Antisecretory Factor (AF) Effects on Intraocular-pressure

NCT02731118 | Terminated Phase 3

• 1 other identifier: Sal/2016
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Glaucoma

Keywords

glaucoma; intraocular pressure lowering treatment; antisectory factor (AF); Salovum

Outcome Measures

Primary Outcomes (1)

• Intraocular pressure (IOP)

  IOP lowering effect of treatment or placebo over 14 days

  2 weeks

Study Arms (2)

Placebo and Salovum

EXPERIMENTAL

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; Dietary Supplement: Placebo

Salovum and placebo

EXPERIMENTAL

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; Dietary Supplement: Placebo

Interventions

Salovum DIETARY_SUPPLEMENT

AF-enriched egg yolk

Placebo and Salovum; Salovum and placebo

Placebo DIETARY_SUPPLEMENT

egg yolk

Placebo and Salovum; Salovum and placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• open angle glaucoma, ocular hypertension

You may not qualify if:

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

Sponsors & Collaborators

• St. Erik Eye Hospital: lead

Study Sites (1)

St Erik Eye Hospital

Stockholm, 112 82, Sweden

Location

MeSH Terms

Conditions

Glaucoma

Condition Hierarchy (Ancestors)

Ocular Hypertension; Eye Diseases

Study Officials

• Enping Chen, MD PhD

  St. Erik Eye Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD PhD

Study Record Dates

• First Submitted: April 2, 2016
• First Posted: April 7, 2016
• Study Start: April 1, 2016
• Primary Completion: December 31, 2020
• Study Completion: December 31, 2020
• Last Updated: May 14, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)