Clinical Performance Comparison of Two Contact Lenses

Clinical Evaluation of Two Silicone Hydrogel Frequent Replacement Contact Lenses

The purpose of this study is to compare the clinical performance of two contact lenses.

Study Overview

• Status: Completed
• Conditions: Myopia
• Intervention / Treatment: Device: senofilcon A; Device: lotrafilcon B

• Study Type: Interventional
• Enrollment (Actual): 379
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Arkansas
    • North Little Rock, Arkansas, United States, 72116
  • California
    • Campbell, California, United States, 95008
  • Colorado
    • Colorado Springs, Colorado, United States, 80909
  • Florida
    • Jacksonville, Florida, United States, 32205
    • Jacksonville, Florida, United States, 32256
    • Miami, Florida, United States, 33155
    • Winter Park, Florida, United States, 32792
  • Georgia
    • Roswell, Georgia, United States, 30076
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
    • Cambridge, Massachusetts, United States, 02140
  • Missouri
    • Blue Springs, Missouri, United States, 64015
  • New York
    • New York, New York, United States, 10001
  • Ohio
    • Chagrin Falls, Ohio, United States, 44023
    • North Olmsted, Ohio, United States, 44070
    • Warren, Ohio, United States, 44484
  • Pennsylvania
    • State College, Pennsylvania, United States, 16801
  • Rhode Island
    • Warwick, Rhode Island, United States, 02888
  • South Dakota
    • Chamberlain, South Dakota, United States, 57325
    • Hot Springs, South Dakota, United States, 57747
  • Tennessee
    • Bartlett, Tennessee, United States, 38134
    • Brentwood, Tennessee, United States, 37027
    • Memphis, Tennessee, United States, 38119
  • Texas
    • Tyler, Texas, United States, 757703
  • Vermont
    • Burlington, Vermont, United States, 05401
  • Wisconsin
    • West Allis, Wisconsin, United States, 53227

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Existing daily soft lens wearer.
• Require a distance visual correction in both eyes.
• Have a contact lens spherical distance refraction between -1.00D and -6.00D.
• Have refractive astigmatism less than or equal to 1.00D in both eyes.
• Achieve 20/30 or better corrected distance acuity.
• Have normal eyes with no evidence of abnormality or disease.

Exclusion Criteria:

• Requires presbyopic correction.
• Requires ocular medications.
• Grade 3 or 4 ocular abnormalities.
• Grade 3 corneal staining in more than one region.
• Has had refractive surgery.
• Any other injury or ocular surgery within 8 weeks prior to study enrollment.
• Has abnormal lacrimal secretions.
• Pre-existing ocular irritation that would preclude contact lens fitting.
• Has keratoconus or other corneal irregularity.
• Polymethyl methacrylate (PMMA), Hybrid or Rigid Gas Permeable (RGP) wear in the previous 8 weeks.
• Wears habitual contact lenses that are toric, multifocal or worn extended wear.
• Any systemic illness which would contraindicate lens wear or the medical treatment of would affect vision or successful lens wear.
• Diabetic.
• Infectious or immunosuppressive disease.
• History of chronic eye disease (e.g glaucoma or age related macular degeneration).
• Pregnancy, lactation or planning pregnancy at time of enrollment.
• Participation in any concurrent clinical trial or in another trial in the last 30 days.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: senofilcon A both eyes; soft contact lens worn daily for 2 weeks, with a 2-week replacement regimen.	Device: senofilcon A; soft contact lens, 2-week replacement indicated
ACTIVE_COMPARATOR: lotrafilcon B both eyes; soft contact lens worn daily for 4 weeks, with a 4-week replacement regimen	Device: lotrafilcon B; soft contact lens with a 4-week replacement indicated.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Average Corneal Staining	The overall score is the average of the total scores of each of five regions of the cornea. The minimum average score is 0 and the maximum average score is 3. Corneal surface abnormality as indicated by the severity of staining over five regions of the cornea (central, superior, inferior, nasal and temporal) was assessed by the investigator using the following scale: 0=none, 1=slight, 2=moderate, 3=severe.	2 weeks
Visual Acuity	Visual acuity was assessed by the investigator using the Snellen chart and converted to the logarithm of the minimum angle of resolution (logMAR). logMAR ideal is 0.0 and represents 20/20 Snellen visual acuity. logMAR values > 0.00 indicate vision poorer than the ideal and values <0.00 indicate vision greater than the ideal.	2 weeks
Overall Comfort	After two weeks of wear, subjects responded to a phone survey question regarding overall comfort of the study contact lenses (senofilcon A and lotrafilcon B) using the following scale: 5=excellent, 4=very good, 3=good, 2=fair, 1=poor.	2 weeks
Overall Comfort	After four weeks of wear, subjects responded to a phone survey question regarding overall comfort of the study contact lenses (lotrafilcon B)using the following scale: 5=excellent, 4=very good, 3=good, 2=fair, 1=poor.	2 weeks and 4 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Limbal Redness	The investigator assessed limbal redness using the following scale: 0=None, 1=Trace, 2=Mild, 3=Moderate, 4=Severe	2 weeks
Bulbar Redness	The investigator assessed bulbar redness using the following scale: 0=None, 1=Trace, 2=Mild, 3=Moderate, 4=Severe	2 weeks
Symptoms of Dryness	Subjects responded to a phone survey question regarding the frequency of the sensation of dryness while wearing the study contact lenses using the following scale: 1=Extreme, 2=Moderate, 3=Slight, 4=None	2 weeks

Collaborators and Investigators

• Sponsor: Johnson & Johnson Vision Care, Inc.
• Collaborators: Visioncare Research Ltd.
• Investigators: Study Director: Sheila, B Hickson-Curran, BSc, MCOptom, Johnson & Johnson Vision Care, Inc.

Study record dates

Study Major Dates

• Study Start (ACTUAL): August 1, 2009
• Primary Completion (ACTUAL): October 1, 2009
• Study Completion (ACTUAL): October 1, 2009

Study Registration Dates

• First Submitted: September 10, 2009
• First Submitted That Met QC Criteria: September 10, 2009
• First Posted (ESTIMATE): September 11, 2009

Study Record Updates

• Last Update Posted (ACTUAL): June 19, 2018
• Last Update Submitted That Met QC Criteria: June 18, 2018
• Last Verified: August 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors; Myopia
• Other Study ID Numbers: CR-0907; PHNX-518