Back to resultsEvaluation of an Investigational Multifocal Lens
Primary Purpose
Presbyopia
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
lotrafilcon B
etafilcon A
Sponsored by
About this trial
This is an interventional treatment trial for Presbyopia
Eligibility Criteria
Inclusion Criteria:
- The subjects were required to have read, understand, and signed 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.
- Between 40 and 70 years of age.
- Subjects must own a wearable pair of spectacles, if required for their distance vision.
- 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 of more duration)
- Already be wearing a presbyopic contact lens correction (e.g., reading spectacles over contact lenses, multifocal or monovision contact lenses, etc.) or if not respond positively to at least one symptom on the "Presbyopic Symptoms Questionnaire"*
- The subject's vertex corrected spherical equivalent distance refraction was required to be in the range +3.50 to -5.75 in each eye.
- Refractive cylinder ≤ -0.75 D in each eye.
- ADD power in the range +0.75 D to +2.50 D in each eye.
- Best corrected visual acuity of 20/20-3 or better in each eye.
Exclusion Criteria:
- Currently pregnant or lactating (subjects who became pregnant during the study were discontinued).
- Any ocular or systemic allergies that may have contraindicated contact lens wear.
- Any ocular or systemic disease, autoimmune disease, or use of medication, that may have contraindicated contact lens wear.
- Any ocular abnormality that may have interfered 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.).
- History of herpetic keratitis.
- 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.
- Participation in any contact lens or lens care product clinical trial within 30 days prior to study enrollment.
- 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 or inflammation.
- Any corneal distortion or irregular cornea.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
lotrafilcon B / etafilcon A
etafilcon A / lotrafilcon B
Arm Description
Subject randomized to this sequence will first be dispensed the lotrafilcon B contact lens and then the etafilcon A contact lens.
Subject randomized to this sequence will first be dispensed the etafilcon A contact lens and then the lotrafilcon B contact lens.
Outcomes
Primary Outcome Measures
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).
Distance Binocular Visual Acuity (LogMAR)
Distance time controlled LogMAR Visual Acuity was carried out binocularly with high luminance and high contrast.
Intermediate Binocular Visual Acuity (LogMAR)
Intermediate time controlled LogMAR Visual Acuity was carried out binocularly using High lumiance and High Contrast.
Near Binocular Visual Acuity (LogMAR)
Near time controlled LogMAR Visual Acuity was carried out binocularly using High lumiance and High Contrast.
Corneal Staining
Corneal staining is evaluated 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 staining, and those subjects with less than Grade 3. Below the percentage of subject eyes with grade 3 or higher is reported for each lens.
Bulbar Conjunctival Injection
The bulbar is the scelra. Bulbar Conjunctival Injection was assessed 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. Below the percentage of subject eyes with grade 3 or higher is reported for each lens.
Limbal Conjunctival Injection
The Limbus is the 1 to 2mm wide zone of conjunctiva and underlying tissue adjacent to where the cornea joins the sclera. Limbal Conjunctival Injection was assesed 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 Conjunctival injection, and those subjects with less than Grade 3. Below the percentage of subject eyes with grade 3 or higher is reported for each lens.
Contact Lens Fitting
Contact Lens fitting is reported as a binary response. Yes- acceptable lens fit, No- unacceptable lens fit. The percentage of subject eyes with acceptable fit is reported.
Secondary Outcome Measures
Full Information
NCT ID
NCT02223754
First Posted
August 20, 2014
Last Updated
June 18, 2018
Sponsor
Johnson & Johnson Vision Care, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT02223754
Brief Title
Evaluation of an Investigational Multifocal Lens
Study Type
Interventional
2. Study Status
Record Verification Date
July 2016
Overall Recruitment Status
Completed
Study Start Date
August 2014 (undefined)
Primary Completion Date
November 2014 (Actual)
Study Completion Date
November 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
The purpose of this study is to test the performance of an investigational multifocal test soft contact lens.
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
371 (Actual)
8. Arms, Groups, and Interventions
Arm Title
lotrafilcon B / etafilcon A
Arm Type
Active Comparator
Arm Description
Subject randomized to this sequence will first be dispensed the lotrafilcon B contact lens and then the etafilcon A contact lens.
Arm Title
etafilcon A / lotrafilcon B
Arm Type
Experimental
Arm Description
Subject randomized to this sequence will first be dispensed the etafilcon A contact lens and then the lotrafilcon B contact lens.
Intervention Type
Device
Intervention Name(s)
lotrafilcon B
Other Intervention Name(s)
AirOptix Aqua Multifocal
Intervention Description
Soft contact lens to be worn as daily wear, monthly replacement modality.
Intervention Type
Device
Intervention Name(s)
etafilcon A
Intervention Description
Soft contact lens to be worn as daily wear, daily disposable modality.
Primary Outcome Measure Information:
Title
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
Title
Distance Binocular Visual Acuity (LogMAR)
Description
Distance time controlled LogMAR Visual Acuity was carried out binocularly with high luminance and high contrast.
Time Frame
8- 12 Days post wear
Title
Intermediate Binocular Visual Acuity (LogMAR)
Description
Intermediate time controlled LogMAR Visual Acuity was carried out binocularly using High lumiance and High Contrast.
Time Frame
8-12 days post wear
Title
Near Binocular Visual Acuity (LogMAR)
Description
Near time controlled LogMAR Visual Acuity was carried out binocularly using High lumiance and High Contrast.
Time Frame
8-12 days post wear
Title
Corneal Staining
Description
Corneal staining is evaluated 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 staining, and those subjects with less than Grade 3. Below the percentage of subject eyes with grade 3 or higher is reported for each lens.
Time Frame
8 - 12 Days post wear
Title
Bulbar Conjunctival Injection
Description
The bulbar is the scelra. Bulbar Conjunctival Injection was assessed 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. Below the percentage of subject eyes with grade 3 or higher is reported for each lens.
Time Frame
8- 12 Days post wear
Title
Limbal Conjunctival Injection
Description
The Limbus is the 1 to 2mm wide zone of conjunctiva and underlying tissue adjacent to where the cornea joins the sclera. Limbal Conjunctival Injection was assesed 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 Conjunctival injection, and those subjects with less than Grade 3. Below the percentage of subject eyes with grade 3 or higher is reported for each lens.
Time Frame
8- 12 Days post wear
Title
Contact Lens Fitting
Description
Contact Lens fitting is reported as a binary response. Yes- acceptable lens fit, No- unacceptable lens fit. The percentage of subject eyes with acceptable fit is reported.
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:
The subjects were required to have read, understand, and signed 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.
Between 40 and 70 years of age.
Subjects must own a wearable pair of spectacles, if required for their distance vision.
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 of more duration)
Already be wearing a presbyopic contact lens correction (e.g., reading spectacles over contact lenses, multifocal or monovision contact lenses, etc.) or if not respond positively to at least one symptom on the "Presbyopic Symptoms Questionnaire"*
The subject's vertex corrected spherical equivalent distance refraction was required to be in the range +3.50 to -5.75 in each eye.
Refractive cylinder ≤ -0.75 D in each eye.
ADD power in the range +0.75 D to +2.50 D in each eye.
Best corrected visual acuity of 20/20-3 or better in each eye.
Exclusion Criteria:
Currently pregnant or lactating (subjects who became pregnant during the study were discontinued).
Any ocular or systemic allergies that may have contraindicated contact lens wear.
Any ocular or systemic disease, autoimmune disease, or use of medication, that may have contraindicated contact lens wear.
Any ocular abnormality that may have interfered 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.).
History of herpetic keratitis.
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.
Participation in any contact lens or lens care product clinical trial within 30 days prior to study enrollment.
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 or inflammation.
Any corneal distortion or irregular cornea.
Facility Information:
City
Montgomery
State/Province
Alabama
ZIP/Postal Code
36109
Country
United States
City
Mission Viejo
State/Province
California
ZIP/Postal Code
92691
Country
United States
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32205
Country
United States
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32250
Country
United States
City
Orange Park
State/Province
Florida
ZIP/Postal Code
32065
Country
United States
City
Saint Augustine
State/Province
Florida
ZIP/Postal Code
32092
Country
United States
City
Tallahassee
State/Province
Florida
ZIP/Postal Code
32308
Country
United States
City
Tampa
State/Province
Florida
ZIP/Postal Code
33625
Country
United States
City
Winter Park
State/Province
Florida
ZIP/Postal Code
32792
Country
United States
City
Roswell
State/Province
Georgia
ZIP/Postal Code
30076
Country
United States
City
Pittsburg
State/Province
Kansas
ZIP/Postal Code
66762
Country
United States
City
East Lansing
State/Province
Michigan
ZIP/Postal Code
48823
Country
United States
City
Vestal
State/Province
New York
ZIP/Postal Code
13850
Country
United States
City
Denver
State/Province
North Carolina
ZIP/Postal Code
28037
Country
United States
City
Powell
State/Province
Ohio
ZIP/Postal Code
43065
Country
United States
City
Springfield
State/Province
Ohio
ZIP/Postal Code
45503
Country
United States
City
Warwick
State/Province
Rhode Island
ZIP/Postal Code
02888
Country
United States
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38119
Country
United States
City
Tyler
State/Province
Texas
ZIP/Postal Code
75701
Country
United States
City
Salem
State/Province
Virginia
ZIP/Postal Code
24153
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Evaluation of an Investigational Multifocal Lens
We'll reach out to this number within 24 hrs