Dry Eye DiseaseNCT02042820
Ocular Surface Immune Response in Dry Eye Disease
An observational study of Dry Eye Disease, run by Tufts Medical Center at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Dry Eye Disease
- What is being tested?
- In vivo confocal microscopy (IVCM)
- How many people
- 67 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2014to Jul 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients with and without Dry Eye Disease
Who may be able to join
- 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
Show all 11Show fewer
- 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
Who cannot join
- 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
Show all 17Show fewer
- For Age-Match Controls
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts Eye and Ear Infirmary
Boston, Massachusetts, 02114
About this study
Official title: 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.
- Conditions
- Dry Eye Disease
- Being tested
- In vivo confocal microscopy (IVCM)
- Keywords
- Dry Eye
- Medical subject headings
- Dry Eye Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
In vivo confocal microscopy (IVCM)Other
IVCM is a sensitive tool for detecting dry eye-associated subclinical inflammation.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: In vivo confocal microscopy (IVCM) | |
| 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 Receives: Other: In vivo confocal microscopy (IVCM) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peripheral Corneal Immune cell Status by IVCM
Peripheral Corneal Immune cell Status by IVCM • Density of dendritic immune cells • Density of non-dendritic immune cells • Morphology of immune cells
Measured: Visit 1
Bulbar conjunctival immune cell Status by IVCM
Bulbar conjunctival immune cell Status by IVCM • Density of dendritic immune cells • Density of non-dendritic immune cells • Morphology of immune cells
Measured: Visit 1
Secondary outcomes (6)
Clinical Parameter: Ocular Surface Disease Index (OSDI)
Measured: Visit 1
Clinical Parameter: Schirmer's II test
Measured: Visit 1
Clinical Parameter: Conjunctival staining with lissamine green
Measured: Visit 1
Clinical Parameter: Corneal staining with fluorescein
Measured: Visit 1
Clinical Parameter: Tear Break Up Time (TBUT)
Measured: Visit 1
Clinical Parameter: Conjunctival redness
Measured: Visit 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2014 (estimated)
- Study startJan 2014
- Primary completionJul 2015
- Study completionJul 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dry Eye DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 67 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tufts Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pedram Hamrah, MD, Principal investigator, MEEI
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02042820
- Sponsor's protocol ID
- 13-149H
- Status last verified
- Oct 2017
- First submitted
- 17 Jan 2014
- Last updated
- 18 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT02042820
- Acronym / sponsor ID
- 13-149H
- Conditions
- Dry Eye Disease
- Keywords
- Dry Eye
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 67 participants (actual)
- Lead sponsor
- Tufts Medical CenterUniversity, hospital or other
- Study start
- Jan 2014
- Primary completion
- Jul 2015 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 23 Jan 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dry Eye Disease | – | Other: In vivo confocal microscopy (IVCM)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 |
| Control | – | Other: In vivo confocal microscopy (IVCM)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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with and without Dry Eye Disease
Key inclusion criteria (11 listed)
- 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
Key exclusion criteria (17 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| In vivo confocal microscopy (IVCM)IVCM is a sensitive tool for detecting dry eye-associated subclinical inflammation. | Other | Control, Dry Eye Disease |
Primary outcome
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
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
6 secondary outcomes
Clinical Parameter: Ocular Surface Disease Index (OSDI)
Time frame: Visit 1
Clinical Parameter: Schirmer's II test
Time frame: Visit 1
Clinical Parameter: Conjunctival staining with lissamine green
Time frame: Visit 1
Clinical Parameter: Corneal staining with fluorescein
Time frame: Visit 1
Clinical Parameter: Tear Break Up Time (TBUT)
Time frame: Visit 1
Clinical Parameter: Conjunctival redness
Time frame: Visit 1
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Oct 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pedram Hamrah, MD principal investigator
MEEI
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Dry Eye Disease, run by Tufts Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Peripheral Corneal Immune cell Status by IVCM (time frame: Visit 1). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Oct 2017.