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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis
ClinicalTrials.gov Identifier:
NCT00135824
First received: August 25, 2005
Last updated: November 16, 2011
Last verified: November 2011
History of Changes
  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 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Local Tolerability and Safety of Povidone K25 (Artificial Tears Containing Povidone) vs. Placebo in Healthy Volunteers

Resource links provided by NLM:

U.S. FDA Resources

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

Enrollment: 30
Study Start Date: March 2004
Study Completion Date: May 2004
Primary Completion Date: May 2004 (Final data collection date for primary outcome measure)
  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

Locations
Germany
Novartis Investigational Site
Heidelberg, Germany, 69120
Sponsors and Collaborators
Novartis
Investigators
Principal Investigator: PD. Dr. G. Auffarth Universitäts-Augenklinik, Im Neuenheimer Feld 400,
  More Information

No publications provided

Responsible Party: Novartis
ClinicalTrials.gov Identifier: NCT00135824     History of Changes
Other Study ID Numbers: COCF355ADE01
Study First Received: August 25, 2005
Last Updated: November 16, 2011
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Novartis:
Artificial eye drops
tolerability
healthy volunteers
povidone
healthy subjects

Additional relevant MeSH terms:
Povidone
Tetrahydrozoline
Plasma Substitutes
Blood Substitutes
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Nasal Decongestants
 Vasoconstrictor Agents
Cardiovascular Agents
Respiratory System Agents
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 22, 2013