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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-03-31

Study Completion Date

2004-05-31

Brief Summary

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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.

Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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Povidone K25 eye drops (povidone)

Intervention Type DRUG

Eligibility Criteria

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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)

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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PD. Dr. G. Auffarth

Role: PRINCIPAL_INVESTIGATOR

Universitäts-Augenklinik, Im Neuenheimer Feld 400,

Locations

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Novartis Investigational Site

Heidelberg, , Germany

Site Status

Countries

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Germany

Other Identifiers

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COCF355ADE01

Identifier Type: -

Identifier Source: org_study_id