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

Dry Eye Syndromes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01072526
• Other study ID #: LNJ-1
• Secondary ID: IRB 1095817
• Status: Recruiting
• Phase: Phase 2
• First received: December 31, 2007
• Last updated: February 19, 2010
• Start date: December 2007
• Est. completion date: September 2008

Study information

• Verified date: February 2010
• Source: University of Missouri-Columbia
• Contact: Lenworth N Johnson, MD
• Phone: 573-882-8470
• Email: johnsonln[@]health.missouri.edu
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: September 2008
• Est. primary completion date: September 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Dry Eye Syndromes
• Eye Diseases
• Keratoconjunctivitis Sicca

Intervention

Drug:
• euphrasia based homeopathic therapy and cyclosporin
ophthalmic solution; 1 drop both eyes twice daily
• cyclosporin solution
ophthalmic solution; 1 drop both eyes twice daily

Locations

Country	Name	City	State
United States	University of Missouri-Columbia, Mason Eye Institute	Columbia	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
University of Missouri-Columbia

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ocular Surface Disease Index OSDI		baseline, 6 weeks	No
Secondary	Tear film breakup time		Baseline, 6 weeks	No
Secondary	Fluorescein staining		Baseline, 6 weeks	No
Secondary	Schirmer tear test with anesthesia		Baseline, 6 weeks	No