NCT02537730

Brief Summary

Two week, Open Label, randomized, bilateral, crossover, 1 week of daily wear in each combination (lens / disinfecting cleaning system).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
33

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2015

Shorter than P25 for not_applicable

Geographic Reach
1 country

3 active sites

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 26, 2015

Completed
6 days until next milestone

Study Start

First participant enrolled

September 1, 2015

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 2, 2015

Completed
29 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2015

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2016

Completed
4 months until next milestone

Results Posted

Study results publicly available

September 20, 2016

Completed
Last Updated

August 18, 2020

Status Verified

August 1, 2020

Enrollment Period

1 month

First QC Date

August 26, 2015

Results QC Date

June 10, 2016

Last Update Submit

August 4, 2020

Conditions

Myopia

Outcome Measures

Primary Outcomes (1)

  • Ocular Health - Corneal Staining

    Corneal staining for Bioclean MPS (Multi-Purpose Solution) VII / comfilcon A combination and Aosept Clearcare / comfilcon A combination assessed by slit lamp. Grade 0-4, 0=normal, 1=trace, 2=mild, 3=moderate, 4=severe.

    1 week

Secondary Outcomes (3)

  • Comfort

    1 week

  • Dryness

    1 week

  • Stinging and Burning Sensation

    Baseline

Study Arms (2)

Bioclean MPS VII / comfilcon A combination

ACTIVE COMPARATOR

Participants were randomized to the Bioclean MPS VII / comfilcon A combination for one week during the cross over study.

Device: Bioclean MPS VIIDevice: comfilcon A

Aosept Clearcare / comfilcon A combination

ACTIVE COMPARATOR

Participants were randomized to the Aosept Clearcare / comfilcon A combination for one week during the cross over study.

Device: Aosept ClearcareDevice: comfilcon A

Interventions

Bioclean MPS VIIDEVICE

PHMB (Polyhexamethylene biguanide) base Disinfecting and Cleaning system

Bioclean MPS VII / comfilcon A combination
Aosept ClearcareDEVICE

Hydrogen Peroxide Disinfecting and Cleaning system

Aosept Clearcare / comfilcon A combination
comfilcon ADEVICE

contact lens

Also known as: Biofinity
Aosept Clearcare / comfilcon A combinationBioclean MPS VII / comfilcon A combination

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Is over 18 years of age (inclusive)
  • Has had a self-reported visual exam in the last two years
  • Has a CL (contact lens) spherical prescription between -0.25D (Diopters) and -12.00D (inclusive)
  • Has less than 1.00 D spectacle cylinder in each eye
  • Is correctable to a visual acuity of 20/20 or better in both eyes
  • Has clear corneas and no active ocular disease
  • Has read, understood and signed the informed consent letter
  • Is willing to comply with the wear schedule (at least 40hrs per week)
  • Is willing to comply with the visit schedule

You may not qualify if:

  • Has never worn contact lenses before
  • Currently wears rigid gas permeable contact lens
  • Has a history of not achieving comfortable CL (contact lens) wear (5 days per week; \> 8 hours per day)
  • Has a CL prescription outside the range of -0.25D to -12.00D
  • Has a spectacle cylinder greater than -0.75D of cylinder in either eye
  • Has best corrected spectacle distant vision worse than 20/20 in ether eye
  • Has any systemic disease affecting ocular health
  • Is using any systemic or topical medications that will affect ocular health
  • Has any ocular pathology or sever insufficiency of lacrimal secretion
  • Has persistent, clinically significant corneal or conjunctival staining
  • Has active neovascularization or any central corneal scars
  • Is aphakic
  • Is pregnant or lactating

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Kodama Eye Clinic

Joyo-shi, Kyoto, 610-0121, Japan

Location

Higashihara Eye Clinic

Kameoka, Kyoto, 621-0861, Japan

Location

Iwasaki Eye Clinic

Osaka, Osaka, 542-0082, Japan

Location

MeSH Terms

Conditions

Myopia

Condition Hierarchy (Ancestors)

Refractive ErrorsEye Diseases

Results Point of Contact

Title
Director Professional Services Organization
Organization
Coopervision Japan
taku.muraoka@jp.coopervision.com
81-3-5449-6619

Study Officials

  • Yuji Kodama, MD, PhD

    Kodama Eye Clinic

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 26, 2015

First Posted

September 2, 2015

Study Start

September 1, 2015

Primary Completion

October 1, 2015

Study Completion

June 1, 2016

Last Updated

August 18, 2020

Results First Posted

September 20, 2016

Record last verified: 2020-08

Locations

JP(3)