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Handling Comparison Between Two Contact Lens Types

Primary Purpose

Presbyopia

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
etafilcon A (multi-focal)
etafilcon A (sphere)
Sponsored by
Johnson & Johnson Vision Care, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Presbyopia

Eligibility Criteria

40 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  1. The subject must read, understand and sign the Statement of Informed Consent and receive a fully executed copy of the form.
  2. The subject must appear able and willing to adhere to the instructions set forth in this clinical protocol.
  3. The subject must be between 40 and 70 years of age.
  4. The subject's vertex corrected spherical equivalent distance refraction must be in the range of +0.25 to +4.00 or plano to -6.00 in each eye.
  5. The subject's refractive cylinder must be less than or equal to -0.75 D in each eye.
  6. The subject's ADD power must be in the range of +0.75 D to +2.50 D in each eye.
  7. The subject best corrected visual acuity of 20/20 -3 or better in each eye.
  8. Subject must own a wearable pair of spectacles.
  9. The subject must be an adaptable soft contact lens wearer in both eyes (i.e. worn lenses a minimum of 2 days per week for at least 8 hours per day, for 1 month or more of duration)
  10. The subject must already be wearing a presbyopic contact lens correction (e.g. reading spectacles over contact lenses, multifocal or monovision contact lenses, etc.) or if not responded positively to at least one symptom on the "Presbyopic Symptoms Questionnaire".

Exclusion Criteria:

  1. Currently pregnant or lactating (subjects who become pregnant during the study will be discontinued).
  2. Any ocular or systemic allergies or diseases that may interfere with contact lens wear.
  3. Any systemic disease, autoimmune disease, or use of medication, which may interfere with contact lens wear.
  4. Any ocular abnormality that may interfere with contact lens wear.
  5. Use of any ocular medication, with the exception of rewetting drops.
  6. Any previous intraocular surgery (e.g. radial keratotomy, photorefractive keratectomy (PRK), laser-assisted in situ keratomileusis (LASIK), etc.)
  7. Any grade 3 or greater slit lamp finding (e.g. edema, corneal neovascularization, corneal staining, tarsal abnormalities, conjunctival injection) which may contraindicate contact lens wear.
  8. Any ocular infection or inflammation.
  9. History of herpetic keratitis.
  10. Any corneal distortion or irregular cornea.
  11. History of binocular vision abnormality or strabismus.
  12. Any infectious disease (e.g. hepatitis, tuberculosis) or contagious immunosuppressive disease (e.g. HIV).
  13. Current history of diabetes.
  14. Participation in any contact lens or lens care product clinical trial within 30 days prior to study enrollment.

Sites / Locations

  • Baymeadows Vision Center
  • Eye Elements Eyecare
  • Vistakon Research Clinic
  • Golden Family Eyecare
  • Eye Associates of Winter Park
  • Central Ohio Eyecare
  • Optometry Group LLC
  • Nashville Vision Associates

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

etafilcon A(sphere)/etafilcon A(multi-focal)

etafilcon A(multi-focal)/etafilcon A(sphere)

Arm Description

Subjects were randomized to one of two lens wear sequences. subjects randomized to this sequence received etafilcon A (sphere) contact lens first and then the etafilcon A (multi-focal) contact lens second.

Subjects were randomized to one of two lens wear sequences. subjects randomized to this sequence received etafilcon A (multi-focal) contact lens first and then the etafilcon A (sphere) contact lens second.

Outcomes

Primary Outcome Measures

Overall Lens Handling Using the Contact Lens User Experience(CLUE) TM Questionnaire.
CLUE Overall Lens Handling is assessed using the Contact Lens User Experience (CLUE)TM questionnaire. CLUE is a validated patient-reported outcomes questionnaire to assess patient experience attributes of soft, disposable contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population in the US, ages 18-65. Scores follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response. 97% of the scores fall within 0 and 120 (mean +/-3XSD).

Secondary Outcome Measures

Full Information

First Posted
December 3, 2014
Last Updated
June 18, 2018
Sponsor
Johnson & Johnson Vision Care, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT02310126
Brief Title
Handling Comparison Between Two Contact Lens Types
Study Type
Interventional

2. Study Status

Record Verification Date
June 2017
Overall Recruitment Status
Completed
Study Start Date
November 1, 2014 (Actual)
Primary Completion Date
December 1, 2014 (Actual)
Study Completion Date
December 1, 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Johnson & Johnson Vision Care, Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Subjects will evaluate each study lens in a random order. The lenses will be worn in both eyes for a short period.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Presbyopia

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Randomized
Enrollment
195 (Actual)

8. Arms, Groups, and Interventions

Arm Title
etafilcon A(sphere)/etafilcon A(multi-focal)
Arm Type
Active Comparator
Arm Description
Subjects were randomized to one of two lens wear sequences. subjects randomized to this sequence received etafilcon A (sphere) contact lens first and then the etafilcon A (multi-focal) contact lens second.
Arm Title
etafilcon A(multi-focal)/etafilcon A(sphere)
Arm Type
Active Comparator
Arm Description
Subjects were randomized to one of two lens wear sequences. subjects randomized to this sequence received etafilcon A (multi-focal) contact lens first and then the etafilcon A (sphere) contact lens second.
Intervention Type
Device
Intervention Name(s)
etafilcon A (multi-focal)
Other Intervention Name(s)
Investigational Multifocal Contact
Intervention Description
Each subject will wear the soft contact lenses for 15 minutes then remove the lenses.
Intervention Type
Device
Intervention Name(s)
etafilcon A (sphere)
Other Intervention Name(s)
1-DAY ACUVUE® MOIST®
Intervention Description
Each subject will wear the soft contact lenses for 15 minutes then remove the lenses.
Primary Outcome Measure Information:
Title
Overall Lens Handling Using the Contact Lens User Experience(CLUE) TM Questionnaire.
Description
CLUE Overall Lens Handling is assessed using the Contact Lens User Experience (CLUE)TM questionnaire. CLUE is a validated patient-reported outcomes questionnaire to assess patient experience attributes of soft, disposable contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population in the US, ages 18-65. Scores follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response. 97% of the scores fall within 0 and 120 (mean +/-3XSD).
Time Frame
15 minutes post Contact Lens Insertion

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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 +0.25 to +4.00 or plano to -6.00 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 D in each eye. The subject best corrected visual acuity of 20/20 -3 or better in each eye. Subject must own a wearable pair of spectacles. The subject must be an adaptable soft contact lens wearer in both eyes (i.e. worn lenses a minimum of 2 days per week for at least 8 hours per day, for 1 month or more of duration) The subject must already be wearing a presbyopic contact lens correction (e.g. reading spectacles over contact lenses, multifocal or monovision contact lenses, etc.) or if not responded positively to at least one symptom on the "Presbyopic Symptoms Questionnaire". Exclusion Criteria: Currently pregnant or lactating (subjects who become pregnant during the study will be discontinued). Any ocular or systemic allergies or diseases that may interfere with contact lens wear. Any systemic disease, autoimmune disease, or use of medication, which may interfere with 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, photorefractive keratectomy (PRK), laser-assisted in situ keratomileusis (LASIK), etc.) Any grade 3 or greater slit lamp finding (e.g. edema, corneal neovascularization, corneal staining, tarsal abnormalities, conjunctival injection) which may contraindicate contact lens wear. Any ocular infection or inflammation. History of herpetic keratitis. Any corneal distortion or irregular cornea. History of binocular vision abnormality or strabismus. Any infectious disease (e.g. hepatitis, tuberculosis) or contagious immunosuppressive disease (e.g. HIV). Current history of diabetes. Participation in any contact lens or lens care product clinical trial within 30 days prior to study enrollment.
Facility Information:
Facility Name
Baymeadows Vision Center
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32256
Country
United States
Facility Name
Eye Elements Eyecare
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32256
Country
United States
Facility Name
Vistakon Research Clinic
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32256
Country
United States
Facility Name
Golden Family Eyecare
City
Sarasota
State/Province
Florida
ZIP/Postal Code
34232
Country
United States
Facility Name
Eye Associates of Winter Park
City
Winter Park
State/Province
Florida
ZIP/Postal Code
32792
Country
United States
Facility Name
Central Ohio Eyecare
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43202
Country
United States
Facility Name
Optometry Group LLC
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38111
Country
United States
Facility Name
Nashville Vision Associates
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37205
Country
United States

12. IPD Sharing Statement

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Handling Comparison Between Two Contact Lens Types

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