Pilot Study of a Homeopathic Therapy in Combination With Cyclosporin (Restasis) in the Treatment of Dry Eye Disease
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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 |
- Ocular Surface Disease Index OSDI [ Time Frame: baseline, 6 weeks ] [ Designated as safety issue: No ]
- 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 |
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| Contact: Lenworth N Johnson, MD | 573-882-8470 | johnsonln@health.missouri.edu |
| Contact: Tara G Missoi, MD | 573-882-8470 | missoit@health.missouri.edu |
| 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 | |
| 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 May 19, 2013