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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.
Information provided by (Responsible Party):
Novartis Identifier:
First received: August 25, 2005
Last updated: November 16, 2011
Last verified: November 2011
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
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:

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)

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes

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
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Please refer to this study by its identifier: NCT00135824

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

Responsible Party: Novartis 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
healthy volunteers
healthy subjects

Additional relevant MeSH terms:
Lubricant Eye Drops
Ophthalmic Solutions
Pharmaceutical Solutions
Plasma Substitutes
Blood Substitutes
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Nasal Decongestants
Vasoconstrictor Agents
Respiratory System Agents processed this record on October 27, 2016