Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Use of Topical Euphrasia, a Homeopathic Remedy in Ophthalmology

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02416128
Recruitment Status : Unknown
Verified April 2015 by Larkin Community Hospital.
Recruitment status was:  Enrolling by invitation
First Posted : April 14, 2015
Last Update Posted : April 14, 2015
Sponsor:
Collaborator:
Nova Southeastern University
Information provided by (Responsible Party):
Larkin Community Hospital

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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 Phase 2

  Show Detailed Description

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Prevention
Official Title: Use of Topical Euphrasia, a Homeopathic Remedy in Ophthalmology
Study Start Date : April 2015
Estimated Primary Completion Date : March 2016

Resource links provided by the National Library of Medicine


Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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 Name: 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 Name: Eyebright


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Anti-inflammatory [ Time Frame: 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 :
  1. Side effects [ Time Frame: 15 days post laser ]
    Number of Participants with Adverse Events as a Measure of Safety and Tolerability

  2. Pain prevention [ Time Frame: 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
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02416128


Sponsors and Collaborators
Larkin Community Hospital
Nova Southeastern University
Investigators
Layout table for investigator information
Principal Investigator: Austin Bach, DO Larkin Community Hospital/Nova Southeastern University
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Additional Information:
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.  This link exits the ClinicalTrials.gov site Cullne, K., Golosinkiy, A. "Ambulatory Surgery in the United States, 2006." National Health Statistics Report Number 11, Revised September 4, 2009.  This link exits the ClinicalTrials.gov site "Eyebright," PDR for Herbal Medicines Second Edition. Medical Economics Company, Inc. Montvale, NJ, 2000. Page 300.  This link exits the ClinicalTrials.gov site Shields MB. Textbook of Glaucoma. 4th ed. Philadelphia: Williams & Wilkins; 2000 .  This link exits the ClinicalTrials.gov site White, L., Foster, S. The Herbal Drugstore. Penguin Group, 2002.  This link exits the ClinicalTrials.gov site

Publications of Results:

Other Publications:

Layout table for additonal information
Responsible Party: Larkin Community Hospital
ClinicalTrials.gov Identifier: NCT02416128     History of Changes
Other Study ID Numbers: LCH-4-012015
First Posted: April 14, 2015    Key Record Dates
Last Update Posted: April 14, 2015
Last Verified: April 2015

Additional relevant MeSH terms:
Layout table for MeSH terms
Prednisolone
Methylprednisolone Acetate
Methylprednisolone
Methylprednisolone Hemisuccinate
Prednisolone acetate
Prednisolone hemisuccinate
Prednisolone phosphate
Anti-Inflammatory Agents
Glucocorticoids
Hormones
 Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Gastrointestinal Agents
Neuroprotective Agents
Protective Agents