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

This study is currently recruiting participants.
Verified August 2012 by Finnsusp Ltd.
Sponsor:
Information provided by (Responsible Party):
Finnsusp Ltd.
ClinicalTrials.gov Identifier:
NCT01665612
First received: August 8, 2012
Last updated: August 10, 2012
Last verified: August 2012
History of Changes
  Purpose

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).


Condition Intervention
Adverse Reaction to Contact Lens Solution
 Device: Contact lens care solution

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Official Title: The Evaluation of the Clinical and Subjective Performance of Three Different Contact Lens Care Solutions With Silicon Hydrogel Lenses

Resource links provided by NLM:

MedlinePlus related topics: Eye Wear
U.S. FDA Resources

Further study details as provided by Finnsusp Ltd.:

Primary Outcome Measures:
  • Clinical performance [ Time Frame: 1 month ] [ Designated as safety issue: No ]
    TBUT, conjunctival and limbal hyperemia, corneal vascularization, epithelial and stromal oedema, corneal infiltrates, endothelial regularity, corneal staining and papillar conjunctivitis


Secondary Outcome Measures:
  • Subjective performance [ Time Frame: 1 month ] [ Designated as safety issue: No ]
    E.g. Comfort


Estimated Enrollment: 40
Study Start Date: August 2012
Estimated Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01665612

Contacts
Contact: Riikka Järvinen, PhD piilolinssitutkimus@gmail.com

Locations
Finland
Raision Näkökulma Recruiting
Raisio, Finland
Contact: Maria Lilja, BSc         piilolinssitutkimus@gmail.com    
Principal Investigator: Hanna Vaahtoranta-Lehtonen, Dr.            
Principal Investigator: Riikka Järvinen, PhD            
Principal Investigator: Jari Ahlgren, BSc.Optom.            
Sponsors and Collaborators
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, Finland
  More Information

No publications provided

Responsible Party: Finnsusp Ltd.
ClinicalTrials.gov Identifier: NCT01665612     History of Changes
Other Study ID Numbers: FI-2012
Study First Received: August 8, 2012
Last Updated: August 10, 2012
Health Authority: Finland: National supervisory authority for wellfare and health

Keywords provided by Finnsusp Ltd.:
Contact lens
Care solution
MPDS
comfort

ClinicalTrials.gov processed this record on June 17, 2013