Use of Topical Euphrasia, a Homeopathic Remedy in Ophthalmology

Sponsor

Larkin Community Hospital (Other)

Overall Status

Withdrawn

CT.gov ID

NCT02416128

Collaborator

Nova Southeastern University (Other)

Enrollment

Arms

10.8

Anticipated Duration (Months)

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Iritis	Drug: Euphrasia Drug: Prednisolone acetate	N/A

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

0 participants

Allocation:

Randomized

Intervention Model:

Single Group Assignment

Masking:

Triple (Participant, Care Provider, Investigator)

Primary Purpose:

Treatment

Official Title:

Use of Topical Euphrasia, a Homeopathic Remedy in Ophthalmology

Anticipated Study Start Date :

Apr 30, 2015

Actual Primary Completion Date :

Mar 25, 2016

Actual Study Completion Date :

Mar 25, 2016

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Iritis prevention after LPI: prednisolone To use prednisolone acetate after and peripheral laser iridotomy to determine efficacy and side effects compared to arm 2.	Drug: Prednisolone acetate 1 drop in the treated eye QID X 10 days Other Names: Pred Forte
Experimental: Iritis prevention after LPI: euphrasia To use euphrasia after and peripheral laser iridotomy to determine efficacy and side effects compared to arm 1.	Drug: Euphrasia 1 drop in the treated eye QID X 10 days Other Names: Eyebright

Arm

Intervention/Treatment

Active Comparator: Iritis prevention after LPI: prednisolone

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

Drug: Prednisolone acetate

1 drop in the treated eye QID X 10 days

Other Names:

Pred Forte

Experimental: Iritis prevention after LPI: euphrasia

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

Drug: Euphrasia

1 drop in the treated eye QID X 10 days

Other Names:

Eyebright

Outcome Measures

Primary Outcome Measures

Anti-inflammatory [15 days post laser]
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 [15 days post laser]
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Pain prevention [15 days post laser]
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)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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