Clinical Evaluation of Stenfilcon A Soft Contact Lens When Compared to Ocufilcon B Soft Contact Lens

Completed · Not applicable

Conditions studied: Myopia

In brief

This study seeks to evaluate a new daily disposable contact lens compared to an existing daily disposable contact lens.

Key facts

Study ID

NCT01354223

Run by

CooperVision, Inc.

People needed

90

Starts

2010-10-01

Expected to finish

2011-04-01

Last updated by the study team

2020-07-29

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Prior to being considered eligible to participate in this study, each subject MUST:
• Be at least 18 years of age as of the date of evaluation for the study.
• Have:
• Read the Informed Consent
• been given an explanation of the Informed Consent
• indicated understanding of the Informed Consent
• signed the Informed Consent document.
• Be willing and able to adhere to the instructions set forth in this protocol and able to keep all specified appointments.
• Be an adapted, current full-time silicone hydrogel or soft contact lens wearer. An adapted full-time wearer is defined as wearing contact lenses on a daily basis for at least 8 hours per day for at least one month prior to participation in the study.
• Possess wearable and visually functional eyeglasses.
• Be in good general health, based on his/her knowledge.
• Require spectacle lens powers between -1.00 and -6.00 diopters sphere with no more than 1.00 diopter of refractive astigmatism and be willing to wear contact lenses in both eyes.
• Have manifest refraction Snellen visual acuities (VA) equal to or better than 20/25 in each eye.
• Upon completing the fitting process with the lenses to be worn in the study, have contact lens Snellen VA equal to or better than 20/30 in each eye.

You may not qualify if…

• Subjects may not be enrolled in this study if any of the following apply: The subject is/has:
• Wearing lenses in a monovision modality and is unwilling to be fit with distance lenses in both eyes. NOTE: Subjects may not wear lenses in a monovision modality at any time during the study as it will interfere with the visual acuity analysis.
• Poor personal hygiene.
• Any active participation in another clinical trial within 30 days prior to this study.
• Currently pregnant (to the best of the subject's knowledge), is lactating or is planning a pregnancy within the next 3 months.
• A member, relative or household member of the investigator or of the investigational office staff.
• Has a known sensitivity to ingredients used in the over the counter contact lens lubricants approved for use in the study.
• Previous refractive surgery; or current or previous orthokeratology treatment.
• Is aphakic or psuedophakic.
• Ocular or systemic disease such as, but not limited to: anterior uveitis or iritis (past or present), glaucoma, Sjögren's syndrome, lupus erythematosus, sclerodermia, keratoconus or type II diabetes.
• The need for topical ocular medications or any medication which might interfere with contact lens wear or which would require the lenses to be removed during the day.
• The presence of clinically significant (grade 3 or 4) anterior segment abnormalities; inflammations such as iritis; or any infection of the eye, lids, or associated structures.
• A known history of corneal hypoesthesia (reduced corneal sensitivity), corneal ulcer, corneal infiltrates or fungal infections.
• A history of papillary conjunctivitis that has interfered with contact lens wear.
• Slit lamp findings that would contraindicate contact lens wear, including but not limited to:
• Pathological dry eye or associated dry eye symptoms with decreased tear levels and punctuate staining > Grade 2
• Pterygium
• Corneal scars within the visual axis
• Neovascularization or ghost vessels > 1.0 mm in from the limbus
• Giant papillary conjunctivitis (GPC) of > Grade 2
• Anterior uveitis or iritis
• Seborrheic eczema, seborrheic conjunctivitis or blepharitis
• To be eligible to be randomized for study product a subject must have ALL of the Inclusion Criteria and have NONE of the exclusion criteria present.
• To be eligible for lens dispensing (either Test or Control), the subject's study lens contact lens visual acuity must be equal to or better than 20/30 in each eye.

Where it is running

• Eric M. White, OD, Inc. — San Diego, California, United States
• Vision Care Associates — East Lansing, Michigan, United States
• Western Reserve Vision Care — Beachwood, Ohio, United States
• Primary Eyecare Group, P.C. — Brentwood, Tennessee, United States

Full record on ClinicalTrials.gov

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