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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00135824
Recruitment Status : Completed
First Posted : August 26, 2005
Last Update Posted : November 17, 2011
Information provided by (Responsible Party):

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.

Condition or disease Intervention/treatment Phase
Healthy Drug: Povidone K25 eye drops (povidone) Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Local Tolerability and Safety of Povidone K25 (Artificial Tears Containing Povidone) vs. Placebo in Healthy Volunteers
Study Start Date : March 2004
Actual Primary Completion Date : May 2004
Actual Study Completion Date : May 2004

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tears

Primary Outcome Measures :
  1. ocular discomfort by using a visual analogue scale (VAS)

Secondary Outcome Measures :
  1. slit lamp assessment (conjunctival edema, palpebral hyperemia, lid edema)
  2. adverse events

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00135824

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

Responsible Party: Novartis Identifier: NCT00135824     History of Changes
Other Study ID Numbers: COCF355ADE01
First Posted: August 26, 2005    Key Record Dates
Last Update Posted: November 17, 2011
Last Verified: November 2011

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

Additional relevant MeSH terms:
Ophthalmic Solutions
Lubricant Eye Drops
Pharmaceutical Solutions
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Nasal Decongestants
Vasoconstrictor Agents
Respiratory System Agents
Plasma Substitutes
Blood Substitutes