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

NCT ID: NCT01151371

Last Updated: 2018-06-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 452 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-02-01
• Study Completion Date: 2010-04-01

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

narafilcon B daily disposable 4 weeks

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

Group Type: EXPERIMENTAL

narafilcon B contact lens

Intervention Type: DEVICE

Silicone Hydrogel Daily Disposable Contact Lenses

nelfilcon A daily disponsable 1 week

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

Group Type: ACTIVE_COMPARATOR

nelfilcon A contact lens

Intervention Type: DEVICE

Conventional Hydrogel Daily Disposable Contact Lenses

lotrafilcon B daily wear, monthly replacement, 4-weeks

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

Group Type: ACTIVE_COMPARATOR

lotrafilcon B contact lens

Intervention Type: DEVICE

Silicone Hydrogel Monthly Replacement Contact Lenses

Interventions

narafilcon B contact lens

Silicone Hydrogel Daily Disposable Contact Lenses

Intervention Type: DEVICE

nelfilcon A contact lens

Conventional Hydrogel Daily Disposable Contact Lenses

Intervention Type: DEVICE

lotrafilcon B contact lens

Silicone Hydrogel Monthly Replacement Contact Lenses

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• 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.
• No clinically significant slit lamp findings (i.e. stromal edema, vascularization, infiltrates or abnormal opacities).
• No other active ocular disease.

Exclusion Criteria

• 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)).
• Pregnancy, lactating or planning a pregnancy at the time of enrolment.
• Participation in any concurrent clinical trial or in last 30 days.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 39 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Visioncare Research Ltd.

OTHER

Sponsor Role: collaborator

Johnson & Johnson Vision Care, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Brea, California, United States

Canoga Park, California, United States

Corona, California, United States

Bridgeport, Connecticut, United States

Jacksonville, Florida, United States

Jacksonville, Florida, United States

Tampa, Florida, United States

Winter Park, Florida, United States

Roswell, Georgia, United States

Mishawaka, Indiana, United States

Boston, Massachusetts, United States

Blue Springs, Missouri, United States

Independence, Missouri, United States

Lake Ozark, Missouri, United States

New York, New York, United States

Raleigh, North Carolina, United States

Chagrin Falls, Ohio, United States

North Olmsted, Ohio, United States

Warren, Ohio, United States

Kittanning, Pennsylvania, United States

State College, Pennsylvania, United States

Warwick, Rhode Island, United States

Bartlett, Tennessee, United States

Brentwood, Tennessee, United States

Tyler, Texas, United States

Tyler, Texas, United States

Burlington, Vermont, United States

Virginia Beach, Virginia, United States

Countries

United States

Other Identifiers

CR-0917

Identifier Type: -

Identifier Source: org_study_id