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

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ClinicalTrials.gov Identifier: NCT02120079
Recruitment Status : Completed
First Posted : April 22, 2014
Last Update Posted : January 18, 2019
Sponsor:
Information provided by (Responsible Party):
Tufts Medical Center

Brief 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.


Condition or disease Intervention/treatment Phase
Dry Eye Disease Drug: Lotemax Drug: Soothe Tired Eyes Lubricant Eye Drop (Artificial Tears) Diagnostic Test: In Vivo Confocal Microscopy (IVCM) Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 41 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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)
Study Start Date : February 2014
Actual Primary Completion Date : April 2017
Actual Study Completion Date : January 28, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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
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.
Other Name: Lotemax (loteprednol etabonate) 0.5%

Diagnostic Test: 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.

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)
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.
Other Name: Soothe Tired Eyes Lubricant Eye Drop (Bausch & Lomb Inc.)

Diagnostic Test: 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.




Primary Outcome Measures :
  1. In Vivo Confocal Microscopy (IVCM) for determination of density of superficial corneal epithelial cells [ Time Frame: 6 Weeks ]
    density (in cells/mm2) of superficial corneal epithelial cells

  2. IVCM for determination of size of superficial corneal epithelial cells [ Time Frame: 6 Weeks ]
    size (in µm2) of superficial corneal epithelial cells

  3. IVCM for determination of hyperreflectivity of superficial corneal epithelial cells [ Time Frame: 6 Weeks ]
    hyperreflectivity (% of cells) of superficial corneal epithelial cells

  4. IVCM for density of corneal immune dendritiform cells [ Time Frame: 6 Weeks ]
    density (in cells/mm2) of corneal immune dendritiform cells

  5. IVCM for size of corneal immune dendritiform cells [ Time Frame: 6 Weeks ]
    size (in µm2) of corneal immune dendritiform cells

  6. IVCM for cell field of corneal immune dendritiform cells [ Time Frame: 6 Weeks ]
    cell field (in µm2) of corneal immune dendritiform cells

  7. IVCM for density of subbasal nerves [ Time Frame: 6 Weeks ]
    density (mm/mm2) of subbasal nerves

  8. IVCM for number of main nerves and branches of corneal subasal nerves [ Time Frame: 6 Weeks ]
    absolute number of main nerves and branches of corneal subasal nerves

  9. IVCM for length of main nerves and branches of corneal subasal nerves [ Time Frame: 6 Weeks ]
    length (in mm) of main nerves and branches of corneal subasal nerves


Secondary Outcome Measures :
  1. Ocular Signs: Corneal epitheliopathy [ Time Frame: 6 Weeks ]
    Corneal fluorescein staining using the NEI grading scheme

  2. Ocular Signs: Conjunctival epitheliopathy [ Time Frame: 6 Weeks ]
    Conjunctival lissamine green staining using NEI grading scheme

  3. Ocular Signs: Tear Break Up Time (TBUT) [ Time Frame: 6 Weeks ]
    seconds

  4. Ocular Signs: Schirmer's Test with Anesthesia [ Time Frame: 6 Weeks ]
    mm

  5. Ocular Signs: Intraocular pressure (IOP) by measure of applanation tonometry [ Time Frame: 6 Weeks ]
    mmHg

  6. Ocular Symptoms: Ocular Surface Disease Index (OSDI) questionnaire [ Time Frame: 6 Weeks ]
    total score of the OSDI questionnaire

  7. Ocular Symptoms: • Symptom Assessment iN Dry Eye (SANDE) questionnaire [ Time Frame: 6 Weeks ]
    total score of SANDE questionnaire



Information from the National Library of Medicine

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, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 89 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02120079


Locations
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United States, Massachusetts
Tufts Medical Center
Boston, Massachusetts, United States, 02111
Sponsors and Collaborators
Tufts Medical Center
Investigators
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Principal Investigator: Pedram Hamrah, MD Tufts Medical Center
  Study Documents (Full-Text)

Documents provided by Tufts Medical Center:
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Responsible Party: Tufts Medical Center
ClinicalTrials.gov Identifier: NCT02120079    
Obsolete Identifiers: NCT02106377
Other Study ID Numbers: 13-150H
First Posted: April 22, 2014    Key Record Dates
Last Update Posted: January 18, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Tufts Medical Center:
Dry Eye
Additional relevant MeSH terms:
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Keratoconjunctivitis Sicca
Dry Eye Syndromes
Eye Diseases
Keratoconjunctivitis
Conjunctivitis
Conjunctival Diseases
Keratitis
Corneal Diseases
Lacrimal Apparatus Diseases
Loteprednol Etabonate
Ophthalmic Solutions
Lubricant Eye Drops
Pharmaceutical Solutions
Anti-Allergic Agents