Dry Eye SyndromesPhase 2NCT01072526
Pilot Study of a Homeopathic Therapy in Combination With Cyclosporin (Restasis) in the Treatment of Dry Eye Disease
A Phase 2 study testing Euphrasia-based homeopathic therapy and Cyclosporin solution in people with Dry Eye Syndromes, run by University of Missouri-Columbia at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Dry Eye Syndromes
- What is being tested?
- Euphrasia-based homeopathic therapy and Cyclosporin solution
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 7 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2007to Aug 2010
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Missouri-Columbia, Mason Eye Institute
Columbia, Missouri, 65212
About this study
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.
Read the 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).
- Conditions
- Dry Eye Syndromes
- Being tested
- Euphrasia-based homeopathic therapy, Cyclosporin solution
- Keywords
- Dry Eye Syndromes, Lacrimal Apparatus Diseases
- Medical subject headings
- Dry Eye Syndromes, Lacrimal Apparatus Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Euphrasia-based homeopathic therapyDrug
Also called Artificial Tears
ophthalmic solution; 1 drop both eyes twice daily
Cyclosporin solutionDrug
Also called Restasis
Cyclosporin solution; 1 drop both eyes twice daily
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Active comparator | Subjects will receive Euphrasia-based homeopathic therapy (Artificial Tears) in combination with cyclosporin solution (Restasis) . Receives: Drug: Euphrasia-based homeopathic therapy; Drug: Cyclosporin solution |
| Control | Placebo comparator | Subjects will receive placebo in combination with cyclosporin solution (Restasis) . Receives: Drug: Cyclosporin solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Start of treatment, 6 weeks
Secondary outcomes (3)
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.
Measured: Baseline, 6 weeks
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.
Measured: Baseline, 6 weeks
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.
Measured: Baseline, 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2010 (estimated)
- Study startDec 2007
- Primary completionAug 2010
- Study completionAug 2010
Why it stopped: Study personnel left institution before study completion
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Dry Eye SyndromesStudies of the same condition, open and under way.
- More trials run by University of Missouri-ColumbiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Missouri-Columbia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lenworth N Johnson, MD, Principal investigator, University of Missouri-Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01072526
- Sponsor's protocol ID
- LNJ-1
- Other IDs
- IRB 1095817
- Status last verified
- Nov 2016
- First submitted
- 31 Dec 2007
- Last updated
- 12 Jan 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study of a Homeopathic Therapy in Combination With Cyclosporin (Restasis) in the Treatment of Dry Eye Disease
- ClinicalTrials.gov ID
- NCT01072526
- Acronym / sponsor ID
- LNJ-1
- Conditions
- Dry Eye Syndromes
- Keywords
- Dry Eye Syndromes, Lacrimal Apparatus Diseases
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study personnel left institution before study completion
- Enrolment
- 7 participants (actual)
- Lead sponsor
- University of Missouri-ColumbiaUniversity, hospital or other
- Study start
- Dec 2007
- Primary completion
- Aug 2010 (actual)
- Study completion
- Aug 2010 (actual)
- First posted
- 22 Feb 2010 (estimated)
- Results
- Posted 12 Jan 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Active comparator | Drug: Euphrasia-based homeopathic therapy, Drug: Cyclosporin solutionSubjects will receive Euphrasia-based homeopathic therapy (Artificial Tears) in combination with cyclosporin solution (Restasis) . |
| Control | Placebo comparator | Drug: Cyclosporin solutionSubjects will receive placebo in combination with cyclosporin solution (Restasis) . |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Euphrasia-based homeopathic therapyAlso: Artificial Tearsophthalmic solution; 1 drop both eyes twice daily | Drug | Intervention |
| Cyclosporin solutionAlso: RestasisCyclosporin solution; 1 drop both eyes twice daily | Drug | Control, Intervention |
Primary outcome
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.
3 secondary outcomes
Change in Tear Film Breakup Time
Time frame: Baseline, 6 weeks
Change in Fluorescein Staining Scale
Time frame: Baseline, 6 weeks
Change in Schirmer Tear Test With Anesthesia Result
Time frame: Baseline, 6 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lenworth N Johnson, MD principal investigator
University of Missouri-Columbia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Euphrasia-based homeopathic therapy and Cyclosporin solution in people with Dry Eye Syndromes, run by University of Missouri-Columbia at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 12 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 12 Jan 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Ocular Surface Disease Index (OSDI) (time frame: Start of treatment, 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jan 2017.