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Antisecretory Factor (AF) Effects on Intraocular-pressure

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.
 
ClinicalTrials.gov Identifier: NCT02731118
Recruitment Status : Unknown
Verified July 2017 by Enping Chen, St. Erik Eye Hospital.
Recruitment status was:  Recruiting
First Posted : April 7, 2016
Last Update Posted : July 13, 2017
Sponsor:
Information provided by (Responsible Party):
Enping Chen, St. Erik Eye Hospital

Brief Summary:

Glaucoma is a complex and chronic eye disease which damages the optic nerve. One of the main risk factors for the progression of glaucoma is IOP.

The aim of the study is to examine if Salovum, an anti-secretory factor (AF), can reduce the level of the intraocular pressure (IOP) in the eye of patients affected by glaucoma.

Anti-secretory factor (AF) is an endogenous protein which controls the transport of water and ions across the cell membrane. AF plays an important part in the immune system and has an anti-secretory and anti-inflammatory effect.

The investigators' hypothesis is that Salovum can restore a normal salt-water balance in the eye, which in turn would lower the IOP. This would eliminate or reduce the risk of subsequent visual impairments/neurological damage.


Condition or disease Intervention/treatment Phase
Glaucoma Dietary Supplement: Salovum Dietary Supplement: Placebo Phase 3

Show Show detailed description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Antisecretory Factor (AF) Effects on Intraocular-pressure: a Placebo-controlled Randomised Study
Study Start Date : April 2016
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : April 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Glaucoma

Arm Intervention/treatment
Experimental: Placebo and Salovum
6 times 4 gr placebo/Salovum day 1-2, 5 times 4 gr placebo/Salovum day 3-5, 4 times 4 gr placebo/Salovum day 6-14
Dietary Supplement: Salovum
AF-enriched egg yolk

Dietary Supplement: Placebo
egg yolk

Experimental: Salovum and placebo
6 times 4 gr Salovum/placebo day 1-2, 5 times 4 gr Salovum/placebo day 3-5, 4 times 4 gr Salovum/placebo day 6-14
Dietary Supplement: Salovum
AF-enriched egg yolk

Dietary Supplement: Placebo
egg yolk




Primary Outcome Measures :
  1. Intraocular pressure (IOP) [ Time Frame: 2 weeks ]
    IOP lowering effect of treatment or placebo over 14 days



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • open angle glaucoma, ocular hypertension

Exclusion Criteria:

  • other types of glaucoma, other types of ocular comorbidity, previous intra-ocular surgery

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 ClinicalTrials.gov identifier (NCT number): NCT02731118


Contacts
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Contact: Enping Chen, MD PhD 004686720000 enping.chen@sll.se
Contact: Laurence Quérat, M Sc 004686723240 laurence.querat@sll.se

Locations
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Sweden
St Erik Eye Hospital Recruiting
Stockholm, Sweden, 112 82
Contact: Enping Chen, MD PhD    004686720000    enping.chen@sll.se   
Sponsors and Collaborators
St. Erik Eye Hospital
Investigators
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Principal Investigator: Enping Chen, MD PhD St. Erik Eye Hospital

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Responsible Party: Enping Chen, MD PhD, St. Erik Eye Hospital
ClinicalTrials.gov Identifier: NCT02731118    
Other Study ID Numbers: Sal/2016
First Posted: April 7, 2016    Key Record Dates
Last Update Posted: July 13, 2017
Last Verified: July 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Enping Chen, St. Erik Eye Hospital:
glaucoma
intraocular pressure lowering treatment
antisectory factor (AF)
Salovum
Additional relevant MeSH terms:
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Glaucoma
Ocular Hypertension
Eye Diseases
Antisecretory factor
Antidiarrheals
Gastrointestinal Agents