Expired Study
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Berkeley, California 94704


Purpose:

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


Study summary:

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.


Criteria:

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 (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 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


NCT ID:

NCT02341859


Primary Contact:

Principal Investigator
Meng C Lin, OD PhD
CRC-UC Berkeley


Backup Contact:

N/A


Location Contact:

Berkeley, California 94704
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: November 17, 2017

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