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

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Novartis

Status and phase

Completed
Phase 4

Conditions

Healthy

Treatments

Drug: Povidone K25 eye drops (povidone)

Study type

Interventional

Funder types

Industry

Identifiers

NCT00135824
COCF355ADE01

Details and patient eligibility

About

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.

Enrollment

30 patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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