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

• Status: Completed
• Trial end date: 2018-01-28
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Massachusetts Eye and Ear Infirmary; Tufts Medical Center
• Treatments: Loteprednol Etabonate; Lubricant Eye Drops; Ophthalmic Solutions; Polystyrene sulfonic acid; Tetrahydrozoline

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.