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

Study Overview
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Brief Summary
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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
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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).

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

Conditions
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Dry Eye Syndromes

Intervention / Treatment
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* Drug: Euphrasia-based homeopathic therapy
* Drug: Cyclosporin solution


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Intervention<br>Subjects will receive Euphrasia-based homeopathic therapy (Artificial Tears) in combination with cyclosporin solution (Restasis) . | Drug: Euphrasia-based homeopathic therapy<br>* ophthalmic solution; 1 drop both eyes twice daily<br>* Other names: Artificial Tears;Drug: Cyclosporin solution<br>* Cyclosporin solution; 1 drop both eyes twice daily<br>* Other names: Restasis;|
| Placebo Comparator: Control<br>Subjects will receive placebo in combination with cyclosporin solution (Restasis) . | Drug: Cyclosporin solution<br>* Cyclosporin solution; 1 drop both eyes twice daily<br>* Other names: Restasis;|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Tear Film Breakup Time | 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. | Baseline, 6 weeks | 
| Change in Fluorescein Staining Scale | Demonstrates abrasions on cornea and extent of disease. Graded on a scale of 0-5 with 5 being the worst score. | Baseline, 6 weeks | 
| Change in Schirmer Tear Test With Anesthesia Result | 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. | Baseline, 6 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Dry Eye Syndromes, Lacrimal Apparatus Diseases