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

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ClinicalTrials.gov 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
Sponsor:
Information provided by (Responsible Party):
University of Missouri-Columbia

Tracking Information
First Submitted Date  ICMJE December 31, 2007
First Posted Date  ICMJE February 22, 2010
Results First Submitted Date  ICMJE September 4, 2014
Results First Posted Date  ICMJE January 12, 2017
Last Update Posted Date January 12, 2017
Study Start Date  ICMJE December 2007
Actual Primary Completion Date August 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 15, 2016)
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 Measures  ICMJE
 (submitted: February 19, 2010)
Ocular Surface Disease Index OSDI [ Time Frame: baseline, 6 weeks ]
Change History Complete list of historical versions of study NCT01072526 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: November 15, 2016)
  • 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 Measures  ICMJE
 (submitted: February 19, 2010)
  • 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 ]
Current Other Pre-specified Outcome Measures
 (submitted: November 15, 2016)
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.
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Pilot Study of a Homeopathic Therapy in Combination With Cyclosporin (Restasis) in the Treatment of Dry Eye Disease
Official Title  ICMJE 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 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).

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Dry Eye Syndromes
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • Active Comparator: Intervention
    Subjects will receive Euphrasia-based homeopathic therapy (Artificial Tears) in combination with cyclosporin solution (Restasis) .
    Interventions:
    • Drug: Euphrasia-based homeopathic therapy
    • Drug: Cyclosporin solution
  • Placebo Comparator: Control
    Subjects will receive placebo in combination with cyclosporin solution (Restasis) .
    Intervention: Drug: Cyclosporin solution
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: November 15, 2016)
7
Original Estimated Enrollment  ICMJE
 (submitted: February 19, 2010)
20
Actual Study Completion Date  ICMJE August 2010
Actual Primary Completion Date August 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 21 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01072526
Other Study ID Numbers  ICMJE LNJ-1
IRB 1095817 ( Other Identifier: University of Missouri )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University of Missouri-Columbia
Study Sponsor  ICMJE University of Missouri-Columbia
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Lenworth N Johnson, MD University of Missouri-Columbia
PRS Account University of Missouri-Columbia
Verification Date November 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP