Pilot Study of a Homeopathic Therapy in Combination With Cyclosporin (Restasis) in the Treatment of Dry Eye Disease

Phase 2

Terminated

Interventions: Drug: Cyclosporin solution
Drug: Euphrasia-based homeopathic therapy

Brief Summary: 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.

Detailed Description: 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).

Recruitment & Eligibility

Inclusion Criteria

diagnosis of moderate to severe dry eye syndrome with or without Sjögren's syndrome
receiving treatment with topical cyclosporine (Restasis)
experience one or more moderate dry eye-related symptoms, including dryness, foreign body sensation, burning, blurred vision, photophobia, and soreness or pain

Exclusion Criteria

history of ocular disorder including non-dry eye ocular inflammation, glaucoma, contact lens use
trauma or surgery, including punctal plug insertion within the prior 3 months
any uncontrolled systemic disease or significant illness
use of topical ophthalmic medications that could affect dry eye syndrome
pregnancy, lactation, or considering a pregnancy

Arm && Interventions

Group	Intervention	Description
Control	Cyclosporin solution	Subjects will receive placebo in combination with cyclosporin solution (Restasis) .
Intervention	Euphrasia-based homeopathic therapy	Subjects will receive Euphrasia-based homeopathic therapy (Artificial Tears) in combination with cyclosporin solution (Restasis) .
Intervention	Cyclosporin solution	Subjects will receive Euphrasia-based homeopathic therapy (Artificial Tears) in combination with cyclosporin solution (Restasis) .

Primary Outcome Measures

Name	Time	Method
Change in Ocular Surface Disease Index (OSDI)	Start of treatment, 6 weeks	Measures dry eye disease and effect on vision-related function. Measured on a scale of 0-100, with higher scores indicating greater disability.

Secondary Outcome Measures

Name	Time	Method
Change in Fluorescein Staining Scale	Baseline, 6 weeks	Demonstrates abrasions on cornea and extent of disease. Graded on a scale of 0-5 with 5 being the worst score.
Change in Tear Film Breakup Time	Baseline, 6 weeks	Interval between last blink and break-up of tear film, measured in seconds. Less than 10 seconds = dry eye disease; lower score indicates worse disease.
Change in Schirmer Tear Test With Anesthesia Result	Baseline, 6 weeks	Assesses how quickly tears are produced, measured in millimeters (mm) on blotting paper. Greater than 15 mm indicates normal tear production; lower measurement indicates presence of dry eye disease.