NCT02394925

Brief Summary

The primary objective of this study is to determine the retention rate over a two month period of vision correction in emmetropic, presbyopes fitted with multifocal contact lenses.

Trial Health

90
On Track

Trial Health Score

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

Enrollment
113

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2015

Shorter than P25 for not_applicable

Geographic Reach
2 countries

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

January 1, 2015

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 16, 2015

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 20, 2015

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2015

Completed
1.7 years until next milestone

Results Posted

Study results publicly available

May 15, 2017

Completed
Last Updated

June 19, 2018

Status Verified

April 1, 2017

Enrollment Period

8 months

First QC Date

March 16, 2015

Results QC Date

April 6, 2017

Last Update Submit

June 18, 2018

Conditions

Vision Correction

Outcome Measures

Primary Outcomes (1)

  • Proportion of Successful Contact Lens Wearers

    Proportion of Successful contact lens wearers is based on a subject's responses to two questionnaire items, "Overall Quality of Vision" and "Overall Comfort". Each item uses a 6 response like-rt scale (0= Not Applicable, 1=Excellent, 2=Very Good, 3=Good, 4=Fair and 5=Poor). The data from each item was dichotomized into two groups. If a subject responded "Excellent", "Very Good" or "Good" then the response=1, otherwise the response=0. The proportion of subjects with response=1 was reported as the proportion of successful contact lens wearers.

    2 months post wear

Study Arms (1)

Multifocal Test Contact Lens

EXPERIMENTAL

Subjects will wear the test lenses at least six hours per day, at least five days per week

Device: Multifocal Test Contact lens

Interventions

Multifocal Test Contact lensDEVICE

Used in a daily wear modality

Also known as: etafilcon A
Multifocal Test Contact Lens

Eligibility Criteria

Age40 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • The subject must read, understand and sign the Statement of Informed Consent and receive a fully executed copy of the form.
  • The subject must appear able and willing to adhere to the instructions set forth in this clinical protocol.
  • The subject must be between 40 and 70 years of age.
  • The subject's vertex corrected spherical equivalent distance refraction must be in the range of -1.00 to +2.00 in each eye.
  • The subject's refractive cylinder must be less than or equal to -0.75 D in each eye.
  • The subject's ADD power must be in the range of +0.75 D to +2.50.
  • The subject must have best corrected visual acuity of 20/25 or better in each eye.

You may not qualify if:

  • Currently pregnant or lactating (subjects who become pregnant during the study will be discontinued).
  • Any ocular or systemic allergies that contraindicate contact lens wear.
  • Any ocular or systemic disease, autoimmune disease, or use of medication, that contraindicates contact lens wear.
  • Any ocular abnormality that may interfere with contact lens wear.
  • Use of any ocular medication, with the exception of rewetting drops.
  • Any previous intraocular surgery (e.g. radial keratotomy, PRK, LASIK, etc.).
  • Any grade 3 or greater slit lamp findings (e.g. edema, corneal neovascularization, corneal staining, tarsal abnormalities, conjunctival injection) which may contraindicate contact lens wear.
  • History of herpetic keratitis.
  • Any ocular infection or inflammation.
  • Any corneal distortion or irregular cornea.
  • History of binocular vision abnormality or strabismus.
  • Any infectious disease (e.g. hepatitis, tuberculosis) or a contagious immunosuppressive disease (e.g. HIV).
  • History of diabetes.
  • Current or previous history of being prescribed a correction for distance vision.
  • Current or previous history of contact lens wear.
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Tallahassee Eye Center

Pensacola, Florida, 32503, United States

Location

Ocular Technology Group-International

London, SW1E 6AU, United Kingdom

Location

Results Point of Contact

Title
Thomas R. Karkkainen, OD, MS, FAAO Sr. Principal Research Optometrist
Organization
Johnson & Johnson Vision Care Inc.
TKarkkai@its.jnj.com
904 443-3402

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
GT60
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 16, 2015

First Posted

March 20, 2015

Study Start

January 1, 2015

Primary Completion

September 1, 2015

Study Completion

September 1, 2015

Last Updated

June 19, 2018

Results First Posted

May 15, 2017

Record last verified: 2017-04

Locations

US(1)GB(1)