Study of Glaucoma Treatment With Food Additives

Glaucomatous Neuropathy Clinical Trial

Official title:

Treatment of Glaucomatous Neuropathy With Food Additives

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00196677
• Other study ID #: g88
• Status: Terminated
• Phase: Phase 1/Phase 2
• First received: September 12, 2005
• Last updated: March 10, 2009
• Start date: September 2005
• Est. completion date: October 2008

Study information

• Verified date: March 2009
• Source: Future Products Management
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Israeli Health Ministry Pharmaceutical Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 25
• Est. completion date: October 2008
• Est. primary completion date: July 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years to 75 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Glaucomatous Neuropathy

Intervention

Drug:
• Vitamins, minerals and medical herbs

Locations

Country	Name	City	State
Israel	Sheba Medical Center	Tel Hashomer

Sponsors (1)

Lead Sponsor	Collaborator
Future Products Management

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Improvement in vision field (Protocol24) in a Humphrey's instrument. Scoring according to the Agis study