NCT02801006

Brief Summary

The aim of this study is to evaluate the clinical performance of stenfilcon A toric lenses compared with etafilcon A toric lenses for astigmatism. If it is valuable, the clinical performance of stenfilcon A toric lens is also evaluated compared with habitual lenses.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
41

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2016

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

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

April 1, 2016

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2016

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

June 10, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 15, 2016

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2016

Completed
1.1 years until next milestone

Results Posted

Study results publicly available

December 12, 2017

Completed
Last Updated

January 9, 2018

Status Verified

December 1, 2017

Enrollment Period

2 months

First QC Date

June 10, 2016

Results QC Date

November 8, 2017

Last Update Submit

December 11, 2017

Conditions

Astigmatism

Outcome Measures

Primary Outcomes (6)

  • Comfort

    Wearing comfort (throughout the day) for stenfilcon A and etafilcon A toric lens pair is assessed. Scale 0-10, 0= extremely uncomfortable cannot wear at all, 10=very comfortable and feel no lens at all

    2 weeks

  • Dryness

    Dryness (throughout the day) for stenfilcon A and etafilcon A toric lens pair is assessed. Scale 0-10, 0=extremely dried and cannot wear lens, 10=feel no dryness at all

    2 weeks

  • Clarity of Vision

    Clarity of vision (throughout the day) for stenfilcon A and etafilcon A toric lens pair is assessed. Scale 0-10, 0=blur vision and cannot see at all, 10=very clear with no blur vision at all

    2 weeks

  • Stability of Vision

    Stability of vision (throughout the day) for stenfilcon A and etafilcon A toric lens pair is assessed. Scale 0-10, 0=unstable vision and cannot see at all, 10=always stable vision

    2 weeks

  • Lens Handling

    Lens handling for stenfilcon A and etafilcon A toric lens pair is assessed. Scale 0-10, 0=cannot handle at all, 10=no problem at all

    2 weeks

  • Overall Satisfaction

    Overall satisfaction for stenfilcon A and etafilcon A toric lens pair is assessed. scale 0-10, 0=extremely un-satisfy, 10=very satisfy

    2 weeks

Study Arms (2)

stenfilcon A

EXPERIMENTAL

Participants will be randomized to wear stenfilcon A lens pair for two weeks during the cross over study.

Device: stenfilcon A

etafilcon A

ACTIVE COMPARATOR

Participants will be randomized to wear etafilcon A lens pair for two weeks during the cross over study.

Device: etafilcon A

Interventions

stenfilcon ADEVICE

contact lens

stenfilcon A
etafilcon ADEVICE

contact lens

etafilcon A

Eligibility Criteria

Age18 Years - 42 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Is between 18 years of age and 42 years of age.
  • Soft contact lens wearers who are not required to have Presbyopic correction.
  • Soft contact lens wearers without trouble.
  • Soft contact lens wearers who have the correctable astigmatism by lenses used in this study in the both eyes.
  • Has a prescribed SCL (Soft Contact Lens) power within the range of powers of the SCL for astigmatism which is used in this study.
  • Can achieve a corrected visual acuity of 1.0 or better.
  • Can read and understand the study information document, and sign the participation consent form.
  • Can visit the clinic at designated examination visits.
  • Has received periodical examinations at an eye clinic within the past two years.

You may not qualify if:

  • A person will be excluded from the study if he/she:
  • Has a systemic disease that may affect the ocular health.
  • Is pregnant or lactating.
  • Has received a systemic or local medication that may affect this study.
  • Has an infectious eye disease.
  • Has eye and systemic active allergic diseases that interferes with SCL wear.
  • Has an eye disease which is clinically judged to be severe such as corneal vascularization, limbal hyperemia, and corneal epithelium disorder
  • Has a history of hard contact lens wear within 30 days.
  • Is currently participating in another clinical research study.
  • Has undergone refractive surgery.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Kodama Eye Clinic

Terada, Kyoto, 610-0121, Japan

Location

Dougenzaka Ioti Eye Clinic

Shibuya City, Tokyo-to, 150-0043, Japan

Location

MeSH Terms

Conditions

Astigmatism

Condition Hierarchy (Ancestors)

Refractive ErrorsEye Diseases

Results Point of Contact

Title
Jose Vega, O.D., MSc., FAAO
Organization
CooperVision
javega@coopervision.com
9256213761

Study Officials

  • Yuji Kodama, MD, PhD

    Director, 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

June 10, 2016

First Posted

June 15, 2016

Study Start

April 1, 2016

Primary Completion

June 1, 2016

Study Completion

October 31, 2016

Last Updated

January 9, 2018

Results First Posted

December 12, 2017

Record last verified: 2017-12

Data Sharing

IPD Sharing
Will not share

Locations

JP(2)