufresh eye wash

ADDE Population; MGD Patient Population; Normal Patient Population

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.
• 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

Sponsors & Collaborators

• University of Rochester: lead
• Bausch & Lomb Incorporated: collaborator

Study Sites (1)

The Flaum Eye Institute-University of Rochester

Rochester, New York, 14642, United States

Location

MeSH Terms

Interventions

Weights and Measures

Intervention Hierarchy (Ancestors)

Investigative Techniques

Results Point of Contact

• Title: James Aquavella, MD
• Organization: University of Rochester Medical Center, Flaum Eye Institute

James_Aquavella@URMC.Rochester.Edu

585-275-8944

Study Officials

• James V Aquavella, MD

  University of Rochester

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Doctor and Department Faculty

Study Record Dates

• First Submitted: May 19, 2010
• First Posted: May 21, 2010
• Study Start: June 1, 2010
• Primary Completion: December 1, 2011
• Study Completion: December 1, 2011
• Last Updated: August 7, 2015
• Results First Posted: June 11, 2015

Record last verified: 2015-08

Locations

US (1)