NCT01665612

Brief Summary

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).

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2012

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

August 8, 2012

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 15, 2012

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2015

Completed
Last Updated

March 6, 2015

Status Verified

March 1, 2015

Enrollment Period

2.4 years

First QC Date

August 8, 2012

Last Update Submit

March 5, 2015

Conditions

Adverse Reaction to Contact Lens Solution

Keywords

Contact lensCare solutionMPDScomfort

Outcome Measures

Primary Outcomes (1)

  • Clinical performance

    TBUT, conjunctival and limbal hyperemia, corneal vascularization, epithelial and stromal oedema, corneal infiltrates, endothelial regularity, corneal staining and papillar conjunctivitis

    1 month

Secondary Outcomes (1)

  • Subjective performance

    1 month

Study Arms (3)

MPDS1

EXPERIMENTAL

Contact lens care solution

Device: Contact lens care solution

MPDS2

ACTIVE COMPARATOR

Contact lens care solution

Device: Contact lens care solution

MPDS3

ACTIVE COMPARATOR

Contact lens care solution

Device: Contact lens care solution

Interventions

Contact lens care solutionDEVICE

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

MPDS1MPDS2MPDS3

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • eye disease or eye operations
  • pregnancy
  • medication that can affect sight

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Raision Näkökulma

Raisio, Finland

Location

Study Officials

  • Riikka Järvinen, PhD

    University of Turku, Finland; Finnsusp Ltd, Finland

    STUDY DIRECTOR

  • Hanna Vaahtoranta-Lehtonen, Dr. Ophth.

    Turku University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 8, 2012

First Posted

August 15, 2012

Study Start

August 1, 2012

Primary Completion

January 1, 2015

Last Updated

March 6, 2015

Record last verified: 2015-03

Locations

FI(1)