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Use of Topical Euphrasia, a Homeopathic Remedy in Ophthalmology

Primary Purpose

Iritis

Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Euphrasia
Prednisolone acetate
Sponsored by
Larkin Community Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Iritis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Patients undergoing Peripheral Laser Iridotomy

Exclusion Criteria:

  • Patients who have had an allergic reaction to Euphrasia (this will be asked to the patient at time of )
  • Patients who have had an adverse reaction to steroids (obtained by chart review to determine safety of drop use)
  • Patients who have inflammation before the LPI (Noted by seeing cell in the anterior chamber)
  • Patients who had any complications during their cataract surgery (obtained by chart review to determine safety of procedure)
  • Patients in whom more than 1500mW of energy was used during the Peripheral Laser Iridotomy
  • Patients in whom the laser was used more than 130 times during the Peripheral Laser Iridotomy

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Experimental

    Arm Label

    Iritis prevention after LPI: prednisolone

    Iritis prevention after LPI: euphrasia

    Arm Description

    To use prednisolone acetate after and peripheral laser iridotomy to determine efficacy and side effects compared to arm 2.

    To use euphrasia after and peripheral laser iridotomy to determine efficacy and side effects compared to arm 1.

    Outcomes

    Primary Outcome Measures

    Anti-inflammatory
    Quantitative amount of cell in the anterior chamber (0-5) Measurement of cell in the anterior chamber: 0 = 0 cells; 1 = 1 to 10 cells; 2 = 11 to 20 cells; 3 = 21 to 50 cells; and 4 = >50 cells (based on studies used to assess efficacy of other topical steroids)

    Secondary Outcome Measures

    Side effects
    Number of Participants with Adverse Events as a Measure of Safety and Tolerability
    Pain prevention
    Pain assessment: Yes or No pain Pain will be measured as quantitative (Yes/No) (based on studies used to assess efficacy of other topical steroids)

    Full Information

    First Posted
    March 26, 2015
    Last Updated
    October 12, 2023
    Sponsor
    Larkin Community Hospital
    Collaborators
    Nova Southeastern University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02416128
    Brief Title
    Use of Topical Euphrasia, a Homeopathic Remedy in Ophthalmology
    Official Title
    Use of Topical Euphrasia, a Homeopathic Remedy in Ophthalmology
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2023
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    No participants enrolled
    Study Start Date
    April 30, 2015 (Anticipated)
    Primary Completion Date
    March 25, 2016 (Actual)
    Study Completion Date
    March 25, 2016 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Larkin Community Hospital
    Collaborators
    Nova Southeastern University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The investigators plan to use an herbal eye drop, Euphrasia, aka Eyebright, for post-operative inflammation for Peripheral Laser Iridotomy for the treatment of narrow angle glaucoma. A peripheral Laser Iridotomy is a simple laser procedure with few complications if the patient follows the post-operative instructions. In this procedure, a blue-green Argon laser is used to create an orifice in the iris to open the angle by allowing the aqueous from behind the iris to enter the anterior chamber. Rarely the procedure needs to be repeated. The main complications from this surgery are postoperative inflammation, bleeding, and postoperative pressure spikes. The investigators will be using Weleda's Euphrasia D3 eye drops. The investigators plan to do a double blinded randomized control trial to objectively measure ocular inflammation in the same process that was used for the steroid eye drops that are currently out on the market. Some patients will be receiving steroids, prednisolone acetate, others, the herbal eye drop.
    Detailed Description
    Status post Peripheral Laser Iridotomy Beraja Medical Institute has guidelines for the use of steroids after a Peripheral Laser Iridotomy. Patients are normally given prednisolone acetate ophthalmic solution, USP 1.0% to be used four times a day for seven days after the surgery. This protocol will also be used for the Euphrasia drops. This will help us compare the efficacy of the drugs as well as maintain a double blinded study. Patients will be given blank bottles with only an ID number containing either prednisolone acetate or the Euphrasia eye drop. Bottles will be numbered sequentially by the Larkin Community Hospital pharmacy resident once the drops have been transferred by her and records of which bottles contain which drops will then be stored on the local intranet. Patients will be given the exact same instructions as well as the instruction to come in/call the on-call resident immediately if there are any adverse side effects, and explained that the most common of which are expected to be signs of inflammation or allergy to the medication. The symptoms that the patients will be advised to call in for will be: redness, swelling, burning or itching lasting more than a few minutes, decrease/loss of vision lasting more than a few minutes. The phone number for the on-call resident is in the consent form. The patient will be given another copy of the consent form, if they do not have it, with the phone number of the on-call resident highlighted. Patients will be followed up by a resident ophthalmologist on days eight and fifteen post-operatively to measure anterior chamber cell clearing and pain. The resident will only know which number bottle was used, not the drops in the bottleThe resident will also be measuring intraocular pressure, using a Goldman tonometer, and noting any other adverse effects or change in medication or dosing.Goldman tonometers are the most common way that an ophthalmologist checks a patient's intraocular pressure. It is done by using a topical anesthetic and dye instilled onto the cornea. The resident then places the Goldman tonometer onto the cornea, using a slit lamp, and measures the intraocular pressure. An attending ophthalmologist will recheck all findings and intervene, if necessary. These days and measures of efficacy are being used because these are the days and efficacy measures that were used to determine efficacy of multiple different steroid eye drops. The goal of this project is to determine if Euphrasia eye drops are, at the very least, non-inferior to steroids in controlling intraocular inflammation in the post-operative period after peripheral laser iridotomy used in the treatment of narrow angle glaucoma. Euphrasia has been used for centuries for treating conjunctivitis, but there is no standardized method for delivery and very few other studies to prove its efficacy. Currently, steroid eye drops are the first choice to reduce intraocular inflammation. They are used after surgery, uveitis, and certain forms of conjunctivitis. The biggest problem with steroids is that some patients are "steroid responders." These individuals respond to the steroids by having a very large increase in their intraocular pressure which can lead to optic nerve damage. Up to 4% of patients who use steroids can have spikes in their pressures of up to 31mmHg, where normal intraocular pressure is 21 or less. These side effects can occur in as little of 5 days of taking the steroid eye drops. Other, less common side effects are: cataracts, exacerbation of bacterial/viral infections, ptosis, mydriasis, scleral melting, and eyelid skin atrophy. With a recent shift in the American public to wanting to use herbal supplements and medications, it is very important to have clinical studies done to prove the efficacy of this herb. It is also important to be able to give the public a treatment that has been proven to work and is compounded safely and reproducibly. There are two previous studies that were done in Germany, that have shown both the safety and efficacy of Euphrasia when used topically to treat inflammatory conditions of the eye (Stoss, M et.al. "Prospective Cohort Trial of Euphrasia Single-dose Eye Drops in Conjunctivitis." The Journal of Alternative and Complementary Medicine, Vol. 6, Number 6, 2000. pp499-508.) (Toelg, Michael. "Euphrasia D3 Eye Drops in Children." http://www.anthromed.org/Article.aspx?artpk=676 Accessed 2 July 2013.). To achieve our goals, a comparison of the Euphrasia eye drop products that are currently on the market must be done. Weleda's Euphrasia D3 eye drops will be tested against prednisolone acetate eye drops to compare efficacy in reducing intraocular inflammation in the post-operative period after a peripheral laser iridotomy. This will be measured using a similar protocol used to show efficacy of steroidal eye drops already on the market. The investigator swill be measuring inflammation, intraocular pressure, and assessing pain at given intervals during the patient's post-operative period. The investigators will also be looking for specific signs of side effects that are known to occur with steroids and any other unwanted side effects, see research strategy for specifics.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Iritis

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    ParticipantCare ProviderInvestigator
    Allocation
    Randomized
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Iritis prevention after LPI: prednisolone
    Arm Type
    Active Comparator
    Arm Description
    To use prednisolone acetate after and peripheral laser iridotomy to determine efficacy and side effects compared to arm 2.
    Arm Title
    Iritis prevention after LPI: euphrasia
    Arm Type
    Experimental
    Arm Description
    To use euphrasia after and peripheral laser iridotomy to determine efficacy and side effects compared to arm 1.
    Intervention Type
    Drug
    Intervention Name(s)
    Euphrasia
    Other Intervention Name(s)
    Eyebright
    Intervention Description
    1 drop in the treated eye QID X 10 days
    Intervention Type
    Drug
    Intervention Name(s)
    Prednisolone acetate
    Other Intervention Name(s)
    Pred Forte
    Intervention Description
    1 drop in the treated eye QID X 10 days
    Primary Outcome Measure Information:
    Title
    Anti-inflammatory
    Description
    Quantitative amount of cell in the anterior chamber (0-5) Measurement of cell in the anterior chamber: 0 = 0 cells; 1 = 1 to 10 cells; 2 = 11 to 20 cells; 3 = 21 to 50 cells; and 4 = >50 cells (based on studies used to assess efficacy of other topical steroids)
    Time Frame
    15 days post laser
    Secondary Outcome Measure Information:
    Title
    Side effects
    Description
    Number of Participants with Adverse Events as a Measure of Safety and Tolerability
    Time Frame
    15 days post laser
    Title
    Pain prevention
    Description
    Pain assessment: Yes or No pain Pain will be measured as quantitative (Yes/No) (based on studies used to assess efficacy of other topical steroids)
    Time Frame
    15 days post laser

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Patients undergoing Peripheral Laser Iridotomy Exclusion Criteria: Patients who have had an allergic reaction to Euphrasia (this will be asked to the patient at time of ) Patients who have had an adverse reaction to steroids (obtained by chart review to determine safety of drop use) Patients who have inflammation before the LPI (Noted by seeing cell in the anterior chamber) Patients who had any complications during their cataract surgery (obtained by chart review to determine safety of procedure) Patients in whom more than 1500mW of energy was used during the Peripheral Laser Iridotomy Patients in whom the laser was used more than 130 times during the Peripheral Laser Iridotomy
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Austin Bach, DO
    Organizational Affiliation
    Larkin Community Hospital/Nova Southeastern University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    IPD Sharing Plan Description
    Study was terminated
    Citations:
    PubMed Identifier
    14078870
    Citation
    ARMALY MF. EFFECT OF CORTICOSTEROIDS ON INTRAOCULAR PRESSURE AND FLUID DYNAMICS. I. THE EFFECT OF DEXAMETHASONE IN THE NORMAL EYE. Arch Ophthalmol. 1963 Oct;70:482-91. doi: 10.1001/archopht.1963.00960050484010. No abstract available.
    Results Reference
    result
    PubMed Identifier
    14078872
    Citation
    BECKER B, MILLS DW. CORTICOSTEROIDS AND INTRAOCULAR PRESSURE. Arch Ophthalmol. 1963 Oct;70:500-7. doi: 10.1001/archopht.1963.00960050502012. No abstract available.
    Results Reference
    result
    PubMed Identifier
    6514289
    Citation
    Foster CS, Forstot SL, Wilson LA. Mortality rate in rheumatoid arthritis patients developing necrotizing scleritis or peripheral ulcerative keratitis. Effects of systemic immunosuppression. Ophthalmology. 1984 Oct;91(10):1253-63. doi: 10.1016/s0161-6420(84)34160-4.
    Results Reference
    result
    PubMed Identifier
    11152054
    Citation
    Stoss M, Michels C, Peter E, Beutke R, Gorter RW. Prospective cohort trial of Euphrasia single-dose eye drops in conjunctivitis. J Altern Complement Med. 2000 Dec;6(6):499-508. doi: 10.1089/acm.2000.6.499.
    Results Reference
    result
    Links:
    URL
    http://www.ncbi.nlm.nih.gov/pmc/articles/PMC1359011/
    Description
    Congdon NG, Schein OD, von Kulajta P, Lubomski LH, Gilbert D , Katz J. "Corneal Complications Associated with Topical Ophthalmic Use of Nonsteroidal Antiinflammatory Drugs." Journal of Cataract Refractive Surgery. 2001 ;27(4):622- 631.
    URL
    http://www.cdc.gov/nchs/data/nhsr/nhsr011.pdf
    Description
    Cullne, K., Golosinkiy, A. "Ambulatory Surgery in the United States, 2006." National Health Statistics Report Number 11, Revised September 4, 2009.
    URL
    http://www.academia.edu/7210476/PDR_HERBAL_MEDICINES
    Description
    "Eyebright," PDR for Herbal Medicines Second Edition. Medical Economics Company, Inc. Montvale, NJ, 2000. Page 300.
    URL
    https://sblglobal.com/home
    Description
    SBL's Euphrasia 10% Eye Drops
    URL
    https://www.anthromed.org/library/2019/1/4/euphrasia-d3-eye-drops-in-children?rq=Euphrasia%20D3%20Eye%20Drops%20in%20Children
    Description
    Toelg, Michael. "Euphrasia D3 Eye Drops in Children."
    URL
    http://www.barnesandnoble.com/w/the-herbal-drugstore-linda-b-white/1013440593?ean=9780451205100
    Description
    White, L., Foster, S. The Herbal Drugstore. Penguin Group, 2002.

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    Use of Topical Euphrasia, a Homeopathic Remedy in Ophthalmology

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