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

November 15, 2016 updated by: University of Missouri-Columbia
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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Actual)

7

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Missouri
      • Columbia, Missouri, United States, 65212
        • University of Missouri-Columbia, Mason Eye Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Intervention
Subjects will receive Euphrasia-based homeopathic therapy (Artificial Tears) in combination with cyclosporin solution (Restasis) .
Drug: Euphrasia-based homeopathic therapy
ophthalmic solution; 1 drop both eyes twice daily
Other Names:
  • Artificial Tears
Drug: Cyclosporin solution
Cyclosporin solution; 1 drop both eyes twice daily
Other Names:
  • Restasis
Placebo Comparator: Control
Subjects will receive placebo in combination with cyclosporin solution (Restasis) .
Drug: Cyclosporin solution
Cyclosporin solution; 1 drop both eyes twice daily
Other Names:
  • Restasis

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Start of treatment, 6 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline, 6 weeks
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.
Baseline, 6 weeks
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.
Baseline, 6 weeks

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline, 6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Missouri-Columbia

Investigators

  • Principal Investigator: Lenworth N Johnson, MD, University of Missouri-Columbia

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2007

Primary Completion (Actual)

August 1, 2010

Study Completion (Actual)

August 1, 2010

Study Registration Dates

First Submitted

December 31, 2007

First Submitted That Met QC Criteria

February 19, 2010

First Posted (Estimate)

February 22, 2010

Study Record Updates

Last Update Posted (Estimate)

January 12, 2017

Last Update Submitted That Met QC Criteria

November 15, 2016

Last Verified

November 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LNJ-1
  • IRB 1095817 (Other Identifier: University of Missouri)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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