Lens Fitting Evaluation of CooperVision MyDay™ Compared With 1-DAY ACUVUE® TruEye® and DAILIES TOTAL1®

Completed · Not applicable

Conditions studied: Myopia

In brief

Lens Fitting Evaluation of CooperVision MyDay™ Compared with 1-DAY ACUVUE® TruEye® and DAILIES TOTAL1®

Key facts

Study ID

NCT02341859

Run by

CooperVision, Inc.

People needed

22

Starts

2015-01-01

Expected to finish

2015-07-01

Last updated by the study team

2017-03-10

Who can join

Age: 18 and older, up to 40. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Is between 18 and 40 years of age (inclusive)
• Has had a self-reported visual exam in the last two years
• Is an adapted soft spherical contact lens wearer
• Has a contact lens spherical prescription between -4.00 to - 6.00 and higher than -7.00D (Diopters) (inclusive)
• Has a BFS (Best Fit Sphere) that is higher than 8.2 measured and calculated by corneal topography
• Can achieve best corrected spectacle distance visual acuity of 20/25 (0.10 logMAR) or better in each eye
• Can achieve a distance visual acuity of 20/30 (0.18 logMAR) or better in each eye with the study contact lenses
• Has clear corneas and no active ocular disease
• Has read, understood and signed the information consent letter
• Patient contact lens refraction should fit within the available parameters of the study lenses
• Is willing to comply with the wear schedule
• Is willing to comply with the visit schedule

You may not qualify if…

• Is not a habitual wearer of soft spherical contact lenses
• Has a contact lens prescription outside the range of the available parameters of the study lenses
• Has a contact lens prescription outside the range of the inclusion power range
• Has a spectacle cylinder ≥1.00D of cylinder in either eye
• Has a history of not achieving comfortable contact lens wear (5 days per week; > 8 hours/day)
• Has contact lens best corrected distance vision worse than 20/25 (0.10 logMAR) in either eye
• Presence of clinically significant (grade > 2) anterior segment abnormalities
• Presence of ocular or systemic disease or need of medications which might interfere with contact lens wear
• Slit lamp findings that would contraindicate contact lens wear such as:
• Moderate to severe dry eye
• Pterygium, pinguecula, or corneal scars within the visual axis
• Neovascularization > 0.75 mm in from of the limbus
• Giant papillary conjunctivitis (GCP) worse than grade 1
• Anterior uveitis or iritis (past or present)
• Seborrheic eczema, Seborrheic conjunctivitis
• History of corneal ulcers or fungal infections
• Poor personal hygiene
• Has a known history of corneal hypoesthesia (reduced corneal sensitivity)
• Has aphakia, keratoconus or a highly irregular cornea
• Has Presbyopia or has dependence on spectacles for near work over the contact lenses
• Has undergone corneal refractive surgery
• Is participating in any other type of eye related clinical or research study

Where it is running

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

Full record on ClinicalTrials.gov

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