Study of Glaucoma Treatment With Food Additives

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. Identifier: NCT00196677
Recruitment Status : Terminated (The trial was terminated due to investigator's decision)
First Posted : September 20, 2005
Last Update Posted : March 11, 2009
Information provided by:
Future Products Management

Brief Summary:
The purpose of this study is to determine if certain food additives are effective in the treatment of glaucoma, improving and reversing the progress of the disease.

Condition or disease Intervention/treatment Phase
Glaucomatous Neuropathy Drug: Vitamins, minerals and medical herbs Phase 1 Phase 2

Detailed Description:
Glaucomatous neuropathy is a condition that worsens with time causing atrophy of the optic nerve and narrowing of the visual field which may culminate in blindness. The treatment tested in the trial employs certain food additives intended to reverse this pathology.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 25 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Treatment of Glaucomatous Neuropathy With Food Additives
Study Start Date : September 2005
Actual Primary Completion Date : July 2008
Actual Study Completion Date : October 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Glaucoma
U.S. FDA Resources

Primary Outcome Measures :
  1. Improvement in vision field (Protocol24) in a Humphrey's instrument. Scoring according to the Agis study

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Stable open angle glaucoma - with equilibrated eye internal pressure
  • Above the age of 50 years and have severe damage that does not progress to the vision field in the upper and lower half. Scoring of the vision field will be made according to the Agis study instructions.

Exclusion Criteria:

  • Eye diseases excluding past cataract operation
  • Allergy to one of the components in the preparation
  • Deterioration in the vision field in the last year
  • Kidney diseases, gastrointestinal (G.I.) tract, liver diseases, coagulation problems and thyroid diseases
  • Persons who take steroids
  • Diabetics or unbalanced hyperglycemia
  • Autoimmune diseases
  • Hypertension (not responding to treatment)
  • Psychiatric treatment with drugs, psychiatric pathologies
  • Pregnancy
  • Ability to take more than 3 pills per day regularly
  • Smoking

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 identifier (NCT number): NCT00196677

Sheba Medical Center
Tel Hashomer, Israel, 52621
Sponsors and Collaborators
Future Products Management
Study Director: Meir Gorban, MD Future Products Management
Principal Investigator: Hani Levkovitch-Verbin, MD Sheba Medical Center

Responsible Party: Dr. Meir Gorban, Future Products Management Identifier: NCT00196677     History of Changes
Other Study ID Numbers: g88
First Posted: September 20, 2005    Key Record Dates
Last Update Posted: March 11, 2009
Last Verified: March 2009