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Evaluation of the Performance of Investigational Contact Lenses in a Presbyopic Population

Primary Purpose

Presbyopia

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
etafilcon A
lotrafilcon B
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

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

Inclusion Criteria:

  1. Subjects must read, understand, and sign the STATEMENT OF INFORMED CONSENT and receive a fully executed copy of the form.
  2. Subjects must appear able and willing to adhere to the instructions set forth in the clinical protocol.
  3. Subjects must be between 40 and 70 years of age.
  4. Subjects' spherical equivalent distance refraction must be in the range of -3.75 to +3.75 in each eye.
  5. Subjects' refractive cylinder must be less than or equal to 0.75D in each eye.
  6. Subjects' ADD power must be in the range of +0.75 to +2.50D in each eye.
  7. Subjects' must have the best corrected visual acuity of 20/20-3 or better in each eye.
  8. Subjects' should own a wearable pair of spectacles.
  9. Subjects' must be an adapted soft contact lens wearer in both eyes (i.e. worn lenses a minimum of 2 days per week for at least 8 hours per wear day, for 1 month or more duration).
  10. Subjects' must respond positively to at least on symptom on the "Presbyopis Symptoms Questionnaire" or already be wearing a presbyopic contact lens correction (e.g. reading spectacles over contact lenses, multifocal or monovision contact lenses, etc.).

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 previous intraocular surgery (e.g. radial keratotomy, PRK, LASIK, etc.)
  5. 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.
  6. Any ocular infection.
  7. Any corneal distortion resulting from previous hard or rigid gas permeable contact lens wear.
  8. History of binocular vision abnormality or strabismus.
  9. Any infectious disease (e.g. hepatitis, tuberculosis) or contagious immunosuppressive disease (e.g. HIV).
  10. History of diabetes.
  11. Participation in any contact lens or lens care product clinical trial within 7 days prior to study enrollment.

Sites / Locations

  • RPS

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

etafilcon A/lotrafilcon B

lotrafilcon B/etafilcon A

Arm Description

Subjects were randomized to one of two lens wear sequences. Subject randomized to this sequence first wore the etafilcon A lens and then wore the lotrafilcon B lens.

Subjects were randomized to one of two lens wear sequences. Subject randomized to this sequence first wore the lotrafilcon B lens and then wore the etafilcon A lens.

Outcomes

Primary Outcome Measures

Binocular Distance Visual Acuity (LogMAR)
Distance time controlled LogMAR Visual Acuity was carried out binocularly with high luminance and high contrast, at 4m under 250 cd/m^2. The test was presented under the condition High luminance (250 cd/m^2) High Contrast (90%)
Binocular Near Visual Acuity (logMAR)
Near time controlled LogMAR Visual Acuity was carried out binocularly using High lumiance and High Contrast, at 40cm under 250 cd/m^2. The test was presented under the condition High Luminance (250cd/m^2) High Contrast (90%).
Percentage of Eyes With Corneal Staining Grade 3 or Higher
Corneal staining was evaluated in 5 corneal regions (Central, Inferior, Nasal, Temporal and Superior) using Sodium Fluorescein strips. The Fluorescien strip was lightly placed on the subject's inferior palpebral conjunctiva. The corneal Staining was graded using the scale Grade 0: No Staining, Grade 1: Trace(Minimal superficial staining or stippling), Grade 2: Mild (Regional or diffuse punctate staining), Grade 3:Moderate(Significant dense coalesced staining, corneal abrasion or foreign body tracks.), Grade 4 Severe(Severe abrasions greater than 2 mm in diameter, ulcerations, epithelial loss, or full thickness abrasion.). The data was dichotomized into two group subjects with grade 3 or higher and those subjects with less than Grade 3 for the maximum grade of corneal staining across all 5 regions.
Percentage of Eyes With Limbal Conjunctival Redness Grade 3 or Higher
The Limbus refers to the 1 to 2mm wide zone of conjunctiva and underlying tissue adjacent to where the cornea joins the sclera. Limbal Conjuctival Redness was graded in 4 regions (Nasal, Temporal, Inferior and Superior) using the Efron Grading Scale in 1 unit increments. Grade 0: Normal, Grade 1: Trace, Grade 2: Mild, Grade 3: Moderate, Grade 4: Severe. The data was dichotomized into two group subjects with grade 3 or higher Limbal Conjuctival Redness, and those subjects with less than Grade 3 for the maximum grade of all 4 regions.
Percentage of Eyes With Bulbar Conjunctival Redness Grade 3 or Higher
Bulbar Conjunctival Injection was assessed in 4 regions (Nasal, Temporal, Inferior and Superior) using an Efron Grading scale by 1 unit increments. Grade 0: Normal, Grade 1: Trace, Grade 2: Mild, Grade 3: Moderate, Grade 4:Severe. The data was dichotomized into two group subjects with grade 3 or higher Conjunctival injection, and those subjects with less than Grade 3 for the maximum grade of all 4 regions.
CLUE Overall Quality of Vision Using the Contact Lens User Experience (CLUE)TM Questionnaire
CLUE Overall Quality of Vision 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 17, 2012
Last Updated
June 18, 2018
Sponsor
Johnson & Johnson Vision Care, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT01763047
Brief Title
Evaluation of the Performance of Investigational Contact Lenses in a Presbyopic Population
Study Type
Interventional

2. Study Status

Record Verification Date
May 2016
Overall Recruitment Status
Completed
Study Start Date
November 2012 (undefined)
Primary Completion Date
February 2013 (Actual)
Study Completion Date
February 2013 (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
The objective of this study is to evaluate the performance of a novel multifocal lens system.

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
None (Open Label)
Allocation
Randomized
Enrollment
298 (Actual)

8. Arms, Groups, and Interventions

Arm Title
etafilcon A/lotrafilcon B
Arm Type
Active Comparator
Arm Description
Subjects were randomized to one of two lens wear sequences. Subject randomized to this sequence first wore the etafilcon A lens and then wore the lotrafilcon B lens.
Arm Title
lotrafilcon B/etafilcon A
Arm Type
Active Comparator
Arm Description
Subjects were randomized to one of two lens wear sequences. Subject randomized to this sequence first wore the lotrafilcon B lens and then wore the etafilcon A lens.
Intervention Type
Device
Intervention Name(s)
etafilcon A
Intervention Description
To be worn in a daily wear modality for a minimum of 6 hours per day.
Intervention Type
Device
Intervention Name(s)
lotrafilcon B
Other Intervention Name(s)
AirOptix Aqua Multifocal
Intervention Description
Lenses will be worn in a reuseable modality; cleaned and disinfected each night.
Primary Outcome Measure Information:
Title
Binocular Distance Visual Acuity (LogMAR)
Description
Distance time controlled LogMAR Visual Acuity was carried out binocularly with high luminance and high contrast, at 4m under 250 cd/m^2. The test was presented under the condition High luminance (250 cd/m^2) High Contrast (90%)
Time Frame
8-12 days post wear
Title
Binocular Near Visual Acuity (logMAR)
Description
Near time controlled LogMAR Visual Acuity was carried out binocularly using High lumiance and High Contrast, at 40cm under 250 cd/m^2. The test was presented under the condition High Luminance (250cd/m^2) High Contrast (90%).
Time Frame
8-12 days post wear
Title
Percentage of Eyes With Corneal Staining Grade 3 or Higher
Description
Corneal staining was evaluated in 5 corneal regions (Central, Inferior, Nasal, Temporal and Superior) using Sodium Fluorescein strips. The Fluorescien strip was lightly placed on the subject's inferior palpebral conjunctiva. The corneal Staining was graded using the scale Grade 0: No Staining, Grade 1: Trace(Minimal superficial staining or stippling), Grade 2: Mild (Regional or diffuse punctate staining), Grade 3:Moderate(Significant dense coalesced staining, corneal abrasion or foreign body tracks.), Grade 4 Severe(Severe abrasions greater than 2 mm in diameter, ulcerations, epithelial loss, or full thickness abrasion.). The data was dichotomized into two group subjects with grade 3 or higher and those subjects with less than Grade 3 for the maximum grade of corneal staining across all 5 regions.
Time Frame
8-12 days post wear
Title
Percentage of Eyes With Limbal Conjunctival Redness Grade 3 or Higher
Description
The Limbus refers to the 1 to 2mm wide zone of conjunctiva and underlying tissue adjacent to where the cornea joins the sclera. Limbal Conjuctival Redness was graded in 4 regions (Nasal, Temporal, Inferior and Superior) using the Efron Grading Scale in 1 unit increments. Grade 0: Normal, Grade 1: Trace, Grade 2: Mild, Grade 3: Moderate, Grade 4: Severe. The data was dichotomized into two group subjects with grade 3 or higher Limbal Conjuctival Redness, and those subjects with less than Grade 3 for the maximum grade of all 4 regions.
Time Frame
8-12 days post wear
Title
Percentage of Eyes With Bulbar Conjunctival Redness Grade 3 or Higher
Description
Bulbar Conjunctival Injection was assessed in 4 regions (Nasal, Temporal, Inferior and Superior) using an Efron Grading scale by 1 unit increments. Grade 0: Normal, Grade 1: Trace, Grade 2: Mild, Grade 3: Moderate, Grade 4:Severe. The data was dichotomized into two group subjects with grade 3 or higher Conjunctival injection, and those subjects with less than Grade 3 for the maximum grade of all 4 regions.
Time Frame
8-12 days post wear
Title
CLUE Overall Quality of Vision Using the Contact Lens User Experience (CLUE)TM Questionnaire
Description
CLUE Overall Quality of Vision 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
8-12 days post wear

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: Subjects must read, understand, and sign the STATEMENT OF INFORMED CONSENT and receive a fully executed copy of the form. Subjects must appear able and willing to adhere to the instructions set forth in the clinical protocol. Subjects must be between 40 and 70 years of age. Subjects' spherical equivalent distance refraction must be in the range of -3.75 to +3.75 in each eye. Subjects' refractive cylinder must be less than or equal to 0.75D in each eye. Subjects' ADD power must be in the range of +0.75 to +2.50D in each eye. Subjects' must have the best corrected visual acuity of 20/20-3 or better in each eye. Subjects' should own a wearable pair of spectacles. Subjects' must be an adapted soft contact lens wearer in both eyes (i.e. worn lenses a minimum of 2 days per week for at least 8 hours per wear day, for 1 month or more duration). Subjects' must respond positively to at least on symptom on the "Presbyopis Symptoms Questionnaire" or already be wearing a presbyopic contact lens correction (e.g. reading spectacles over contact lenses, multifocal or monovision contact lenses, etc.). 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 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. Any ocular infection. Any corneal distortion resulting from previous hard or rigid gas permeable contact lens wear. History of binocular vision abnormality or strabismus. Any infectious disease (e.g. hepatitis, tuberculosis) or contagious immunosuppressive disease (e.g. HIV). History of diabetes. Participation in any contact lens or lens care product clinical trial within 7 days prior to study enrollment.
Facility Information:
City
Mission Viejo
State/Province
California
Country
United States
Facility Name
RPS
City
Jacksonville
State/Province
Florida
Country
United States
City
Jacksonville
State/Province
Florida
Country
United States
City
Saint Augustine
State/Province
Florida
Country
United States
City
Tallahassee
State/Province
Florida
Country
United States
City
Winter Park
State/Province
Florida
Country
United States
City
Roswell
State/Province
Georgia
Country
United States
City
Lutherville
State/Province
Maryland
Country
United States
City
Closter
State/Province
New Jersey
Country
United States
City
New York
State/Province
New York
Country
United States
City
Denver
State/Province
North Carolina
Country
United States
City
Athens
State/Province
Ohio
Country
United States
City
Kingston
State/Province
Pennsylvania
Country
United States
City
Warwick
State/Province
Rhode Island
Country
United States
City
Memphis
State/Province
Tennessee
Country
United States
City
Amarillo
State/Province
Texas
Country
United States
City
Tyler
State/Province
Texas
Country
United States
City
Salt Lake City
State/Province
Utah
Country
United States
City
Salem
State/Province
Virginia
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Evaluation of the Performance of Investigational Contact Lenses in a Presbyopic Population

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