Conditions: Dry Eye Syndromes
Keywords: Dry Eye Syndromes Lacrimal Apparatus Diseases
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 7
Healthy volunteers: no

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).

Arms:
arm 1: Subjects will receive Euphrasia-based homeopathic therapy (Artificial Tears) in combination with cyclosporin solution (Restasis) . arm 2: Subjects will receive placebo in combination with cyclosporin solution (Restasis) .

Interventions: intervention 1: Euphrasia-based homeopathic therapy intervention 2: Cyclosporin solution
Intervention descriptions: intervention 1: ophthalmic solution; 1 drop both eyes twice daily intervention 2: Cyclosporin solution; 1 drop both eyes twice daily

Protocol document: