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



Status:Completed
Conditions:Ocular
Therapuetic Areas:Ophthalmology
Healthy:No
Age Range:18 - 40
Updated:4/21/2016
Start Date:January 2015
End Date:July 2015

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

The aim of this non-dispensing study is to evaluate the fitting performance of MyDay™ 8.4
base curve, especially for flatter corneas, and compared it with 1-DAY ACUVUE® TruEye® 9.0
base curve and DAILIES TOTAL1® 8.8 base curve in a range of spherical powers.

Inclusion Criteria:

- 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 (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

Exclusion Criteria:

- 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
We found this trial at
1
site
7 Gauss Way
Berkeley, California 94704
?
mi
from
Berkeley, CA
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