Evaluation of DW Silicone Hydrogel Lens Compared to DW Silicone Hydrogel Lens

Stopped early · Not applicable

Conditions studied: Myopia

In brief

The purpose of this study is to evaluate the performance of the investigational CooperVision silicone hydrogel lens compared to a currently-marketed silicone hydrogel contact lens up to 30 days of daily lens wear.

Key facts

Study ID

NCT01386008

Run by

CooperVision, Inc.

People needed

28

Starts

2011-05-01

Expected to finish

2011-06-01

Last updated by the study team

2019-09-04

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Be at least 18 years of age as of the date of evaluation for the study.
• Not using any ocular medications
• Have a self-reported full eye examination within 2 years.
• Have:
• read the Informed Consent
• be given an explanation of the Informed Consent
• indicate 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 0.75 diopter of refractive astigmatism in order to have the best spherical equivalent power of -6.50 or less.
• Be willing to wear contact lenses in both eyes.
• Have manifest refraction Snellen visual acuities (VA) equal to or better than 20/25 (less than or equal to LogMAR 0.10) 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…

• 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.
• Any active participation in another one-day clinical trial within 7 days prior to this study or another dispensing 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 month.
• Has a known sensitivity to ingredients used in the over the counter contact lens care approved for use in the study.
• Previous refractive surgery/anterior segment surgery; or current or previous orthokeratology treatment or irregular cornea.
• Is aphakic or pseudophakic.
• Unable to achieve a satisfactory fit with the lens designs used in the study
• 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 contradict contact lens wear or which would require the lenses to be removed during the day.
• The presence of clinically anterior segment infection, inflammations or abnormalities; such as iritis; or any infection of the eye, lids, or associated structures.
• A history of herpetic keratitis.
• A known history of corneal hypoesthesia (reduced corneal sensitivity) or active corneal ulcer, corneal infiltrates or fungal infection.
• 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
• Corneal edema or corneal staining ≥ grade 2
• Neovascularization or ghost vessels > 1.0 mm in from the limbus
• Giant papillary conjunctivitis (GPC) of > grade 2.
• Seborrheic eczema, seborrheic conjunctivitis or blepharitis

Where it is running

• Clinical Research Center, University of California, Berkeley — Berkeley, California, United States
• University of Manchester — Manchester, United Kingdom

Full record on ClinicalTrials.gov

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