Multi-Center 2-Week Clinical Evaluation of Three Silicone Hydrogel Contact Lenses

NCT01244516 | Completed Results

• 1 other identifier: CR-201007
• Study Type: interventional
• Target: 540
• Locations: 1 country
• Sites: 35

Brief Summary

The purpose of this study is to compare the clinical performance of three silicone hydrogel contact lenses over a 2 week period.

Conditions

Myopia

Outcome Measures

Primary Outcomes (2)

• Overall Subjective Comfort

  Contact Lens User Experience (CLUE)TM questionnaire: 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.

  after 2 weeks of contact lens wear

• Corneal Staining

  Investigator evaluated corneal staining. Percent of eyes with corneal staining presence or absence is evaluated.

  after 2 weeks of contact lens wear

Secondary Outcomes (1)

• Overall Subjective Lens Handling

  after 2 weeks of contact lens wear

Study Arms (3)

galyfilcon A

OTHER

Subjects that were randomized to receive the galyfilcon A lens with a base curve of 8.30 throughout the entire course of the study.

Device: galyfilcon A, BC 8.30

lotrafilcon B

OTHER

Subjects that were randomized to wear lotrafilcon B lens throughout the course of the study.

Device: lotrafilcon B, BC 8.60

comfilcon A

OTHER

Subjects that were randomized to wear comfilcon A lens throughout the course of the study.

Device: comfilcon A, BC 8.60

Interventions

galyfilcon A, BC 8.30 DEVICE

galyfilcon A, BC 8.30 soft contact lens

galyfilcon A

lotrafilcon B, BC 8.60 DEVICE

lotrafilcon B, BC 8.60 soft contact lens

lotrafilcon B

comfilcon A, BC 8.60 DEVICE

comfilcon A, BC 8.60 soft contact lens

comfilcon A

Eligibility Criteria

• Age: 18 Years - 39 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Be no less than 18 and no more than 39 years of age.
• Sign Written Informed Consent and investigator to record this on Case Report Form.
• Be willing and able to adhere to the instructions set out in the protocol.
• Be an existing successful daily wear soft contact lens wearer. For the purposes of this study this means wearing lenses for at least 6 hours per day, 5 days per week for the last month.
• No extended wear in the last 3 months.
• Subjective refraction must result in a vertex corrected spherical contact lens prescription between -1.00 and -6.00 diopters.
• Have refractive astigmatism less than or equal to 1.00 diopters (D) in both eyes.
• Achieve visual acuity of 6/9 (20/30) or better in each eye.
• Require a visual correction in both eyes (no monovision allowed).
• Have normal eyes with no evidence of abnormality or disease. For the purposes of this study a normal eye is defined as one having: no amblyopia, no evidence of lid abnormality or infection (including blepharitis/meibomitis), no conjunctival abnormality or infection, no clinically significant slit lamp findings (i.e. stromal edema, vascularization, infiltrates or abnormal opacities), no other active ocular disease.

You may not qualify if:

• Requires concurrent ocular medication.
• Clinically significant corneal stromal haze, corneal vascularization, tarsal abnormalities, bulbar hyperemia, limbal hyperemia, or any other abnormality of the cornea that would contraindicate contact lens wear.
• Clinically significant corneal staining
• Requires presbyopic correction (i.e. Not using any presbyopic correction and measured add power of less than +1.00 diopters).
• Has had refractive surgery.
• Has had eye injury/surgery within 8 weeks immediately prior to enrollment for this study.
• Abnormal lacrimal secretions.
• Pre-existing ocular irritation that would preclude contact lens fitting.
• Keratoconus or other corneal irregularity.
• Hard, hybrid or Rigid Gas Permeable lens wear in the previous 8 weeks.
• Any systemic illness which would contraindicate lens wear or the medical treatment of which would affect vision or successful lens wear.
• Diabetic.
• Infectious disease (e.g., hepatitis, tuberculosis) or an immunosuppressive disease \[e.g., Human immunodeficiency virus (HIV)\].
• History of chronic eye disease (e.g. glaucoma or Age Related Macular Degeneration).
• Pregnancy, lactating or planning a pregnancy at the time of enrollment.

Sponsors & Collaborators

• Johnson & Johnson Vision Care, Inc.: lead

Study Sites (35)

Unknown Facility

Brea, California, 92891, United States

Location

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Campbell, California, 95008, United States

Location

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Cupertino, California, 95014, United States

Location

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Mission Viejo, California, 92691, United States

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Colorado Springs, Colorado, 80909, United States

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Bridgeport, Connecticut, 06610, United States

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Aventura, Florida, 33180, United States

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Jacksonville, Florida, 32256, United States

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Tallahassee, Florida, 32308, United States

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Tampa, Florida, 33625, United States

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Winter Park, Florida, 32792, United States

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Roswell, Georgia, 30076, United States

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Bloomington, Illinois, 61701, United States

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Mishawaka, Indiana, 46545, United States

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Pittsburg, Kansas, 66763, United States

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Boston, Massachusetts, 02114, United States

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Independence, Missouri, 64055, United States

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Raytown, Missouri, 64133, United States

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Closter, New Jersey, 07624, United States

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New York, New York, 10001, United States

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Raleigh, North Carolina, 27615, United States

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North Olmsted, Ohio, 44070, United States

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Powell, Ohio, 43065, United States

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Kittanning, Pennsylvania, 16201, United States

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Warwick, Rhode Island, 02888, United States

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Chamberlain, South Dakota, 57325, United States

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Bartlett, Tennessee, 38134, United States

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Brentwood, Tennessee, 37027, United States

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Memphis, Tennessee, 38119, United States

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Tyler, Texas, 75701, United States

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Tyler, Texas, 75703, United States

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Salt Lake City, Utah, 84106, United States

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Burlington, Vermont, 05401, United States

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Salem, Virginia, 24153, United States

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Unknown Facility

Virginia Beach, Virginia, 23455, United States

Location

MeSH Terms

Conditions

Myopia

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases

Results Point of Contact

• Title: Kathy Osborn, OD
• Organization: Johnson & Johnson Vision Care

KOsborn@its.jnj.com

1-904-443-1032

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 17, 2010
• First Posted: November 19, 2010
• Study Start: September 1, 2010
• Primary Completion: November 1, 2010
• Study Completion: November 1, 2010
• Last Updated: June 19, 2018
• Results First Posted: January 24, 2012

Record last verified: 2018-04

Locations

US (35)