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

Condition(s) targeted: Dry Eye Syndromes

Intervention: euphrasia based homeopathic therapy and cyclosporin (Drug); cyclosporin solution (Drug)

Phase: Phase 2

Status: Recruiting

Sponsored by: University of Missouri-Columbia

Official(s) and/or principal investigator(s):
Lenworth N Johnson, MD, Principal Investigator, Affiliation: University of Missouri-Columbia

Overall contact:
Lenworth N Johnson, MD, Phone: 573-882-8470, Email: johnsonln@health.missouri.edu

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.

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

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: Ocular Surface Disease Index OSDI

Secondary outcome:

Tear film breakup time

Fluorescein staining

Schirmer tear test with anesthesia

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).

Minimum age: 21 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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

Lenworth N Johnson, MD, Phone: 573-882-8470, Email: johnsonln@health.missouri.edu

University of Missouri-Columbia, Mason Eye Institute, Columbia, Missouri 65212, United States; Recruiting
Lenworth N Johnson, MD, Phone: 573-882-8470, Email: johnsonln@health.missouri.edu
Tara G Missoi, MD, Phone: 573-882-8470, Email: missoit@health.missouri.edu
Lenworth N Johnson, MD, Principal Investigator
Tara G Missoi, MD, Sub-Investigator

Starting date: December 2007
Last updated: February 19, 2010