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

University of Missouri (MU)

Status and phase: Terminated; Phase 2

Conditions: Dry Eye Syndromes

Treatments: Drug: Cyclosporin solution; Drug: Euphrasia-based homeopathic therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT01072526

IRB 1095817 (Other Identifier)

LNJ-1

Details and patient eligibility

About

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.

Full 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).

Enrollment: 7 patients

Sex: All

Ages: 21+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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7 participants in 2 patient groups, including a placebo group

Intervention

Active Comparator group

Description:

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

Treatment:

Drug: Euphrasia-based homeopathic therapy

Drug: Cyclosporin solution

Control

Placebo Comparator group

Description:

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

Treatment:

Drug: Cyclosporin solution