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

Novartis30 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Healthy

Interventions

Povidone K25 eye drops (povidone)DRUG

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Novartis Investigational Site

Heidelberg, Germany

Outcomes

Primary Outcomes

ocular discomfort by using a visual analogue scale (VAS)

Secondary Outcomes

slit lamp assessment (conjunctival edema, palpebral hyperemia, lid edema)

adverse events

Data from ClinicalTrials.gov

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