CompletedNot Applicable

Evaluation of Two Toric Soft Contact Lenses After Two Weeks of Wear

96 participantsStarted 2007-09

Plain-language summary

The purpose of this study is to determine the relative performance of a new toric soft contact lens against a toric contact lens currently available in market, specifically with regards to the comfort and vision after two weeks of use.

Who can participate

Age range18 Years – 39 Years

SexALL

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Inclusion criteria

✓. be at least 18 and less than or equal to 39 years of age and have a need for vision correction in BOTH eyes (monovision or uniocular fitting is NOT allowed).
✓. be of Asian descent (Japanese, Chinese, Korean, Polynesian or other Asian ancestry) and have Asian Eye anatomy.
✓. have successfully worn toric or spherical soft (hydrogel or silicone hydrogel) contact lenses for at least 4-weeks prior to enrollment in the study.
✓. be able and willing to adhere to the instructions set forth in the protocol.
✓. agree to wear their contact lenses in both eyes on a daily wear schedule for at least 8 hours per day every day during the study.
✓. have a distance spherical component between -1.00 D and -5.50 D with cylinder in the range of 0.75 D to 2.25 D and cylinder axis within 10 ° of the vertical and within 20 ° of the horizontal in both eyes
✓. have a best corrected manifest refraction visual acuity of at least 20/25 or better in each eye.
✓. be in good general health, based on his/her knowledge.

Exclusion criteria

✕. The subject is a rigid gas permeable (RGP) or daily disposable soft lens wearer.
✕. 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.
✕. The presence of ocular or systemic disease or need for medication which might interfere with contact lens wear or which would cause the lenses to be removed more than twice a day. (i.e., Sjögren's syndrome, type II diabetes, etc).
✕. Slit lamp findings that would contraindicate contact lens wear such as:
✕. A history of recurrent erosions, corneal infiltrates, corneal ulcer or fungal infections.
✕. A known history of corneal hypoesthesia (reduced corneal sensitivity.)
✕. Aphakia, keratoconus or a highly irregular cornea.
✕. Current pregnancy or lactation (to the best of the subject's knowledge).

What they're measuring

Subjective Reported Vision

Timeframe: 1 week

Subject Reported Lens Comfort.

Timeframe: 1 week

Trial details

NCT IDNCT00584220

SponsorJohnson & Johnson Vision Care, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2007-12

Results submitted2009-08-21

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