Dry Eye DiseasePhase 4NCT02120079
The Utility of IVCM to Assess Cellular Response and Efficacy of Long-term Topical Steroid Treatment in Patients With DED
A Phase 4 study testing Lotemax, Soothe Tired Eyes Lubricant Eye Drop (Artificial Tears) and In Vivo Confocal Microscopy (IVCM) in people with Dry Eye Disease, run by Tufts Medical Center at 1 site in United States.
Trial summary
This research study is looking to see if in vivo confocal microscopy (IVCM) imaging can be used to confirm clinical findings (which are noted by the doctor during an eye exam) and measure the immune response to the inflammation in the subject's cornea (the front part of the eyeball). Read more about this study
- Who is it for?
- Ages 18 to 89 years
- Conditions the study is for
- Dry Eye Disease
- What is being tested?
- Lotemax, Soothe Tired Eyes Lubricant Eye Drop (Artificial Tears) and In Vivo Confocal Microscopy (IVCM)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2014to 28 Jan 2018
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 to 89 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18-89 years.
- Willing and able to provide written informed consent.
- Willing and able to comply with study assessments for the full duration of the study.
- In good stable overall health.
- Corneal dendritiform cell count by confocal microscopy of >=75/mm2 (13 immune cells per image)
- Diagnosis of dry eye disease based on the followings:
Show all 12Show fewer
- Symptoms of dry eye disease such as foreign body sensation, burning, stinging, light sensitivity for at least 6 months.
- Two or more of the following objective signs:
- Schirmer test with anesthesia <10 mm at 5 minutes [mean Schirmer between eyes.
- Tear break-up time (TBUT) of <10 seconds.
- Corneal fluorescein staining of 4 (NEI grading scheme, 0-15) in at least one eye
- Lissamine green staining of the nasal and temporal conjunctiva (NEI grading scheme, 0-18) in at least one eye
Who cannot join
- Central corneal subbasal dendritic cell count by in vivo confocal microscopy of <75/mm2 in both eyes
- Active ocular allergies
- Active allergies to steroids, aminoglycosides, or benzalkonium chloride (BAK)
- History of contact lens wear within 3 months before enrollment.
- Intraocular surgery or ocular laser surgery within 3 months before enrollment.
- History of ocular infection within 3 months before enrollment.
Show all 11Show fewer
- History of topical (for ophthalmic use) or systemic steroid treatment (Loteprednol (other than Lotemax suspension used in our study), Difluprednate, Fluorometholone, Prednisolone, Dexamethasone, Triamcinolone, Rimexolone, Medrysone) within 1 month before enrollment. In case of topical ophthalmic steroid use, a wash-out period of 1 month is required.
- History of increased intraocular pressure after using topical steroids (steroid responsive)
- Change in systemic immunosuppression medication in the past 3 months.
- History of any change in the frequency of topical cyclosporine or oral tetracycline compounds (tetracycline, doxycycline, and minocycline) within 1 month before enrollment.
- Any condition (including language barrier) that precludes subject's ability to comply with study requirements including completion of study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Utility of in Vivo Confocal Microscopy (IVCM) to Assess Cellular Response and Efficacy of Long-term Topical Steroid Treatment in Patients With Dry Eye Disease (DED)
This research study is looking to see if in vivo confocal microscopy (IVCM) imaging can be used to confirm clinical findings (which are noted by the doctor during an eye exam) and measure the immune response to the inflammation in the subject's cornea (the front part of the eyeball).
Additionally, this study is trying to determine the effectiveness of two eye-drops, Lotemax and artificial tears, in treating the inflammation associated with DED by measuring changes in immune cells with IVCM imaging. The subject will be treated with either Lotemax (loteprednol) or artificial tears (a lubricating eye drop with no medication). Lotemax is an FDA-approved steroid eye-drop that is often used to treat inflammation associated with DED. Artificial tears are approved by the FDA for treatment of dryness associated with DED.
Thus, this study is designed to determine the effects of the administration of a topical steroid, Lotemax, over a treatment period of 6 weeks, using novel methods of detecting efficacy. In order to achieve the aforementioned goal, subjects will be prospectively randomized to one of two treatment arms - Lotemax or artificial tear. Both groups will follow the same study schedule.
Read the detailed description
IVCM is a non-invasive imaging technique that images the cornea at a cellular level with 800x magnification, using a scanning laser. The laser is used to map the cornea, and will not damage or harm the subject's eye. Studies have shown that IVCM can be used to study cells and nerves within the cornea, providing a better understanding of how the cornea reacts to irritants. IVCM has recently been used by the investigator to assess the extent of eye inflammation in cases of dry eye patients.
Current steroid therapy in dry eye disease (DED) is comprised of a 2 week duration of pulse therapy, administered twice daily (to avoid adverse effects associated with long-term steroid use). This time frame is often too short to meaningfully resolve the inflammation associated with DED. DED often occurs when there is a decrease in the eye's tear production or if there is an increase in the evaporation of the tear film (a thin layer of tears that keep the eye moist). Eye irritation and inflammation (swelling) is often associated with DED because the surface of the eye is unable to maintain a normal level of moisture.
- Conditions
- Dry Eye Disease
- Being tested
- Lotemax, Soothe Tired Eyes Lubricant Eye Drop (Artificial Tears), 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.
LotemaxDrug
Also called Lotemax (loteprednol etabonate) 0.5%
Lotemax (loteprednol etabonate) 0.5% will be applied topically to both eyes for 6 weeks with the following regimen: four times a day for 2 weeks, twice daily for 2 weeks, and once daily for 2 weeks.
Soothe Tired Eyes Lubricant Eye Drop (Artificial Tears)Drug
Also called Soothe Tired Eyes Lubricant Eye Drop (Bausch & Lomb Inc.)
Soothe Tired Eyes Lubricant Eye Drop will be applied topically to both eyes for 6 weeks with the following regimen: four times a day for 2 weeks, twice daily for 2 weeks, and once daily for 2 weeks.
In Vivo Confocal Microscopy (IVCM)Diagnostic test
In vivo confocal microscopy (IVCM) is a new imaging method, which allows visualization of the corneal structures at the cellular level. With a magnification of 800 times, it makes it possible to detect and quantify changes in the epithelial layers and sub-basal nerve plexus.
| Study group | Role | What they receive |
|---|---|---|
| Lotemax | Active comparator | Lotemax (loteprednol etabonate) 0.5% is a prescription-only, preserved ophthalmic suspension supplied by Bausch \& Lomb, Inc. Lotemax (loteprednol etabonate) 0.5% has been approved by the FDA for treatment of ocular inflammation with a maximum dosing frequency of 24 drops per eye per day. It is a C-20 ester-based corticosteroid, with a potent anti-inflammatory efficacy, but decreased impact on intraocular pressure (IOP) compared to other corticosteroids, which may increase IOP. The medication will be applied topically to both eyes for 6 weeks with the following regimen: four times a day for 2 weeks, twice daily for 2 weeks, and once daily for 2 weeks. Receives: Drug: Lotemax; Diagnostic Test: In Vivo Confocal Microscopy (IVCM) |
| Soothe Tired Eyes Lubricant Eye Drop (Artificial Tears) | Active comparator | Soothe Tired Eyes Lubricant Eye Drop (Bausch \& Lomb Inc.) is a preserved artificial tear which is used to relieve the dryness of the eye and to prevent further irritation. Its active ingredient is glycerin 1%. The artificial tear will be applied topically to both eyes for 6 weeks with the following regimen: four times a day for 2 weeks, twice daily for 2 weeks, and once daily for 2 weeks. Receives: Drug: Soothe Tired Eyes Lubricant Eye Drop (Artificial Tears); Diagnostic Test: In Vivo Confocal Microscopy (IVCM) |
What is being measured
The primary outcome is the main question the study is designed to answer.
IVCM for Density of Corneal Immune Dendritiform Cells
Density (in cells/mm^2) of Corneal Immune Dendritiform Cells
Measured: 2 Weeks
IVCM for Density of Corneal Immune Dendritiform Cells
Density (in cells/mm^2) of corneal immune dendritiform cells
Measured: 6 Weeks
IVCM for Corneal Immune Dendritiform Cell (DC) Morphology
Morphology (in cells/mm^2) of Corneal Immune Dendritiform Cells
Measured: 2 Weeks
IVCM for Corneal Immune Dendritiform Cell (DC) Morphology
Morphology (in cells/mm^2) of Corneal Immune Dendritiform Cells
Measured: 6 Weeks
Secondary outcomes (12)
Ocular Signs: Corneal Epitheliopathy
Corneal Fluorescein Staining Using the National Eye Institute (NEI) Grading Scheme Minimum score-0 Maximum score-15 Higher score means worse outcome
Measured: 2 Weeks
Ocular Signs: Corneal Epitheliopathy
Corneal Fluorescein Staining Using the National Eye Institute (NEI) Grading Scheme Minimum score-0 Maximum score-15 Higher score means worse outcome
Measured: 6 Weeks
Ocular Signs: Conjunctival Epitheliopathy
Conjunctival Lissamine Green Staining Using National Eye Institute (NEI) Grading Scheme Minimum score-0 Maximum score-18 Higher score means worse outcome
Measured: 2 Weeks
Ocular Signs: Conjunctival Epitheliopathy
Conjunctival Lissamine Green Staining Using National Eye Institute (NEI) Grading Scheme Minimum score-0 Maximum score-18 Higher score means worse outcome
Measured: 6 Weeks
Ocular Symptoms: Ocular Surface Disease Index (OSDI) Questionnaire
Total Score of the Ocular Surface Disease Index (OSDI) Questionnaire Minimum score- 0 Maximum score-100 Higher score means worse outcome
Measured: 2 Weeks
Ocular Symptoms: Ocular Surface Disease Index (OSDI) Questionnaire
Total Score of the Ocular Surface Disease Index (OSDI) Questionnaire Minimum score- 0 Maximum score-100 Higher score means worse outcome
Measured: 6 Weeks
Ocular Signs: Intraocular Pressure (IOP) by Measure of Applanation Tonometry
Intraocular Pressure (IOP) will be measured via Applanation and the result will have these units: mmHg
Measured: 2 Weeks
Ocular Signs: Intraocular Pressure (IOP) by Measure of Applanation Tonometry
Intraocular Pressure (IOP) will be measured via Applanation and the result will have these units: mmHg
Measured: 6 Weeks
Ocular Signs: Tear Break Up Time (TBUT)
Tear Break Up Time (TBUT) will be recorded in seconds
Measured: 2 Weeks
Ocular Signs: Tear Break Up Time (TBUT)
Tear Break Up Time (TBUT) will be recorded in seconds
Measured: 6 Weeks
Ocular Signs: Schirmer's Test With Anesthesia
The Schirmer's Test (performed using Anesthesia) will be measured in mm.
Measured: 2 Weeks
Ocular Signs: Schirmer's Test With Anesthesia
The Schirmer's Test (performed using Anesthesia) will be measured in mm.
Measured: 6 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2014 (estimated)
- Study startFeb 2014
- Primary completionApr 2017
- Study completion28 Jan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 37 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, Tufts Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02120079
- Sponsor's protocol ID
- 13-150H
- Status last verified
- Jun 2024
- First submitted
- 12 Feb 2014
- Last updated
- 26 Jun 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Utility of in Vivo Confocal Microscopy (IVCM) to Assess Cellular Response and Efficacy of Long-term Topical Steroid Treatment in Patients With Dry Eye Disease (DED)
- ClinicalTrials.gov ID
- NCT02120079
- Acronym / sponsor ID
- 13-150H
- Conditions
- Dry Eye Disease
- Keywords
- Dry Eye
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- Tufts Medical CenterUniversity, hospital or other
- Study start
- Feb 2014
- Primary completion
- Apr 2017 (actual)
- Study completion
- 28 Jan 2018 (actual)
- First posted
- 22 Apr 2014 (estimated)
- Results
- Posted 23 Mar 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This research study is looking to see if in vivo confocal microscopy (IVCM) imaging can be used to confirm clinical findings (which are noted by the doctor during an eye exam) and measure the immune response to the inflammation in the subject's cornea (the front part of the eyeball).
Additionally, this study is trying to determine the effectiveness of two eye-drops, Lotemax and artificial tears, in treating the inflammation associated with DED by measuring changes in immune cells with IVCM imaging. The subject will be treated with either Lotemax (loteprednol) or artificial tears (a lubricating eye drop with no medication). Lotemax is an FDA-approved steroid eye-drop that is often used to treat inflammation associated with DED. Artificial tears are approved by the FDA for treatment of dryness associated with DED.
Thus, this study is designed to determine the effects of the administration of a topical steroid, Lotemax, over a treatment period of 6 weeks, using novel methods of detecting efficacy. In order to achieve the aforementioned goal, subjects will be prospectively randomized to one of two treatment arms - Lotemax or artificial tear. Both groups will follow the same study schedule.
Detailed description
IVCM is a non-invasive imaging technique that images the cornea at a cellular level with 800x magnification, using a scanning laser. The laser is used to map the cornea, and will not damage or harm the subject's eye. Studies have shown that IVCM can be used to study cells and nerves within the cornea, providing a better understanding of how the cornea reacts to irritants. IVCM has recently been used by the investigator to assess the extent of eye inflammation in cases of dry eye patients.
Current steroid therapy in dry eye disease (DED) is comprised of a 2 week duration of pulse therapy, administered twice daily (to avoid adverse effects associated with long-term steroid use). This time frame is often too short to meaningfully resolve the inflammation associated with DED. DED often occurs when there is a decrease in the eye's tear production or if there is an increase in the evaporation of the tear film (a thin layer of tears that keep the eye moist). Eye irritation and inflammation (swelling) is often associated with DED because the surface of the eye is unable to maintain a normal level of moisture.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lotemax | Active comparator | Drug: Lotemax, Diagnostic Test: In Vivo Confocal Microscopy (IVCM)Lotemax (loteprednol etabonate) 0.5% is a prescription-only, preserved ophthalmic suspension supplied by Bausch \& Lomb, Inc. Lotemax (loteprednol etabonate) 0.5% has been approved by the FDA for treatment of ocular inflammation with a maximum dosing frequency of 24 drops per eye per day. It is a C-20 ester-based corticosteroid, with a potent anti-inflammatory efficacy, but decreased impact on intraocular pressure (IOP) compared to other corticosteroids, which may increase IOP. The medication will be applied topically to both eyes for 6 weeks with the following regimen: four times a day for 2 weeks, twice daily for 2 weeks, and once daily for 2 weeks. |
| Soothe Tired Eyes Lubricant Eye Drop (Artificial Tears) | Active comparator | Drug: Soothe Tired Eyes Lubricant Eye Drop (Artificial Tears), Diagnostic Test: In Vivo Confocal Microscopy (IVCM)Soothe Tired Eyes Lubricant Eye Drop (Bausch \& Lomb Inc.) is a preserved artificial tear which is used to relieve the dryness of the eye and to prevent further irritation. Its active ingredient is glycerin 1%. The artificial tear will be applied topically to both eyes for 6 weeks with the following regimen: four times a day for 2 weeks, twice daily for 2 weeks, and once daily for 2 weeks. |
Who may qualify
- Ages
- 18 to 89 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Age 18-89 years.
- Willing and able to provide written informed consent.
- Willing and able to comply with study assessments for the full duration of the study.
- In good stable overall health.
- Corneal dendritiform cell count by confocal microscopy of >=75/mm2 (13 immune cells per image)
Key exclusion criteria (11 listed)
- Central corneal subbasal dendritic cell count by in vivo confocal microscopy of <75/mm2 in both eyes
- Active ocular allergies
- Active allergies to steroids, aminoglycosides, or benzalkonium chloride (BAK)
- History of contact lens wear within 3 months before enrollment.
- Intraocular surgery or ocular laser surgery within 3 months before enrollment.
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 |
|---|---|---|
| LotemaxAlso: Lotemax (loteprednol etabonate) 0.5%Lotemax (loteprednol etabonate) 0.5% will be applied topically to both eyes for 6 weeks with the following regimen: four times a day for 2 weeks, twice daily for 2 weeks, and once daily for 2 weeks. | Drug | Lotemax |
| Soothe Tired Eyes Lubricant Eye Drop (Artificial Tears)Also: Soothe Tired Eyes Lubricant Eye Drop (Bausch & Lomb Inc.)Soothe Tired Eyes Lubricant Eye Drop will be applied topically to both eyes for 6 weeks with the following regimen: four times a day for 2 weeks, twice daily for 2 weeks, and once daily for 2 weeks. | Drug | Soothe Tired Eyes Lubricant Eye Drop (Artificial Tears) |
| In Vivo Confocal Microscopy (IVCM)In vivo confocal microscopy (IVCM) is a new imaging method, which allows visualization of the corneal structures at the cellular level. With a magnification of 800 times, it makes it possible to detect and quantify changes in the epithelial layers and sub-basal nerve plexus. | Diagnostic test | Lotemax, Soothe Tired Eyes Lubricant Eye Drop (Artificial Tears) |
Primary outcome
IVCM for Density of Corneal Immune Dendritiform Cells
Time frame: 2 Weeks
Density (in cells/mm^2) of Corneal Immune Dendritiform Cells
IVCM for Density of Corneal Immune Dendritiform Cells
Time frame: 6 Weeks
Density (in cells/mm^2) of corneal immune dendritiform cells
IVCM for Corneal Immune Dendritiform Cell (DC) Morphology
Time frame: 2 Weeks
Morphology (in cells/mm^2) of Corneal Immune Dendritiform Cells
IVCM for Corneal Immune Dendritiform Cell (DC) Morphology
Time frame: 6 Weeks
Morphology (in cells/mm^2) of Corneal Immune Dendritiform Cells
12 secondary outcomes
Ocular Signs: Corneal Epitheliopathy
Time frame: 2 Weeks
Ocular Signs: Corneal Epitheliopathy
Time frame: 6 Weeks
Ocular Signs: Conjunctival Epitheliopathy
Time frame: 2 Weeks
Ocular Signs: Conjunctival Epitheliopathy
Time frame: 6 Weeks
Ocular Symptoms: Ocular Surface Disease Index (OSDI) Questionnaire
Time frame: 2 Weeks
Ocular Symptoms: Ocular Surface Disease Index (OSDI) Questionnaire
Time frame: 6 Weeks
Ocular Signs: Intraocular Pressure (IOP) by Measure of Applanation Tonometry
Time frame: 2 Weeks
Ocular Signs: Intraocular Pressure (IOP) by Measure of Applanation Tonometry
Time frame: 6 Weeks
Ocular Signs: Tear Break Up Time (TBUT)
Time frame: 2 Weeks
Ocular Signs: Tear Break Up Time (TBUT)
Time frame: 6 Weeks
Ocular Signs: Schirmer's Test With Anesthesia
Time frame: 2 Weeks
Ocular Signs: Schirmer's Test With Anesthesia
Time frame: 6 Weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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
Tufts Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Lotemax, Soothe Tired Eyes Lubricant Eye Drop (Artificial Tears) and In Vivo Confocal Microscopy (IVCM) in people with 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 12 inclusion and 11 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 26 Jun 2024. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 23 Mar 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
IVCM for Density of Corneal Immune Dendritiform Cells (time frame: 2 Weeks). The study lists 4 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 26 Jun 2024.