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

NCT02120079 | Completed Phase 4 Results

• 1 other identifier: 13-150H
• Study Type: interventional
• Target: 37
• Locations: 1 country
• Sites: 1

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.

Conditions

Dry Eye Disease

Keywords

Dry Eye

Outcome Measures

Primary Outcomes (4)

• IVCM for Density of Corneal Immune Dendritiform Cells

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

  2 Weeks

• IVCM for Density of Corneal Immune Dendritiform Cells

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

  6 Weeks

• IVCM for Corneal Immune Dendritiform Cell (DC) Morphology

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

  2 Weeks

• IVCM for Corneal Immune Dendritiform Cell (DC) Morphology

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

  6 Weeks

Secondary Outcomes (12)

• Ocular Signs: Corneal Epitheliopathy

  2 Weeks

• Ocular Signs: Corneal Epitheliopathy

  6 Weeks

• Ocular Signs: Conjunctival Epitheliopathy

  2 Weeks

• Ocular Signs: Conjunctival Epitheliopathy

  6 Weeks

• Ocular Symptoms: Ocular Surface Disease Index (OSDI) Questionnaire

  2 Weeks

Study Arms (2)

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.

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.

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

Interventions

Lotemax DRUG

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%

Lotemax

Soothe Tired Eyes Lubricant Eye Drop (Artificial Tears) DRUG

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.)

Soothe Tired Eyes Lubricant Eye Drop (Artificial Tears)

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.

Lotemax; Soothe Tired Eyes Lubricant Eye Drop (Artificial Tears)

Eligibility Criteria

• Age: 18 Years - 89 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tufts Medical Center: lead

Study Sites (1)

Tufts Medical Center

Boston, Massachusetts, 02111, United States

Location

MeSH Terms

Conditions

Dry Eye Syndromes

Interventions

Loteprednol Etabonate; Lubricant Eye Drops

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

Androstadienes; Androstenes; Androstanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Ophthalmic Solutions; Pharmaceutical Solutions; Solutions; Pharmaceutical Preparations; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses; Lubricants; Specialty Uses of Chemicals

Results Point of Contact

• Title: Dr. Pedram Hamrah
• Organization: Tufts Medical Center

phamrah@tuftsmedicalcenter.org

617-636-5321

Study Officials

• Pedram Hamrah, MD

  Tufts Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 12, 2014
• First Posted: April 22, 2014
• Study Start: February 1, 2014
• Primary Completion: April 1, 2017
• Study Completion: January 28, 2018
• Last Updated: June 26, 2024
• Results First Posted: March 23, 2022

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)