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

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