Study of Glaucoma Treatment With Food Additives | NCT00196677

Studies
Study of Glaucoma Treatment With Food Additives

NCT00196677

Sponsor

Future Products Management

Status

Terminated

Last Update Posted

Mar 11, 2009Estimated

Enrollment

25Estimated

Phase

Phase 1Phase 2

Conditions

Glaucomatous Neuropathy

Interventions

Vitamins, minerals and medical herbs

Countries

Israel

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2009

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

The trial was terminated due to investigator's decision

Expanded Access Info

Start Date

Sep 2005

Primary Completion Date

Jul 2008Actual

Completion Date

Oct 2008Actual

First Submitted Date

Sep 12, 2005

First Submission Date that Met QC Criteria

Sep 19, 2005

First Posted Date

Sep 20, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 10, 2009

Last Update Posted Date

Mar 11, 2009Estimated

Description Module

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.

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

25Estimated

Name	Type	Description	Arm Group Labels	Other Names
Vitamins, minerals and medical herbs	Drug

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Improvement in vision field (Protocol24) in a Humphrey's instrument. Scoring according to the Agis study

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

40 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Meir Gorban, MD	Future Products Management	Study Director
Hani Levkovitch-Verbin, MD	Sheba Medical Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Sheba Medical Center		Tel Litwinsky		52621	Israel

Intervention Browse Module

MeSH Terms

ID	Term
D014815	Vitamins
D008903	Minerals

Ancestor Terms

ID	Term
D018977	Micronutrients
D045505	Physiological Effects of Drugs
D020228	Pharmacologic Actions
D020164	Chemical Actions and Uses

Browse Leaves

Not provided

Browse Branches

Not provided