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

Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional

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

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 Summary:

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).


Sponsor: University of Missouri-Columbia

Current Primary Outcome: Change in Ocular Surface Disease Index (OSDI) [ Time Frame: Start of treatment, 6 weeks ]

Measures dry eye disease and effect on vision-related function. Measured on a scale of 0-100, with higher scores indicating greater disability.


Original Primary Outcome: Ocular Surface Disease Index OSDI [ Time Frame: baseline, 6 weeks ]

Current Secondary Outcome:

  • Change in Tear Film Breakup Time [ Time Frame: Baseline, 6 weeks ]
    Interval between last blink and break-up of tear film, measured in seconds. Less than 10 seconds = dry eye disease; lower score indicates worse disease.
  • Change in Fluorescein Staining Scale [ Time Frame: Baseline, 6 weeks ]
    Demonstrates abrasions on cornea and extent of disease. Graded on a scale of 0-5 with 5 being the worst score.
  • Change in Schirmer Tear Test With Anesthesia Result [ Time Frame: Baseline, 6 weeks ]
    Assesses how quickly tears are produced, measured in millimeters (mm) on blotting paper. Greater than 15 mm indicates normal tear production; lower measurement indicates presence of dry eye disease.


Original Secondary Outcome:

  • Tear film breakup time [ Time Frame: Baseline, 6 weeks ]
  • Fluorescein staining [ Time Frame: Baseline, 6 weeks ]
  • Schirmer tear test with anesthesia [ Time Frame: Baseline, 6 weeks ]


Information By: University of Missouri-Columbia

Dates:
Date Received: December 31, 2007
Date Started: December 2007
Date Completion:
Last Updated: November 15, 2016
Last Verified: November 2016