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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Johnson & Johnson Vision Care, Inc.
ClinicalTrials.gov Identifier:
NCT01763047
First received: December 17, 2012
Last updated: May 3, 2016
Last verified: May 2016
  Purpose
The objective of this study is to evaluate the performance of a novel multifocal lens system.

Condition Intervention
Presbyopia
Device: etafilcon A
Device: lotrafilcon B

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Johnson & Johnson Vision Care, Inc.:

Primary Outcome Measures:
  • Binocular Distance Visual Acuity (LogMAR) [ Time Frame: 8-12 days post wear ] [ Designated as safety issue: No ]
    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) [ Time Frame: 8-12 days post wear ] [ Designated as safety issue: No ]
    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 [ Time Frame: 8-12 days post wear ] [ Designated as safety issue: No ]
    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 [ Time Frame: 8-12 days post wear ] [ Designated as safety issue: No ]
    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 [ Time Frame: 8-12 days post wear ] [ Designated as safety issue: No ]
    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 [ Time Frame: 8-12 days post wear ] [ Designated as safety issue: No ]
    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).


Enrollment: 298
Study Start Date: November 2012
Study Completion Date: February 2013
Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: etafilcon A/lotrafilcon B
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.
Device: etafilcon A
To be worn in a daily wear modality for a minimum of 6 hours per day.
Device: lotrafilcon B
Lenses will be worn in a reuseable modality; cleaned and disinfected each night.
Other Name: AirOptix Aqua Multifocal
Active Comparator: lotrafilcon B/etafilcon A
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.
Device: etafilcon A
To be worn in a daily wear modality for a minimum of 6 hours per day.
Device: lotrafilcon B
Lenses will be worn in a reuseable modality; cleaned and disinfected each night.
Other Name: AirOptix Aqua Multifocal

  Eligibility

Ages Eligible for Study:   40 Years to 70 Years   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01763047

Locations
United States, California
Mission Viejo, California, United States
United States, Florida
RPS
Jacksonville, Florida, United States
Jacksonville, Florida, United States
St. Augustine, Florida, United States
Tallahassee, Florida, United States
Winter Park, Florida, United States
United States, Georgia
Roswell, Georgia, United States
United States, Maryland
Lutherville, Maryland, United States
United States, New Jersey
Closter, New Jersey, United States
United States, New York
New York, New York, United States
United States, North Carolina
Denver, North Carolina, United States
United States, Ohio
Athens, Ohio, United States
United States, Pennsylvania
Kingston, Pennsylvania, United States
United States, Rhode Island
Warwick, Rhode Island, United States
United States, Tennessee
Memphis, Tennessee, United States
United States, Texas
Amarillo, Texas, United States
Tyler, Texas, United States
United States, Utah
Salt Lake City, Utah, United States
United States, Virginia
Salem, Virginia, United States
Sponsors and Collaborators
Johnson & Johnson Vision Care, Inc.
  More Information

Responsible Party: Johnson & Johnson Vision Care, Inc.
ClinicalTrials.gov Identifier: NCT01763047     History of Changes
Other Study ID Numbers: CR-5357 
Study First Received: December 17, 2012
Results First Received: March 1, 2016
Last Updated: May 3, 2016
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Presbyopia
Refractive Errors
Eye Diseases

ClinicalTrials.gov processed this record on August 25, 2016