Non-invasive Tear Film Dynamic Measurements in Normal, MGD (Meibomium Gland Dysfunction) and Aqueous Deficient Dry Eye(ADDE) Subjects After Saline Instillation

This study has been completed.
Sponsor:
Collaborator:
Bausch & Lomb Incorporated
Information provided by (Responsible Party):
University of Rochester
ClinicalTrials.gov Identifier:
NCT01128049
First received: May 19, 2010
Last updated: July 24, 2012
Last verified: July 2012
  Purpose

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.


Condition Intervention
Aqueous Deficient Dry Eye
Meibomium Gland Dysfunction
Other: Slit Lamp Exam
Behavioral: Subjective Questionnaire
Procedure: Measurement with wavefront sensor (right eye, then left eye)
Procedure: Measurement with ellipsometer (right eye, then left eye)
Drug: Instill Saline Drop

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Non-invasive Tear Film Dynamic Measurements in Normal, MGD and ADDE Subjects After Saline Instillation

Resource links provided by NLM:


Further study details as provided by University of Rochester:

Primary Outcome Measures:
  • Outcome Measure [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Patients will have measurement pre and post drop instillation for tear dynamics with non-invasive instruments.


Enrollment: 20
Study Start Date: June 2010
Study Completion Date: December 2011
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Normal Patient Population
Non-Dry Eye patient population (intervention remains the same across all arms)
Other: Slit Lamp Exam
This is an abbreviated exam that was performed when the subject was screened for the study. It includes reviewing the subject's medical history and the slit lamp examination; however, it will not include the fluoroscein dye or Schirmer's I tests. We will ask the subject to verify he or she has no health or eye issues that would preclude participation in the study (such as the subject used warm compresses). This procedure and all those for the study will occur in the environmentally controlled chamber room or in an exam room located in the research area.
Behavioral: 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.
Procedure: 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.
Procedure: Measurement with ellipsometer (right eye, then left eye)

The ellipsometer imaging system allows visualization of the surface of the subject's cornea. This system is similar to a clinical slit-lamp examination system; where as the slit lamp uses a human observer, the ellipsometer uses an electronic camera and instead of the slit lamp illuminator, the ellipsometer uses a diffuse ring illuminator. Images captured from this system can be processed to measure the lipid thickness and refractive index over the cornea.

Taking these measurements is very similar to taking wavefront measurements. We have the subject sit and use a chin rest. We will start recording data asking the subject to either blink naturally or to hold his/her eye open. Measurements will be made during each of three blink intervals at five frames/ second. Each blink interval is 10-15 seconds.

Drug: Instill Saline Drop
One drop will be instilled in both eyes and patient will wait 5 minutes prior to repeating the questionnaire, wavefront sensor and ellipsometer. A single drop is approximately 30 µL and will be placed into the inferior cul-de-sac while the patient looks up.
Other Name: Ocufresh eye wash (purified water 99.1% by volume, sodium chloride 0.9% by weight. Osmolality 252 mOsm/kg, PH 5.84, for single use no preservative added).
Active Comparator: MGD Patient Population
Meibomium Gland Dysfunction population(intervention remains the same across all arms)
Other: Slit Lamp Exam
This is an abbreviated exam that was performed when the subject was screened for the study. It includes reviewing the subject's medical history and the slit lamp examination; however, it will not include the fluoroscein dye or Schirmer's I tests. We will ask the subject to verify he or she has no health or eye issues that would preclude participation in the study (such as the subject used warm compresses). This procedure and all those for the study will occur in the environmentally controlled chamber room or in an exam room located in the research area.
Behavioral: 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.
Procedure: 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.
Procedure: Measurement with ellipsometer (right eye, then left eye)

The ellipsometer imaging system allows visualization of the surface of the subject's cornea. This system is similar to a clinical slit-lamp examination system; where as the slit lamp uses a human observer, the ellipsometer uses an electronic camera and instead of the slit lamp illuminator, the ellipsometer uses a diffuse ring illuminator. Images captured from this system can be processed to measure the lipid thickness and refractive index over the cornea.

Taking these measurements is very similar to taking wavefront measurements. We have the subject sit and use a chin rest. We will start recording data asking the subject to either blink naturally or to hold his/her eye open. Measurements will be made during each of three blink intervals at five frames/ second. Each blink interval is 10-15 seconds.

Drug: Instill Saline Drop
One drop will be instilled in both eyes and patient will wait 5 minutes prior to repeating the questionnaire, wavefront sensor and ellipsometer. A single drop is approximately 30 µL and will be placed into the inferior cul-de-sac while the patient looks up.
Other Name: Ocufresh eye wash (purified water 99.1% by volume, sodium chloride 0.9% by weight. Osmolality 252 mOsm/kg, PH 5.84, for single use no preservative added).
Active Comparator: ADDE Population
Aqueous Deficient Dry Eye population(intervention remains the same across all arms)
Other: Slit Lamp Exam
This is an abbreviated exam that was performed when the subject was screened for the study. It includes reviewing the subject's medical history and the slit lamp examination; however, it will not include the fluoroscein dye or Schirmer's I tests. We will ask the subject to verify he or she has no health or eye issues that would preclude participation in the study (such as the subject used warm compresses). This procedure and all those for the study will occur in the environmentally controlled chamber room or in an exam room located in the research area.
Behavioral: 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.
Procedure: 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.
Procedure: Measurement with ellipsometer (right eye, then left eye)

The ellipsometer imaging system allows visualization of the surface of the subject's cornea. This system is similar to a clinical slit-lamp examination system; where as the slit lamp uses a human observer, the ellipsometer uses an electronic camera and instead of the slit lamp illuminator, the ellipsometer uses a diffuse ring illuminator. Images captured from this system can be processed to measure the lipid thickness and refractive index over the cornea.

Taking these measurements is very similar to taking wavefront measurements. We have the subject sit and use a chin rest. We will start recording data asking the subject to either blink naturally or to hold his/her eye open. Measurements will be made during each of three blink intervals at five frames/ second. Each blink interval is 10-15 seconds.

Drug: Instill Saline Drop
One drop will be instilled in both eyes and patient will wait 5 minutes prior to repeating the questionnaire, wavefront sensor and ellipsometer. A single drop is approximately 30 µL and will be placed into the inferior cul-de-sac while the patient looks up.
Other Name: Ocufresh eye wash (purified water 99.1% by volume, sodium chloride 0.9% by weight. Osmolality 252 mOsm/kg, PH 5.84, for single use no preservative added).

  Eligibility

Ages Eligible for Study:   20 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01128049

Locations
United States, New York
The Flaum Eye Institute-University of Rochester
Rochester, New York, United States, 14642
Sponsors and Collaborators
University of Rochester
Bausch & Lomb Incorporated
Investigators
Principal Investigator: James V Aquavella, MD University of Rochester
  More Information

No publications provided

Responsible Party: University of Rochester
ClinicalTrials.gov Identifier: NCT01128049     History of Changes
Other Study ID Numbers: B&L 32280
Study First Received: May 19, 2010
Last Updated: July 24, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by University of Rochester:
Aqueous deficient dry eye (ADDE)
Meibomium Gland Dysfunction (MGD)
Normal/Control (Non Dry Eye)

Additional relevant MeSH terms:
Keratoconjunctivitis Sicca
Dry Eye Syndromes
Keratoconjunctivitis
Conjunctivitis
Conjunctival Diseases
Eye Diseases
Keratitis
Corneal Diseases
Lacrimal Apparatus Diseases

ClinicalTrials.gov processed this record on July 26, 2014