Not Signed In -
Fluorometholone Ophthalmic Drops or Ointment |
Eflone; Flarex; Fluor-Op; FML; FML Forte |
Clinical Trial: Local Tolerability and Safety of Povidone K25 Eye Drops (Artificial Tears Containing Povidone) Vs. Placebo in Healthy Volunteers
This study has been completed.
|
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 subjects | Drug: Povidone K25 eye drops (povidone) | Phase IV |
MedlinePlus consumer health information
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:
Study start: March 2004
Eligibility
Ages Eligible for Study: 18 Years and above, Genders Eligible for Study: Both
Accepts Healthy Volunteers
Criteria
Inclusion Criteria:
- healthy subjects
- older than 18 years
- ocular discomfort less than 20 mm on 100 mm 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
Location Information
Study chairs or principal investigators
PD. Dr. G. Auffarth, Principal Investigator, Universitäts-Augenklinik, Im Neuenheimer Feld 400,
More Information
Study ID Numbers: COCF355ADE01
Last Updated: August 25, 2005
Record first received: August 25, 2005
ClinicalTrials.gov Identifier: NCT00135824
Health Authority: Germany: Federal Institute for Drugs and Medicinal Devices
ClinicalTrials.gov processed this record on 2005-08-30
Last Updated: August 25, 2005
Record first received: August 25, 2005
ClinicalTrials.gov Identifier: NCT00135824
Health Authority: Germany: Federal Institute for Drugs and Medicinal Devices
ClinicalTrials.gov processed this record on 2005-08-30
email this page
print this page
bookmark this page
feedback on this page
