Clinical trial NCT01072526: Pilot Study of a Homeopathic Therapy in Combination With Cyclosporin (Restasis) 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 type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Dry Eye Syndromes
Keywords: Dry Eye Syndromes
Lacrimal Apparatus Diseases
Lead sponsor: University of Missouri-Columbia
Sponsor class: OTHER
First posted: 2010-02-22
Enrollment: 7
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

Eligibility 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

Primary outcomes:
measure: Change in Ocular Surface Disease Index (OSDI)
timeFrame: Start of treatment, 6 weeks
Secondary outcomes:
measure: Change in Tear Film Breakup Time
timeFrame: Baseline, 6 weeks
measure: Change in Fluorescein Staining Scale
timeFrame: Baseline, 6 weeks
measure: Change in Schirmer Tear Test With Anesthesia Result
timeFrame: Baseline, 6 weeks
Other outcomes:
measure: Change in Severity of Ocular Discomfort
timeFrame: Baseline, 6 weeks
Locations:
city: Columbia
country: United States
facility: University of Missouri-Columbia, Mason Eye Institute
state: Missouri
Study officials:
affiliation: University of Missouri-Columbia
name: Lenworth N Johnson, MD
role: PRINCIPAL_INVESTIGATOR
References: