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

• Status: Terminated
• Trial end date: 2010-08-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Missouri-Columbia
• Treatments: Cyclosporine; Cyclosporins; Lubricant Eye Drops; Ophthalmic Solutions; Pharmaceutical Solutions

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