The Clinical and Subjective Performance of Three Different MPDS With Silicon Hydrogel Lenses

NCT ID: NCT01665612

Last Updated: 2015-03-06

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

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-08-31

Brief Summary

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The purpose of the clinical investigation is to assess the clinical and subjective performance of three novel multipurpose disinfecting solutions (MPDS) in daily wear with two silicone hydrogel contact lenses (Lotrafilcon B and Comfilcon A).

Detailed Description

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Conditions

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Adverse Reaction to Contact Lens Solution

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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MPDS1

Contact lens care solution

Group Type EXPERIMENTAL

Contact lens care solution

Intervention Type DEVICE

Comparison of clinical and subjective performation of the contact lens care solutions used with two types of contact lenses

MPDS2

Contact lens care solution

Group Type ACTIVE_COMPARATOR

Contact lens care solution

Intervention Type DEVICE

Comparison of clinical and subjective performation of the contact lens care solutions used with two types of contact lenses

MPDS3

Contact lens care solution

Group Type ACTIVE_COMPARATOR

Contact lens care solution

Intervention Type DEVICE

Comparison of clinical and subjective performation of the contact lens care solutions used with two types of contact lenses

Interventions

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Contact lens care solution

Comparison of clinical and subjective performation of the contact lens care solutions used with two types of contact lenses

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* age above 18
* experienced contact lens user
* good health (self-reported)

Exclusion Criteria

* eye disease or eye operations
* pregnancy
* medication that can affect sight
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Finnsusp Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Riikka Järvinen, PhD

Role: STUDY_DIRECTOR

University of Turku, Finland; Finnsusp Ltd, Finland

Hanna Vaahtoranta-Lehtonen, Dr. Ophth.

Role: PRINCIPAL_INVESTIGATOR

Turku University Hospital

Locations

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Raision Näkökulma

Raisio, , Finland

Site Status

Countries

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Finland

Other Identifiers

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FI-2012

Identifier Type: -

Identifier Source: org_study_id

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