Ocular Surface Immune Response in Dry Eye Disease

October 16, 2017 updated by: Tufts Medical Center

Ocular Surface Immune Response in Dry Eye Disease: Analysis of Conjunctival and Peripheral Corneal Immune Cell Alterations by In Vivo Confocal Microscopy and Clinical Correlation

In vivo confocal microscopy (IVCM) is a sensitive imaging tool for detecting dry eye-associated subclinical inflammation. Studies have previously shown that IVCM provides an in vivo metric to measure inflammatory changes in the central cornea. The objective of the current study is to assess inflammatory response changes in the peripheral cornea and the conjunctiva by analyzing epithelial immune cell density and morphology in these areas and then correlating the IVCM findings to clinical signs and symptoms to establish novel objective imaging biomarkers.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
67

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Massachusetts Eye and Ear Infirmary

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with and without Dry Eye Disease

Description

For Dry Eye Disease Participants

Inclusion Criteria:

  • Age >18
  • Ability to consent to study
  • Symptoms of dry eye disease for at least 6 months, such foreign body sensation, burning, stinging, light sensitivity
  • Positive vital dye staining of the cornea
  • At least one of the following objective signs: (Schirmer I <10 mm at 5 minutes), decreased (<0.2 mm) tear meniscus, decreased tear breakup time (TBUT) of <10 seconds, positive vital dye staining of the conjunctiva

For Age-Match Controls

Inclusion Criteria:

  • Between the ages of 18-89
  • The ability to provide informed consent for study inclusion
  • Clear, healthy cornea
  • Normal tear meniscus (> 0.3 mm)

For Dry Eye Disease Participants

Exclusion Criteria:

  • History of contact lens wear in the past 3 months
  • History of ocular surgery in the past 6 months
  • Active ocular allergies
  • History of ocular infection in the past 3 months
  • History of diabetes
  • History of topical or systemic anti-inflammatory therapy in the past 1 month

For Age-Match Controls

Exclusion Criteria:

  • History of ocular or eyelid surgery within the past 12 months
  • History of herpetic or other infectious keratitis or other inflammatory eye disease
  • History of any other acute ocular disease
  • Current use of topical medications (not including artificial tears)
  • Current use of contact lenses
  • History of ocular carcinoma or any recent ocular topical chemotherapy or radiotherapy
  • History of cancer elsewhere in the body which is currently under systemic chemotherapy
  • Current glaucoma disease requiring use of glaucoma drops
  • History of Diabetes mellitus
  • Current diagnosis of dry eye disease

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Dry Eye Disease

Confocal Imaging - In vivo confocal microscopy (IVCM)

Ophthalmic Examination:

  • Tear Break Up Time (TBUT)
  • Ocular Surface Disease Index (OSDI)
  • Schirmer's II test
  • Conjunctival staining with lissamine green
  • Corneal staining with fluorescein
  • Conjunctival redness assessment
Other: In vivo confocal microscopy (IVCM)
IVCM is a sensitive tool for detecting dry eye-associated subclinical inflammation.
Control

Confocal Imaging - In vivo confocal microscopy (IVCM)

Ophthalmic Examination:

  • TBUT
  • OSDI
  • Schirmer's II test
  • Conjunctival staining with lissamine green
  • Corneal staining with fluorescein
  • Conjunctival redness assessment
Other: In vivo confocal microscopy (IVCM)
IVCM is a sensitive tool for detecting dry eye-associated subclinical inflammation.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Peripheral Corneal Immune cell Status by IVCM
Time Frame: Visit 1
Peripheral Corneal Immune cell Status by IVCM • Density of dendritic immune cells • Density of non-dendritic immune cells • Morphology of immune cells
Visit 1
Bulbar conjunctival immune cell Status by IVCM
Time Frame: Visit 1
Bulbar conjunctival immune cell Status by IVCM • Density of dendritic immune cells • Density of non-dendritic immune cells • Morphology of immune cells
Visit 1

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Clinical Parameter: Ocular Surface Disease Index (OSDI)
Time Frame: Visit 1
Visit 1
Clinical Parameter: Schirmer's II test
Time Frame: Visit 1
Visit 1
Clinical Parameter: Conjunctival staining with lissamine green
Time Frame: Visit 1
Visit 1
Clinical Parameter: Corneal staining with fluorescein
Time Frame: Visit 1
Visit 1
Clinical Parameter: Tear Break Up Time (TBUT)
Time Frame: Visit 1
Visit 1
Clinical Parameter: Conjunctival redness
Time Frame: Visit 1
Visit 1

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Tufts Medical Center

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Pedram Hamrah, MD, MEEI

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2014

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 1, 2015

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 1, 2015

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 17, 2014

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 20, 2014

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 23, 2014

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 18, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 16, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 13-149H

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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