NCT00135824

Brief Summary

Instillation of artificial tears is standard treatment in dry eye syndrome and in patients experiencing dry eye symptoms when wearing contact lenses. Povidone K25 eye drops (povidone) is an isotonic solution containing povidone to simulate normal tears viscosity. Safety and local tolerability of Povidone K25 is evaluated in healthy volunteers in comparison to placebo eye drops.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at P25-P50 for phase_4 healthy

Timeline
Completed

Started Mar 2004

Shorter than P25 for phase_4 healthy

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

Study Start

First participant enrolled

March 1, 2004

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2004

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2004

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

August 25, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 26, 2005

Completed
Last Updated

November 17, 2011

Status Verified

November 1, 2011

Enrollment Period

2 months

First QC Date

August 25, 2005

Last Update Submit

November 16, 2011

Conditions

Healthy

Keywords

Artificial eye dropstolerabilityhealthy volunteerspovidonehealthy subjects

Outcome Measures

Primary Outcomes (1)

  • ocular discomfort by using a visual analogue scale (VAS)

Secondary Outcomes (2)

  • slit lamp assessment (conjunctival edema, palpebral hyperemia, lid edema)

  • adverse events

Interventions

Povidone K25 eye drops (povidone)DRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Healthy subjects
  • Older than 18 years
  • Ocular discomfort less than 20 mm on 100 mm visual analogue scale (VAS) prior to treatment

You may not qualify if:

  • Known hypersensitivity to any of the constituents of the medications
  • Known allergic disposition (e.g. hay fever)
  • Wearing of contact lenses
  • Any kind of current eye disease (e.g. dry eye)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Novartis Investigational Site

Heidelberg, 69120, Germany

Location

MeSH Terms

Interventions

Povidone

Intervention Hierarchy (Ancestors)

PolyvinylsVinyl CompoundsAlkenesHydrocarbons, AcyclicHydrocarbonsOrganic ChemicalsPyrrolidinonesPyrrolidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPlasticsPolymersMacromolecular SubstancesBiomedical and Dental MaterialsManufactured MaterialsTechnology, Industry, and Agriculture

Study Officials

  • PD. Dr. G. Auffarth

    Universitäts-Augenklinik, Im Neuenheimer Feld 400,

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 25, 2005

First Posted

August 26, 2005

Study Start

March 1, 2004

Primary Completion

May 1, 2004

Study Completion

May 1, 2004

Last Updated

November 17, 2011

Record last verified: 2011-11

Locations

DE(1)