Study of Glaucoma Treatment With Food Additives

This study has been terminated.
(The trial was terminated due to investigator's decision)
Sponsor:
Information provided by:
Future Products Management
ClinicalTrials.gov Identifier:
NCT00196677
First received: September 12, 2005
Last updated: March 10, 2009
Last verified: March 2009
  Purpose

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 Intervention Phase
Glaucomatous Neuropathy
Drug: Vitamins, minerals and medical herbs
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Treatment of Glaucomatous Neuropathy With Food Additives

Resource links provided by NLM:


Further study details as provided by Future Products Management:

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

Estimated Enrollment: 25
Study Start Date: September 2005
Study Completion Date: October 2008
Primary Completion Date: July 2008 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   40 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00196677

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

No publications provided

Responsible Party: Dr. Meir Gorban, Future Products Management
ClinicalTrials.gov Identifier: NCT00196677     History of Changes
Other Study ID Numbers: g88
Study First Received: September 12, 2005
Last Updated: March 10, 2009
Health Authority: Israel: Israeli Health Ministry Pharmaceutical Administration

Additional relevant MeSH terms:
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 22, 2014