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Clinical Evaluation of a Multifocal Contact Lens on Symptomatic Patients

Primary Purpose

Presbyopia

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
etafilcon A multifocal contact lens
etafilcon A Contact Lens
Sponsored by
Johnson & Johnson Vision Care, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Presbyopia

Eligibility Criteria

35 Years - 47 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • To have signed an informed consent form (documented by the investigator in the Case Report Form [CRF]).
  • Be existing daily wear spherical single-vision soft CL wearers (no extended wear in the last 3 months, but silicone hydrogels in daily wear are allowed).
  • Between 35 and 47 years of age (inclusive).
  • Have a CL spherical distance requirement between -1.00D and -6.00D (-6.50D refractive) in both eyes.
  • Refractive astigmatism of 0.75D or less in both eyes.
  • Visual symptoms associated with near vision
  • Be correctable to a visual acuity of 6/9 (20/30) or better in each eye.

  • Have normal eyes with no evidence of abnormality or disease. For the purpose of this study a normal eye is defined as one having:

    1. No amblyopia.
    2. No evidence of lid abnormality or infection.
    3. No conjunctival abnormality or infection.
    4. No clinically significant slit lamp findings (i.e. stromal haze, staining, scarring, Vascularization, infiltrates or abnormal opacities).
    5. No other active ocular disease.

Exclusion Criteria:

  • Monovision user or multifocal CL wearer.
  • Regular user of reading spectacles (i.e. daily usage).
  • Requires concurrent ocular medication.
  • Clinically significant (Grade 3 or 4) corneal stromal haze, corneal Vascularization, tarsal abnormalities, bulbar hyperemia, limbal hyperemia, or any other abnormality of the cornea that would contraindicate CL wear.
  • Corneal staining Grade 3 in more than two regions.
  • Has had any anterior ocular surgery. Has had any other ocular surgery or injury within 8 weeks immediately prior to enrollment for this study.
  • Pre-existing ocular irritation that would preclude CL fitting.
  • Keratoconus or other corneal irregularity.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

etafilcon A multifocal / etafilcon A sphere

etafilcon A sphere / etafilcon A multifocal

Arm Description

period 1: etafilcon A multifocal worn, period 2: etafilcon A sphere worn.

period 1: etafilcon A sphere worn, period 2: etafilcon A multifocal worn.

Outcomes

Primary Outcome Measures

Subject Reported Overall Vision Quality Using (CLUE)TM Questionnaire
The Contact Lens User Experience (CLUE) Questionnaire is a validated patient-reported outcomes questionnaire to assess patient-experience attributes of soft, disposable contact lenses 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, with scores ranging from 0-120.
Monocular Amplitude of Accommodation
The amplitude of accommodation is a measure of the eyes ability to accommodate or focus on near objects. The method used was the push-up/push-down method performed monocularly. One eye was occluded and using the smallest print the subject was able to read, the reading chart was slowly moved towards the subject. The subject was asked them to indicate when the print first becomes blurred. The distance was noted and the amplitude of accommodation was calculated.

Secondary Outcome Measures

Proportion of Subjects With Near Vision Symptoms as Assessed by the NVQ
Proportion of subjects reporting frequent/constant near vision problem per the Near Vision Questionnaire (NVQ). The NVQ was used to assess subjects' near vision problems. Subjects graded each question using a 5-level Likert-type scale (5-levels: never, infrequent, sometimes, frequently, constantly).
Subject Reported Lens Comfort Using CLUE Questionnaire
Subject reported lens comfort was assessed using the CLUE Questionnaire. CLUE is a validated patient-reported outcomes questionnaire to assess patient-experience attributes of soft, disposable contact lenses 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. Scores range from 0 -120.
Comfortable Wearing Time
Comfortable wearing time was measured using self-reported subject awareness of irritation at a given time of day, rounded to the nearest half-hour. Could be described as aware of issue or completely comfortable.
Proportion of Subjects Benefiting From the Binocular +/-1.00D Accommodative Flipper
Utility of the use of the Binocular +/-1.00D accommodative flipper as a screening tool for those emerging presbyopia subjects

Full Information

First Posted
November 18, 2009
Last Updated
June 18, 2018
Sponsor
Johnson & Johnson Vision Care, Inc.
Collaborators
Visioncare Research Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT01016652
Brief Title
Clinical Evaluation of a Multifocal Contact Lens on Symptomatic Patients
Study Type
Interventional

2. Study Status

Record Verification Date
August 2017
Overall Recruitment Status
Completed
Study Start Date
October 1, 2009 (Actual)
Primary Completion Date
December 1, 2009 (Actual)
Study Completion Date
December 1, 2009 (Actual)

3. Sponsor/Collaborators

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

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to evaluate the effect of a multi-focal contact lens on symptomatic patients.

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
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
49 (Actual)

8. Arms, Groups, and Interventions

Arm Title
etafilcon A multifocal / etafilcon A sphere
Arm Type
Other
Arm Description
period 1: etafilcon A multifocal worn, period 2: etafilcon A sphere worn.
Arm Title
etafilcon A sphere / etafilcon A multifocal
Arm Type
Other
Arm Description
period 1: etafilcon A sphere worn, period 2: etafilcon A multifocal worn.
Intervention Type
Device
Intervention Name(s)
etafilcon A multifocal contact lens
Intervention Description
low-add multifocal contact lens
Intervention Type
Device
Intervention Name(s)
etafilcon A Contact Lens
Intervention Description
standard sphere contact lens
Primary Outcome Measure Information:
Title
Subject Reported Overall Vision Quality Using (CLUE)TM Questionnaire
Description
The Contact Lens User Experience (CLUE) Questionnaire is a validated patient-reported outcomes questionnaire to assess patient-experience attributes of soft, disposable contact lenses 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, with scores ranging from 0-120.
Time Frame
week 4
Title
Monocular Amplitude of Accommodation
Description
The amplitude of accommodation is a measure of the eyes ability to accommodate or focus on near objects. The method used was the push-up/push-down method performed monocularly. One eye was occluded and using the smallest print the subject was able to read, the reading chart was slowly moved towards the subject. The subject was asked them to indicate when the print first becomes blurred. The distance was noted and the amplitude of accommodation was calculated.
Time Frame
week 4
Secondary Outcome Measure Information:
Title
Proportion of Subjects With Near Vision Symptoms as Assessed by the NVQ
Description
Proportion of subjects reporting frequent/constant near vision problem per the Near Vision Questionnaire (NVQ). The NVQ was used to assess subjects' near vision problems. Subjects graded each question using a 5-level Likert-type scale (5-levels: never, infrequent, sometimes, frequently, constantly).
Time Frame
week 4
Title
Subject Reported Lens Comfort Using CLUE Questionnaire
Description
Subject reported lens comfort was assessed using the CLUE Questionnaire. CLUE is a validated patient-reported outcomes questionnaire to assess patient-experience attributes of soft, disposable contact lenses 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. Scores range from 0 -120.
Time Frame
week 4
Title
Comfortable Wearing Time
Description
Comfortable wearing time was measured using self-reported subject awareness of irritation at a given time of day, rounded to the nearest half-hour. Could be described as aware of issue or completely comfortable.
Time Frame
week 4
Title
Proportion of Subjects Benefiting From the Binocular +/-1.00D Accommodative Flipper
Description
Utility of the use of the Binocular +/-1.00D accommodative flipper as a screening tool for those emerging presbyopia subjects
Time Frame
Baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
47 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: To have signed an informed consent form (documented by the investigator in the Case Report Form [CRF]). Be existing daily wear spherical single-vision soft CL wearers (no extended wear in the last 3 months, but silicone hydrogels in daily wear are allowed). Between 35 and 47 years of age (inclusive). Have a CL spherical distance requirement between -1.00D and -6.00D (-6.50D refractive) in both eyes. Refractive astigmatism of 0.75D or less in both eyes. Visual symptoms associated with near vision Be correctable to a visual acuity of 6/9 (20/30) or better in each eye. Have normal eyes with no evidence of abnormality or disease. For the purpose of this study a normal eye is defined as one having: No amblyopia. No evidence of lid abnormality or infection. No conjunctival abnormality or infection. No clinically significant slit lamp findings (i.e. stromal haze, staining, scarring, Vascularization, infiltrates or abnormal opacities). No other active ocular disease. Exclusion Criteria: Monovision user or multifocal CL wearer. Regular user of reading spectacles (i.e. daily usage). Requires concurrent ocular medication. Clinically significant (Grade 3 or 4) corneal stromal haze, corneal Vascularization, tarsal abnormalities, bulbar hyperemia, limbal hyperemia, or any other abnormality of the cornea that would contraindicate CL wear. Corneal staining Grade 3 in more than two regions. Has had any anterior ocular surgery. Has had any other ocular surgery or injury within 8 weeks immediately prior to enrollment for this study. Pre-existing ocular irritation that would preclude CL fitting. Keratoconus or other corneal irregularity.
Facility Information:
City
North Little Rock
State/Province
Arkansas
Country
United States
City
Blue Springs
State/Province
Missouri
Country
United States
City
Lake Ozark
State/Province
Missouri
Country
United States
City
Warren
State/Province
Ohio
Country
United States
City
Kittanning
State/Province
Pennsylvania
Country
United States
City
Warwick
State/Province
Rhode Island
Country
United States
City
Chamberlain
State/Province
South Dakota
Country
United States
City
Burlington
State/Province
Vermont
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Clinical Evaluation of a Multifocal Contact Lens on Symptomatic Patients

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