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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01072526
Recruitment Status : Terminated (Study personnel left institution before study completion)
First Posted : February 22, 2010
Results First Posted : January 12, 2017
Last Update Posted : January 12, 2017
Information provided by (Responsible Party):
University of Missouri-Columbia

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.

Condition or disease Intervention/treatment Phase
Dry Eye Syndromes Drug: Euphrasia-based homeopathic therapy Drug: Cyclosporin solution Phase 2

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).

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 7 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Pilot Study of a Homeopathic Therapy in Combination With Cyclosporin (Restasis) in the Treatment of Dry Eye Disease
Study Start Date : December 2007
Actual Primary Completion Date : August 2010
Actual Study Completion Date : August 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eye Diseases Tears

Arm Intervention/treatment
Active Comparator: Intervention
Subjects will receive Euphrasia-based homeopathic therapy (Artificial Tears) in combination with cyclosporin solution (Restasis) .
Drug: Euphrasia-based homeopathic therapy
ophthalmic solution; 1 drop both eyes twice daily
Other Name: Artificial Tears

Drug: Cyclosporin solution
Cyclosporin solution; 1 drop both eyes twice daily
Other Name: Restasis

Placebo Comparator: Control
Subjects will receive placebo in combination with cyclosporin solution (Restasis) .
Drug: Cyclosporin solution
Cyclosporin solution; 1 drop both eyes twice daily
Other Name: Restasis

Primary Outcome Measures :
  1. 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.

Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

Other Outcome Measures:
  1. Change in Severity of Ocular Discomfort [ Time Frame: Baseline, 6 weeks ]
    This will be calculated using a composite score of the primary and secondary outcome measures.

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01072526

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United States, Missouri
University of Missouri-Columbia, Mason Eye Institute
Columbia, Missouri, United States, 65212
Sponsors and Collaborators
University of Missouri-Columbia
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Principal Investigator: Lenworth N Johnson, MD University of Missouri-Columbia

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Responsible Party: University of Missouri-Columbia Identifier: NCT01072526     History of Changes
Other Study ID Numbers: LNJ-1
IRB 1095817 ( Other Identifier: University of Missouri )
First Posted: February 22, 2010    Key Record Dates
Results First Posted: January 12, 2017
Last Update Posted: January 12, 2017
Last Verified: November 2016

Keywords provided by University of Missouri-Columbia:
Dry Eye Syndromes
Lacrimal Apparatus Diseases

Additional relevant MeSH terms:
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Keratoconjunctivitis Sicca
Dry Eye Syndromes
Eye Diseases
Conjunctival Diseases
Corneal Diseases
Lacrimal Apparatus Diseases
Pharmaceutical Solutions
Lubricant Eye Drops
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antifungal Agents
Anti-Infective Agents
Dermatologic Agents
Antirheumatic Agents
Calcineurin Inhibitors
Ophthalmic Solutions