NCT01254006

Brief Summary

In this study the investigators are going to study the retinal nerve fibers layers (RNFL) modification of two groups of patients, one taking no drugs, the other taking forskolin, rutin and vitamins B1 and B2.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 29, 2010

Completed
7 days until next milestone

First Posted

Study publicly available on registry

December 6, 2010

Completed
Last Updated

December 6, 2010

Status Verified

August 1, 2009

First QC Date

November 29, 2010

Last Update Submit

December 3, 2010

Conditions

Glaucoma

Outcome Measures

Primary Outcomes (1)

  • retinal nerve fibres layer thickness

Secondary Outcomes (1)

  • global risk threshold for glaucoma progression

Interventions

forskolin, rutin and vitamins B1 and B2DRUG

Eligibility Criteria

Age30 Years - 80 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age (30-80 years);
  • Baseline Intraocular pressure (IOP) (20-32 mmHg): average untreated Intra Ocular Pressure (IOP) for both eyes as determined from 2 to 4 visits within a 6-months period;
  • Central Corneal Thickness (CCT) (475-650 µm): average of 3 different measurements from both eyes during the same visit;
  • Pattern standard deviation (PSD) (0,50-3,00 dB) average of both eyes as stated on the most recent visual field index report
  • Vertical Cup/Disk ratio (0,00-0,80): average of both eyes
  • All these data were entered into a calculator specially designed for STAR (Scoring Tool for assessing risk) II parameter. The patients were divided into low-, moderate- and high risk groups according to the result given by the calculator.

You may not qualify if:

  • other ocular pathologies than glaucoma

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Univerisity La Sapienza

Latina, Italy

Location

MeSH Terms

Conditions

Glaucoma

Interventions

ColforsinRutin

Condition Hierarchy (Ancestors)

Ocular HypertensionEye Diseases

Intervention Hierarchy (Ancestors)

DiterpenesTerpenesHydrocarbonsOrganic ChemicalsFlavonolsFlavonoidsChromonesBenzopyransPyransHeterocyclic Compounds, 1-RingHeterocyclic CompoundsHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Design

Study Type
interventional
Phase
not applicable
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 29, 2010

First Posted

December 6, 2010

Last Updated

December 6, 2010

Record last verified: 2009-08

Locations

IT(1)