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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2010 by University of Missouri-Columbia.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
University of Missouri-Columbia
ClinicalTrials.gov Identifier:
NCT01072526
First received: December 31, 2007
Last updated: February 19, 2010
Last verified: February 2010
  Purpose

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 Intervention Phase
Dry Eye Syndromes
Drug: euphrasia based homeopathic therapy and cyclosporin
Drug: cyclosporin solution
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:


Further study details as provided by University of Missouri-Columbia:

Primary Outcome Measures:
  • Ocular Surface Disease Index OSDI [ Time Frame: baseline, 6 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Tear film breakup time [ Time Frame: Baseline, 6 weeks ] [ Designated as safety issue: No ]
  • Fluorescein staining [ Time Frame: Baseline, 6 weeks ] [ Designated as safety issue: No ]
  • Schirmer tear test with anesthesia [ Time Frame: Baseline, 6 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 20
Study Start Date: December 2007
Estimated Study Completion Date: September 2008
Estimated Primary Completion Date: September 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
Euphrasia based homeopathic therapy in combination with cyclosporin (Restasis)
Drug: euphrasia based homeopathic therapy and cyclosporin
ophthalmic solution; 1 drop both eyes twice daily
Placebo Comparator: 2
Placebo in combination with cyclosporin (Restasis)
Drug: cyclosporin solution
ophthalmic solution; 1 drop both eyes twice daily

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

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01072526

Contacts
Contact: Lenworth N Johnson, MD 573-882-8470 johnsonln@health.missouri.edu
Contact: Tara G Missoi, MD 573-882-8470 missoit@health.missouri.edu

Locations
United States, Missouri
University of Missouri-Columbia, Mason Eye Institute Recruiting
Columbia, Missouri, United States, 65212
Contact: Lenworth N Johnson, MD    573-882-8470    johnsonln@health.missouri.edu   
Contact: Tara G Missoi, MD    573-882-8470    missoit@health.missouri.edu   
Principal Investigator: Lenworth N Johnson, MD         
Sub-Investigator: Tara G Missoi, MD         
Sponsors and Collaborators
University of Missouri-Columbia
Investigators
Principal Investigator: Lenworth N Johnson, MD University of Missouri-Columbia
  More Information

No publications provided

Responsible Party: Lenworth Johnson, MD, Mason Eye Institute
ClinicalTrials.gov Identifier: NCT01072526     History of Changes
Other Study ID Numbers: LNJ-1, IRB 1095817
Study First Received: December 31, 2007
Last Updated: February 19, 2010
Health Authority: United States: Institutional Review Board

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

Additional relevant MeSH terms:
Dry Eye Syndromes
Keratoconjunctivitis Sicca
Eye Diseases
Lacrimal Apparatus Diseases
Keratoconjunctivitis
Conjunctivitis
Conjunctival Diseases
Keratitis
Corneal Diseases
Cyclosporins
Cyclosporine
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antifungal Agents
Anti-Infective Agents
Therapeutic Uses
Dermatologic Agents
Antirheumatic Agents

ClinicalTrials.gov processed this record on July 29, 2014