Dry Eye Syndromes
Conditions
Keywords
Dry Eye Syndromes, Lacrimal Apparatus Diseases
Brief 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.
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).
Interventions
DRUGEuphrasia-based homeopathic therapy
ophthalmic solution; 1 drop both eyes twice daily
DRUGCyclosporin solution
Cyclosporin solution; 1 drop both eyes twice daily
Sponsors
University of Missouri-Columbia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Ocular Surface Disease Index (OSDI) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Tear Film Breakup Time | 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. |
| Change in Fluorescein Staining Scale | Baseline, 6 weeks | Demonstrates abrasions on cornea and extent of disease. Graded on a scale of 0-5 with 5 being the worst score. |
| Change in Schirmer Tear Test With Anesthesia Result | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Change in Severity of Ocular Discomfort | Baseline, 6 weeks | This will be calculated using a composite score of the primary and secondary outcome measures. |
Countries
United States
Participant flow
Recruitment details
Study was conducted Dec 2007 to Sept 2008. Participants were evaluated in the Mason Eye Institute and underwent 4 measures of dry eyes at baseline and after 6 weeks of therapy.
Pre-assignment details
Participants will stop all common artificial tear use for 2 weeks prior to baseline examination and randomization.
Participants by arm
| Arm | Count |
|---|---|
| 2 Arm Study - Description Below Euphrasia based homeopathic therapy in combination with cyclosporin (Restasis)euphrasia based homeopathic therapy and cyclosporin : ophthalmic solution; 1 drop both eyes twice daily. Participants to undergo 4 measures of dry eyes at baseline and after 6 weeks of therapy: 1) tear film break-up; 2) corneal staining by fluorescein; 3) Shirmer's test; and 4) Ocular Surface Disease Index (OSDI). | 6 |
| Total | 6 |
Baseline characteristics
| Characteristic | 2 Arm Study - Description Below |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 3 Participants |
| Age, Categorical Between 18 and 65 years | 3 Participants |
| Age, Continuous | 67 years STANDARD_DEVIATION 6.6 |
| Gender Female | 4 Participants |
| Gender Male | 2 Participants |
| Region of Enrollment United States | 6 participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 6 |
| serious Total, serious adverse events | 0 / 6 |
Outcome results
Primary
Change in Ocular Surface Disease Index (OSDI)
Measures dry eye disease and effect on vision-related function. Measured on a scale of 0-100, with higher scores indicating greater disability.
Time frame: Start of treatment, 6 weeks
Population: Any data collected was not analyzed because the study was terminated after the PI left the institution. No data is available for reporting as all study personnel have left the institution.
Secondary
Change in Fluorescein Staining Scale
Demonstrates abrasions on cornea and extent of disease. Graded on a scale of 0-5 with 5 being the worst score.
Time frame: Baseline, 6 weeks
Population: Any data collected was not analyzed because the study was terminated after the PI left the institution. No data is available for reporting as all study personnel have left the institution.
Secondary
Change in Schirmer Tear Test With Anesthesia Result
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.
Time frame: Baseline, 6 weeks
Population: Any data collected was not analyzed because the study was terminated after the PI left the institution. No data is available for reporting as all study personnel have left the institution.
Secondary
Change in Tear Film Breakup Time
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.
Time frame: Baseline, 6 weeks
Population: Any data collected was not analyzed because the study was terminated after the PI left the institution. No data is available for reporting as all study personnel have left the institution.
Other Pre-specified
Change in Severity of Ocular Discomfort
This will be calculated using a composite score of the primary and secondary outcome measures.
Time frame: Baseline, 6 weeks
Population: Any data collected was not analyzed because the study was terminated after the PI left the institution. No data is available for reporting as all study personnel have left the institution.