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Evaluation of an Investigational Multifocal Lens

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ClinicalTrials.gov Identifier: NCT02223754
Recruitment Status : Completed
First Posted : August 22, 2014
Results First Posted : August 31, 2016
Last Update Posted : June 19, 2018
Sponsor:
Information provided by (Responsible Party):
Johnson & Johnson Vision Care, Inc.

Brief Summary:
The purpose of this study is to test the performance of an investigational multifocal test soft contact lens.

Condition or disease Intervention/treatment Phase
Presbyopia Device: lotrafilcon B Device: etafilcon A Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 371 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : August 2014
Actual Primary Completion Date : November 2014
Actual Study Completion Date : November 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eye Wear

Arm Intervention/treatment
Active Comparator: lotrafilcon B / etafilcon A
Subject randomized to this sequence will first be dispensed the lotrafilcon B contact lens and then the etafilcon A contact lens.
Device: lotrafilcon B
Soft contact lens to be worn as daily wear, monthly replacement modality.
Other Name: AirOptix Aqua Multifocal

Device: etafilcon A
Soft contact lens to be worn as daily wear, daily disposable modality.

Experimental: etafilcon A / lotrafilcon B
Subject randomized to this sequence will first be dispensed the etafilcon A contact lens and then the lotrafilcon B contact lens.
Device: lotrafilcon B
Soft contact lens to be worn as daily wear, monthly replacement modality.
Other Name: AirOptix Aqua Multifocal

Device: etafilcon A
Soft contact lens to be worn as daily wear, daily disposable modality.




Primary Outcome Measures :
  1. Overall Quality of Vision Using the Contact Lens User Experience (CLUE) TM Questionnaire [ Time Frame: 8 -12 days post wear ]
    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).

  2. Distance Binocular Visual Acuity (LogMAR) [ Time Frame: 8- 12 Days post wear ]
    Distance time controlled LogMAR Visual Acuity was carried out binocularly with high luminance and high contrast.

  3. Intermediate Binocular Visual Acuity (LogMAR) [ Time Frame: 8-12 days post wear ]
    Intermediate time controlled LogMAR Visual Acuity was carried out binocularly using High lumiance and High Contrast.

  4. Near Binocular Visual Acuity (LogMAR) [ Time Frame: 8-12 days post wear ]
    Near time controlled LogMAR Visual Acuity was carried out binocularly using High lumiance and High Contrast.

  5. Corneal Staining [ Time Frame: 8 - 12 Days post wear ]
    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.

  6. Bulbar Conjunctival Injection [ Time Frame: 8- 12 Days post wear ]
    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.

  7. Limbal Conjunctival Injection [ Time Frame: 8- 12 Days post wear ]
    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.

  8. Contact Lens Fitting [ Time Frame: 8- 12 Days post wear ]
    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.



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Ages Eligible for Study:   40 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. The subjects were required to have read, understand, and signed 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. Between 40 and 70 years of age.
  4. Subjects must own a wearable pair of spectacles, if required for their distance vision.
  5. 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)
  6. 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"*
  7. The subject's vertex corrected spherical equivalent distance refraction was required to be in the range +3.50 to -5.75 in each eye.
  8. Refractive cylinder ≤ -0.75 D in each eye.
  9. ADD power in the range +0.75 D to +2.50 D in each eye.
  10. Best corrected visual acuity of 20/20-3 or better in each eye.

Exclusion Criteria:

  1. Currently pregnant or lactating (subjects who became pregnant during the study were discontinued).
  2. Any ocular or systemic allergies that may have contraindicated contact lens wear.
  3. Any ocular or systemic disease, autoimmune disease, or use of medication, that may have contraindicated contact lens wear.
  4. Any ocular abnormality that may have interfered 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, PRK, LASIK, etc.).
  7. History of herpetic keratitis.
  8. History of binocular vision abnormality or strabismus.
  9. Any infectious disease (e.g., hepatitis, tuberculosis) or a contagious immunosuppressive disease (e.g., HIV).
  10. History of diabetes.
  11. Participation in any contact lens or lens care product clinical trial within 30 days prior to study enrollment.
  12. 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.
  13. Any ocular infection or inflammation.
  14. Any corneal distortion or irregular cornea.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02223754


Locations
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United States, Alabama
Montgomery, Alabama, United States, 36109
United States, California
Mission Viejo, California, United States, 92691
United States, Florida
Jacksonville, Florida, United States, 32205
Jacksonville, Florida, United States, 32250
Orange Park, Florida, United States, 32065
Saint Augustine, Florida, United States, 32092
Tallahassee, Florida, United States, 32308
Tampa, Florida, United States, 33625
Winter Park, Florida, United States, 32792
United States, Georgia
Roswell, Georgia, United States, 30076
United States, Kansas
Pittsburg, Kansas, United States, 66762
United States, Michigan
East Lansing, Michigan, United States, 48823
United States, New York
Vestal, New York, United States, 13850
United States, North Carolina
Denver, North Carolina, United States, 28037
United States, Ohio
Powell, Ohio, United States, 43065
Springfield, Ohio, United States, 45503
United States, Rhode Island
Warwick, Rhode Island, United States, 02888
United States, Tennessee
Memphis, Tennessee, United States, 38119
United States, Texas
Tyler, Texas, United States, 75701
United States, Virginia
Salem, Virginia, United States, 24153
Sponsors and Collaborators
Johnson & Johnson Vision Care, Inc.

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Responsible Party: Johnson & Johnson Vision Care, Inc.
ClinicalTrials.gov Identifier: NCT02223754     History of Changes
Other Study ID Numbers: CR-5593
First Posted: August 22, 2014    Key Record Dates
Results First Posted: August 31, 2016
Last Update Posted: June 19, 2018
Last Verified: July 2016
Additional relevant MeSH terms:
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Presbyopia
Refractive Errors
Eye Diseases