Clinical Evaluation Of Two Daily Disposable Contact Lenses And A Monthly Replacement Lens

NCT01151371 | Completed Results

• 1 other identifier: CR-0917
• Study Type: interventional
• Target: 452
• Locations: 1 country
• Sites: 28

Brief Summary

The objective of the study is to compare the clinical performance of silicone hydrogel daily disposable contact lenses, conventional hydrogel daily disposable contact lenses and silicone hydrogel monthly replacement contact lenses.

Conditions

Myopia

Outcome Measures

Primary Outcomes (4)

• Overall Comfort Narafilcon B v. Nelfilcon A

  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 1 week

• Signs of Limbal Hyperemia Narafilcon B v. Nelfilcon A

  Redness scale of 0 to 4, where 0=None, 4=Severe redness

  After 1 Week

• Subjective Rating of Overall Comfort Narafilcon B v. Lotrafilcon B

  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 4 Weeks

• Signs of Limbal Hyperemia Narafilcon B v. Lotrafilcon B

  Redness scale of 0 to 4, where 0=None, and 4=Severe.

  After 4 Weeks

Secondary Outcomes (8)

• Signs of Inferior Corneal Staining Narafilcon B v. Nelfilcon A

  After 1 Week

• Subjective Rating of Overall Ease of Lens Handling Narafilcon B v Nelfilcon A

  After 1 Week

• Subjective Rating of End of Day Comfort Narafilcon B v. Nelfilcon A

  After 1 Week

• Subjective Rating of Initial Comfort Narafilcon B v. Nelfilcon A

  After 1 Week

• Signs of Inferior Corneal Staining Narafilcon B v. Lotrafilcon B

  After 4 Weeks

Study Arms (3)

narafilcon B daily disposable 4 weeks

EXPERIMENTAL

narafilcon B soft contact lenses worn daily on a daily disposable/replacement schedule, for 4 weeks

Device: narafilcon B contact lens

nelfilcon A daily disponsable 1 week

ACTIVE COMPARATOR

nelfilcon A soft contact lenses worn daily on a daily disposable/replacement schedule, for 1 week

Device: nelfilcon A contact lens

lotrafilcon B daily wear, monthly replacement, 4-weeks

ACTIVE COMPARATOR

lotrafilcon B soft contact lenses worn daily on a 1-month replacement schedule, for 4 weeks

Device: lotrafilcon B contact lens

Interventions

narafilcon B contact lens DEVICE

Silicone Hydrogel Daily Disposable Contact Lenses

narafilcon B daily disposable 4 weeks

nelfilcon A contact lens DEVICE

Conventional Hydrogel Daily Disposable Contact Lenses

nelfilcon A daily disponsable 1 week

lotrafilcon B contact lens DEVICE

Silicone Hydrogel Monthly Replacement Contact Lenses

lotrafilcon B daily wear, monthly replacement, 4-weeks

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 (See separate document).
• Be willing and able to adhere to the instructions set out in the protocol.
• Own a cell phone and be willing to receive text messages during the day.
• Be an existing successful daily wear soft contact lens. 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 vertexed spherical contact lens prescription between -1.00 and -6.00D.
• Have refractive astigmatism less than or equal to 1.00D in both eyes.
• Achieve visual acuity of 6/9 (20/30) or better in each eye.
• Require a visual correction in both eyes (no monofit or monovision allowed).
• Does not require presbyopic correction (i.e. Not using any presbyopic correction and measured add power of less than +1.00D).
• 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.

You may not qualify if:

• Requires concurrent ocular medication.
• Clinically significant (Grade 3 or 4) 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 (Grade 3 in more than one corneal region per eye).
• Requires presbyopic correction (i.e. Not using any presbyopic correction and measured add power of less than +1.00D).
• Has had refractive surgery.
• Has had eye injury/surgery within 8 weeks immediately prior to enrolment for this study.
• Abnormal lacrimal secretions.
• Pre-existing ocular irritation that would preclude contact lens fitting.
• Keratoconus or other corneal irregularity.
• PMMA(polymethyl methacrylate), hybrid or RGP(rigid gas permeable) lens wear in the previous 8 weeks.
• Does not require presbyopic correction (i.e. Not using any presbyopic correction and measured add power of less than +1.00D).
• 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., HIV (Human immunodeficiency virus)).
• History of chronic eye disease (e.g. glaucoma or ARMD (age related macular degeneration)).

Sponsors & Collaborators

• Johnson & Johnson Vision Care, Inc.: lead
• Visioncare Research Ltd.: collaborator

Study Sites (28)

Unknown Facility

Brea, California, United States

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Canoga Park, California, United States

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Corona, California, United States

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Bridgeport, Connecticut, United States

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Jacksonville, Florida, 32205, United States

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Jacksonville, Florida, 32256, United States

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Tampa, Florida, United States

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Winter Park, Florida, United States

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Roswell, Georgia, United States

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Mishawaka, Indiana, United States

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Boston, Massachusetts, United States

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Blue Springs, Missouri, United States

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Independence, Missouri, United States

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Lake Ozark, Missouri, United States

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New York, New York, United States

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Raleigh, North Carolina, United States

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Chagrin Falls, Ohio, United States

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North Olmsted, Ohio, United States

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Warren, Ohio, United States

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Kittanning, Pennsylvania, United States

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State College, Pennsylvania, United States

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Warwick, Rhode Island, United States

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Bartlett, Tennessee, United States

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Brentwood, Tennessee, United States

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Tyler, Texas, 75701, United States

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Tyler, Texas, 75703, United States

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Burlington, Vermont, United States

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Virginia Beach, Virginia, United States

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MeSH Terms

Conditions

Myopia

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases

Results Point of Contact

• Title: Kathy Lorenz-Osborn, OD
• Organization: Vistakon

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: March 24, 2010
• First Posted: June 28, 2010
• Study Start: February 1, 2010
• Primary Completion: April 1, 2010
• Study Completion: April 1, 2010
• Last Updated: June 19, 2018
• Results First Posted: December 19, 2011

Record last verified: 2017-08

Locations

US (28)