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

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

7 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-12-31

Study Completion Date

2010-08-31

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.

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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).

Conditions

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Dry Eye Syndromes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Intervention

Subjects will receive Euphrasia-based homeopathic therapy (Artificial Tears) in combination with cyclosporin solution (Restasis) .

Group Type ACTIVE_COMPARATOR

Euphrasia-based homeopathic therapy

Intervention Type DRUG

ophthalmic solution; 1 drop both eyes twice daily

Cyclosporin solution

Intervention Type DRUG

Cyclosporin solution; 1 drop both eyes twice daily

Control

Subjects will receive placebo in combination with cyclosporin solution (Restasis) .

Group Type PLACEBO_COMPARATOR

Cyclosporin solution

Intervention Type DRUG

Cyclosporin solution; 1 drop both eyes twice daily

Interventions

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Euphrasia-based homeopathic therapy

ophthalmic solution; 1 drop both eyes twice daily

Intervention Type DRUG

Cyclosporin solution

Cyclosporin solution; 1 drop both eyes twice daily

Intervention Type DRUG

Other Intervention Names

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Artificial Tears Restasis

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

Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No