Local Tolerability and Safety of Povidone K25 Eye Drops (Artificial Tears Containing Povidone) Versus Placebo in Healthy Volunteers

This study has been completed.

Sponsored by:	Novartis
Information provided by:	Novartis
ClinicalTrials.gov Identifier:	NCT00135824

Purpose

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.

Condition	Intervention	Phase
Healthy	Drug: Povidone K25 eye drops (povidone)	Phase IV

Drug Information available for: Tetrahydrozoline Tetrahydrozoline hydrochloride Povidone

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Local Tolerability and Safety of Povidone K25 (Artificial Tears Containing Povidone) Vs. Placebo in Healthy Volunteers

Further study details as provided by Novartis:

Primary Outcome Measures:

ocular discomfort by using a visual analogue scale (VAS)

Secondary Outcome Measures:

slit lamp assessment (conjunctival edema, palpebral hyperemia, lid edema)
adverse events

Estimated Enrollment:	30
Study Start Date:	March 2004

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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)

Additional exclusion criteria are defined in the protocol

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00135824

Sponsors and Collaborators

Novartis

Investigators

Principal Investigator:

PD. Dr. G. Auffarth

Universitäts-Augenklinik, Im Neuenheimer Feld 400,

More Information

Study ID Numbers:	COCF355ADE01
Study First Received:	August 25, 2005
Last Updated:	June 1, 2006
ClinicalTrials.gov Identifier:	NCT00135824
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Novartis:

Artificial eye drops
tolerability
healthy volunteers
povidone
healthy subjects

Study placed in the following topic categories:

Pseudoephedrine
Naphazoline
Lacerations
Oxymetazoline
Guaifenesin
Phenylephrine

Povidone
Ephedrine
Phenylpropanolamine
Tetrahydrozoline
Healthy

Additional relevant MeSH terms:

Respiratory System Agents
Sympathomimetics
Hematologic Agents
Physiological Effects of Drugs
Cardiovascular Agents
Pharmacologic Actions
Nasal Decongestants

Autonomic Agents
Therapeutic Uses
Blood Substitutes
Vasoconstrictor Agents
Peripheral Nervous System Agents
Plasma Substitutes

ClinicalTrials.gov processed this record on January 16, 2009