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

March 5, 2015 updated by: Finnsusp Ltd.

The Evaluation of the Clinical and Subjective Performance of Three Different Contact Lens Care Solutions With Silicon Hydrogel Lenses

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Finland
      • Raisio, Finland
        • Raision Näkökulma

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: MPDS1
Contact lens care solution
Device: Contact lens care solution
Comparison of clinical and subjective performation of the contact lens care solutions used with two types of contact lenses
ACTIVE_COMPARATOR: MPDS2
Contact lens care solution
Device: Contact lens care solution
Comparison of clinical and subjective performation of the contact lens care solutions used with two types of contact lenses
ACTIVE_COMPARATOR: MPDS3
Contact lens care solution
Device: Contact lens care solution
Comparison of clinical and subjective performation of the contact lens care solutions used with two types of contact lenses

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical performance
Time Frame: 1 month
TBUT, conjunctival and limbal hyperemia, corneal vascularization, epithelial and stromal oedema, corneal infiltrates, endothelial regularity, corneal staining and papillar conjunctivitis
1 month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Subjective performance
Time Frame: 1 month
E.g. Comfort
1 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Finnsusp Ltd.

Investigators

  • Study Director: Riikka Järvinen, PhD, University of Turku, Finland; Finnsusp Ltd, Finland
  • Principal Investigator: Hanna Vaahtoranta-Lehtonen, Dr. Ophth., Turku University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2012

Primary Completion (ACTUAL)

January 1, 2015

Study Registration Dates

First Submitted

August 8, 2012

First Submitted That Met QC Criteria

August 10, 2012

First Posted (ESTIMATE)

August 15, 2012

Study Record Updates

Last Update Posted (ESTIMATE)

March 6, 2015

Last Update Submitted That Met QC Criteria

March 5, 2015

Last Verified

March 1, 2015

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • FI-2012

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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