Dry Eye Syndromes Clinical Trial
Official title:
Pilot Study of a Homeopathic Therapy in Combination With Cyclosporin (Restasis) in the Treatment of Dry Eye Disease
The purpose of this study is to determine whether a homeopathic therapy in combination with cyclosporin (Restasis) is more effective than cyclosporin (Restasis) alone in the treatment of dry eye disease.
Dry eye disease affects millions of people world-wide, and presents with symptoms of blurred
vision, discharge from the eyes, eye discomfort, burning, redness, sandy and gritty feeling
in the eyes, and sensitivity to light. Topical eye drops for eye lubrication (i.e.,
artificial tear solutions) and controlling ocular inflammation through the use of topical
immunomodulatory agents (i.e., cyclosporine [Restasis]) have been shown to be effective for
treating dry eye syndrome, but are not curative. Recently, we have evaluated a few patients
who had discontinued using Restasis as they had obtained better relief of their dry eye
symptoms with a homeopathic therapy.
Potential participants will undergo an eye examination consisting of medical history and
physical examination (i.e., visual acuity, pupillary exam, examination of the lids,
slit-lamp examination of the conjunctiva, cornea, anterior chamber, iris, and lens, and
funduscopic examination). Participants qualifying for the study will then stop all eye
medications and will use a common artificial tear solution for 2 weeks prior to the baseline
examination. We will evaluate 4 measures of dry eyes at baseline and after 6 weeks of
therapy: 1) tear film to break-up; 2) staining of the cornea by fluorescein stain; 3)
measurement of tear production over 5 minutes by Schirmer's test; and 4) the Ocular Surface
Disease Index (OSDI).
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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