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CompletedNCT02120079Updated Jun 26, 2024Results posted

The Utility of IVCM to Assess Cellular Response and Efficacy of Long-term Topical Steroid Treatment in Patients With DED

A Phase 4 interventional study of Lotemax and Soothe Tired Eyes Lubricant Eye Drop (Artificial Tears) in Dry Eye Disease, sponsored by Tufts Medical Center. Completed at 1 site in United States. Open to participants aged 18 Years to 89 Years. Per ClinicalTrials.gov, last updated 2024-06-26.

Sponsored by Tufts Medical Center · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
37
Allocation
Randomized
Ages
18 Years to 89 Years
Sex
All
01

Study 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).

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.

02

Conditions studied

  • Dry Eye Disease

Keywords

  • Dry Eye
03

In context

Dry Eye Syndromes

1,292 studies on the registry are indexed under Dry Eye Syndromes; 191 are open to participants now.

This study's enrollment of 37 is below the median of 60 across 1,077 interventional studies indexed under Dry Eye Syndromes.

Browse Dry Eye Syndromes studies →

Lead sponsor

Tufts Medical Center is the lead sponsor of 194 studies on the registry; 28 are open to participants now.

Of its 30 completed or terminated interventional studies of FDA-regulated products, 16 (53%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 89 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 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:
  • 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

Exclusion criteria

Exclusion Criteria:

  • 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.
  • 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.
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
37 participants (actual)

Study arms

  • Active comparator
    Lotemax

    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.

    Drug: Lotemax · Diagnostic Test: In Vivo Confocal Microscopy (IVCM)

  • Active comparator
    Soothe Tired Eyes Lubricant Eye Drop (Artificial Tears)

    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.

    Drug: Soothe Tired Eyes Lubricant Eye Drop (Artificial Tears) · Diagnostic Test: In Vivo Confocal Microscopy (IVCM)

Interventions

  • DrugLotemax

    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.

    Also known as: Lotemax (loteprednol etabonate) 0.5%

  • DrugSoothe Tired Eyes Lubricant Eye Drop (Artificial Tears)

    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.

    Also known as: Soothe Tired Eyes Lubricant Eye Drop (Bausch & Lomb Inc.)

  • Diagnostic testIn 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.

06

What researchers measure

Primary outcomes

  1. IVCM for Density of Corneal Immune Dendritiform Cells

    Density (in cells/mm\^2) of Corneal Immune Dendritiform Cells

    Time frame: 2 Weeks

  2. IVCM for Density of Corneal Immune Dendritiform Cells

    Density (in cells/mm\^2) of corneal immune dendritiform cells

    Time frame: 6 Weeks

  3. IVCM for Corneal Immune Dendritiform Cell (DC) Morphology

    Morphology (in cells/mm\^2) of Corneal Immune Dendritiform Cells

    Time frame: 2 Weeks

  4. IVCM for Corneal Immune Dendritiform Cell (DC) Morphology

    Morphology (in cells/mm\^2) of Corneal Immune Dendritiform Cells

    Time frame: 6 Weeks

Secondary outcomes

  1. 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

    Time frame: 2 Weeks

  2. 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

    Time frame: 6 Weeks

  3. 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

    Time frame: 2 Weeks

  4. 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

    Time frame: 6 Weeks

  5. 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

    Time frame: 2 Weeks

  6. 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

    Time frame: 6 Weeks

  7. 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

    Time frame: 2 Weeks

  8. 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

    Time frame: 6 Weeks

  9. Ocular Signs: Tear Break Up Time (TBUT)

    Tear Break Up Time (TBUT) will be recorded in seconds

    Time frame: 2 Weeks

  10. Ocular Signs: Tear Break Up Time (TBUT)

    Tear Break Up Time (TBUT) will be recorded in seconds

    Time frame: 6 Weeks

  11. Ocular Signs: Schirmer's Test With Anesthesia

    The Schirmer's Test (performed using Anesthesia) will be measured in mm.

    Time frame: 2 Weeks

  12. Ocular Signs: Schirmer's Test With Anesthesia

    The Schirmer's Test (performed using Anesthesia) will be measured in mm.

    Time frame: 6 Weeks

07

Results

Posted Mar 23, 2022

Participant flow

Baseline
Participant flow — Baseline
MilestoneLotemaxSoothe Tired Eyes Lubricant Eye Drop (Artificial Tears)
Started1720
Completed1720
Not completed00
2 Weeks
Participant flow — 2 Weeks
MilestoneLotemaxSoothe Tired Eyes Lubricant Eye Drop (Artificial Tears)
Started1720
Completed1720
Not completed00
6 Weeks
Participant flow — 6 Weeks
MilestoneLotemaxSoothe Tired Eyes Lubricant Eye Drop (Artificial Tears)
Started1720
Completed1720
Not completed00

Outcome measures

PrimaryIVCM for Density of Corneal Immune Dendritiform Cells

Density (in cells/mm\^2) of Corneal Immune Dendritiform Cells

Time frame:
2 Weeks
Reported as:
Mean · cells/mm^2
IVCM for Density of Corneal Immune Dendritiform Cells
cells/mm^2LotemaxSoothe Tired Eyes Lubricant Eye Drop (Artificial Tears)
IVCM for Density of Corneal Immune Dendritiform Cells9.47 ± 5.1328.60 ± 26.09
PrimaryIVCM for Density of Corneal Immune Dendritiform Cells

Density (in cells/mm\^2) of corneal immune dendritiform cells

Time frame:
6 Weeks
Reported as:
Mean · cells/mm^2
IVCM for Density of Corneal Immune Dendritiform Cells
cells/mm^2LotemaxSoothe Tired Eyes Lubricant Eye Drop (Artificial Tears)
IVCM for Density of Corneal Immune Dendritiform Cells9.80 ± 5.1034.03 ± 31.92
PrimaryIVCM for Corneal Immune Dendritiform Cell (DC) Morphology

Morphology (in cells/mm\^2) of Corneal Immune Dendritiform Cells

Time frame:
2 Weeks
Reported as:
Mean · cells/mm^2
IVCM for Corneal Immune Dendritiform Cell (DC) Morphology
cells/mm^2LotemaxSoothe Tired Eyes Lubricant Eye Drop (Artificial Tears)
IVCM for Corneal Immune Dendritiform Cell (DC) Morphology109.50 ± 40.5697.95 ± 30.92
PrimaryIVCM for Corneal Immune Dendritiform Cell (DC) Morphology

Morphology (in cells/mm\^2) of Corneal Immune Dendritiform Cells

Time frame:
6 Weeks
Reported as:
Mean · Cells/mm^2
IVCM for Corneal Immune Dendritiform Cell (DC) Morphology
Cells/mm^2LotemaxSoothe Tired Eyes Lubricant Eye Drop (Artificial Tears)
IVCM for Corneal Immune Dendritiform Cell (DC) Morphology102.31 ± 26.2589.34 ± 24.73
SecondaryOcular 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

Time frame:
2 Weeks
Reported as:
Mean · Score
Ocular Signs: Corneal Epitheliopathy
ScoreLotemaxSoothe Tired Eyes Lubricant Eye Drop (Artificial Tears)
Ocular Signs: Corneal Epitheliopathy1.86 ± 2.123.18 ± 2.55
SecondaryOcular 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

Time frame:
6 Weeks
Reported as:
Mean · Score
Ocular Signs: Corneal Epitheliopathy
ScoreLotemaxSoothe Tired Eyes Lubricant Eye Drop (Artificial Tears)
Ocular Signs: Corneal Epitheliopathy2.00 ± 1.983.59 ± 2.75
SecondaryOcular 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

Time frame:
2 Weeks
Reported as:
Mean · Score
Ocular Signs: Conjunctival Epitheliopathy
ScoreLotemaxSoothe Tired Eyes Lubricant Eye Drop (Artificial Tears)
Ocular Signs: Conjunctival Epitheliopathy3.79 ± 3.474.50 ± 4.13
SecondaryOcular 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

Time frame:
6 Weeks
Reported as:
Mean · Score
Ocular Signs: Conjunctival Epitheliopathy
ScoreLotemaxSoothe Tired Eyes Lubricant Eye Drop (Artificial Tears)
Ocular Signs: Conjunctival Epitheliopathy2.46 ± 1.863.44 ± 3.55
SecondaryOcular 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

Time frame:
2 Weeks
Reported as:
Mean · Score
Ocular Symptoms: Ocular Surface Disease Index (OSDI) Questionnaire
ScoreLotemaxSoothe Tired Eyes Lubricant Eye Drop (Artificial Tears)
Ocular Symptoms: Ocular Surface Disease Index (OSDI) Questionnaire47.25 ± 27.3633.16 ± 23.55
SecondaryOcular 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

Time frame:
6 Weeks
Reported as:
Mean · Score
Ocular Symptoms: Ocular Surface Disease Index (OSDI) Questionnaire
ScoreLotemaxSoothe Tired Eyes Lubricant Eye Drop (Artificial Tears)
Ocular Symptoms: Ocular Surface Disease Index (OSDI) Questionnaire46.63 ± 29.1536.04 ± 23.30
SecondaryOcular 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

Time frame:
2 Weeks
Reported as:
Mean · mmHg
Ocular Signs: Intraocular Pressure (IOP) by Measure of Applanation Tonometry
mmHgLotemaxSoothe Tired Eyes Lubricant Eye Drop (Artificial Tears)
Ocular Signs: Intraocular Pressure (IOP) by Measure of Applanation Tonometry15.52 ± 2.8714.50 ± 3.32
SecondaryOcular 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

Time frame:
6 Weeks
Reported as:
Mean · mmHg
Ocular Signs: Intraocular Pressure (IOP) by Measure of Applanation Tonometry
mmHgLotemaxSoothe Tired Eyes Lubricant Eye Drop (Artificial Tears)
Ocular Signs: Intraocular Pressure (IOP) by Measure of Applanation Tonometry16.88 ± 2.3013.76 ± 3.32
SecondaryOcular Signs: Tear Break Up Time (TBUT)

Tear Break Up Time (TBUT) will be recorded in seconds

Time frame:
2 Weeks
Reported as:
Mean · Seconds
Ocular Signs: Tear Break Up Time (TBUT)
SecondsLotemaxSoothe Tired Eyes Lubricant Eye Drop (Artificial Tears)
Ocular Signs: Tear Break Up Time (TBUT)5.20 ± 3.483.93 ± 1.91
SecondaryOcular Signs: Tear Break Up Time (TBUT)

Tear Break Up Time (TBUT) will be recorded in seconds

Time frame:
6 Weeks
Reported as:
Mean · Seconds
Ocular Signs: Tear Break Up Time (TBUT)
SecondsLotemaxSoothe Tired Eyes Lubricant Eye Drop (Artificial Tears)
Ocular Signs: Tear Break Up Time (TBUT)4.83 ± 3.683.44 ± 2.04
SecondaryOcular Signs: Schirmer's Test With Anesthesia

The Schirmer's Test (performed using Anesthesia) will be measured in mm.

Time frame:
2 Weeks
Reported as:
Mean · mm
Ocular Signs: Schirmer's Test With Anesthesia
mmLotemaxSoothe Tired Eyes Lubricant Eye Drop (Artificial Tears)
Ocular Signs: Schirmer's Test With Anesthesia7.98 ± 4.986.88 ± 5.92
SecondaryOcular Signs: Schirmer's Test With Anesthesia

The Schirmer's Test (performed using Anesthesia) will be measured in mm.

Time frame:
6 Weeks
Reported as:
Mean · mm
Ocular Signs: Schirmer's Test With Anesthesia
mmLotemaxSoothe Tired Eyes Lubricant Eye Drop (Artificial Tears)
Ocular Signs: Schirmer's Test With Anesthesia8.16 ± 4.788.18 ± 6.06

Adverse events

Collected over 6 Weeks. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Lotemax0/17 (0%)0/17 (0%)0/17 (0%)
Soothe Tired Eyes Lubricant Eye Drop (Artificial Tears)0/20 (0%)0/20 (0%)0/20 (0%)

Baseline characteristics

Age, Continuous
Age, Continuous(years)LotemaxSoothe Tired Eyes Lubricant Eye Drop (Artificial Tears)Total
Mean57.29 ± 12.6255.35 ± 15.7856.24 ± 14.25
Sex: Female, Male
Sex: Female, Male(Participants)LotemaxSoothe Tired Eyes Lubricant Eye Drop (Artificial Tears)Total
Female121729
Male538
Race and Ethnicity Not Collected
Race and Ethnicity Not Collected(Participants)LotemaxSoothe Tired Eyes Lubricant Eye Drop (Artificial Tears)Total
Count of participants——0
Corneal immune dendritiform cell (DC) density at Baseline
Corneal immune dendritiform cell (DC) density at Baseline(cells/mm^2)LotemaxSoothe Tired Eyes Lubricant Eye Drop (Artificial Tears)Total
Mean26.83 ± 14.9834.59 ± 29.1530.97 ± 23.76
Corneal immune dendritiform cell (DC) morphology at Baseline
Corneal immune dendritiform cell (DC) morphology at Baseline(cells/mm2)LotemaxSoothe Tired Eyes Lubricant Eye Drop (Artificial Tears)Total
Mean90.79 ± 16.6792.29 ± 23.8291.59 ± 20.64
Corneal fluorescein staining at Baseline
Corneal fluorescein staining at Baseline(Score)LotemaxSoothe Tired Eyes Lubricant Eye Drop (Artificial Tears)Total
Mean3.39 ± 2.504.06 ± 3.273.76 ± 2.94
Ocular Symptoms Disease Index (OSDI) at Baseline
Ocular Symptoms Disease Index (OSDI) at Baseline(Score)LotemaxSoothe Tired Eyes Lubricant Eye Drop (Artificial Tears)Total
Mean56.93 ± 29.3638.46 ± 20.3447.18 ± 26.35
Lissamine Green at Baseline
Lissamine Green at Baseline(Score)LotemaxSoothe Tired Eyes Lubricant Eye Drop (Artificial Tears)Total
Mean3.57 ± 2.715.74 ± 4.264.76 ± 3.78

3 further baseline measures are reported on the registry.

08

Study locations

1 site
  • Tufts Medical Center
    Boston, Massachusetts 02111, United States
09

References and documents

Study documents

  • Protocol and statistical analysis plan · Jan 13, 2017

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 26, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT02120079
Lead sponsor
Tufts Medical Center
Responsible party
Sponsor
First posted
Apr 22, 2014
Start date
Feb 2014
Primary completion
Apr 2017
Completion
Jan 28, 2018
Results posted
Mar 23, 2022
Last update
Jun 26, 2024

Study contacts

Pedram Hamrah, MD
principal investigator · Tufts Medical Center

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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