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

Local Tolerability and Safety of Povidone K25 (Artificial Tears Containing Povidone) vs. Placebo in Healthy Volunteers

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00135824

Enrollment

Registered

2005-08-26

Start date

2004-03-31

Completion date

2004-05-31

Last updated

2011-11-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Keywords

Artificial eye drops, tolerability, healthy volunteers, povidone, healthy subjects

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.

Interventions

DRUGPovidone K25 eye drops (povidone)

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame
ocular discomfort by using a visual analogue scale (VAS)	—

Secondary

Measure	Time frame
slit lamp assessment (conjunctival edema, palpebral hyperemia, lid edema)	—
adverse events	—

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026