Study of Glaucoma Treatment With Food Additives

NCT ID: NCT00196677

Last Updated: 2009-03-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-09-30

Study Completion Date

2008-10-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Glaucomatous Neuropathy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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Vitamins, minerals and medical herbs

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

40 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Future Products Management

OTHER

Sponsor Role lead

Responsible Party

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Future Products Management

Principal Investigators

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Meir Gorban, MD

Role: STUDY_DIRECTOR

Future Products Management

Hani Levkovitch-Verbin, MD

Role: PRINCIPAL_INVESTIGATOR

Sheba Medical Center

Locations

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Sheba Medical Center

Tel Litwinsky, , Israel

Site Status

Countries

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Israel

Other Identifiers

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g88

Identifier Type: -

Identifier Source: org_study_id

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