Assessment of Daily Disposable Silicone Hydrogel Lens Wear



Status:Completed
Conditions:Ocular
Therapuetic Areas:Ophthalmology
Healthy:No
Age Range:15 - 39
Updated:6/21/2018
Start Date:January 2010
End Date:April 2011

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The purpose of this study is to evaluate the effect of an investigational silicone hydrogel
soft contact lens on new contact lens wearers (neophytes) compared to a control of spectacle
wearers.


Inclusion Criteria:

- Able to read, comprehend and sign an informed consent (or parental consent/subject
assent, as appropriate).

- Willing to comply with the study visit schedule.

- Ages 15 to 39.

- Has access to a cellular telephone with text messaging capabilities.

- Has a current pair of spectacles.

- 'Neophyte' - In this work, 'neophyte' will be taken to mean any subject who has never
been dispensed contact lenses. A subject who has taken part in a non-dispensing
clinical study or has been fitted with contact lenses in practice but never went on to
actually wear the lenses, will also be classified as a 'neophyte'.

- Spherical contact lens (CL) prescription between -0.75D and -6.00D and spectacle
cylinder equal to or less than 0.75 DC.

- Monocular best-corrected distance visual acuity (VA) ≥ 20/30 Snellen in each eye.

- Subject agrees to "intent" of wearing the CLs at minimum 6 hours/day for at least 4
days per week.

- They agree not to participate in other clinical research during the duration of this
study.

Exclusion Criteria:

- Active ocular allergy, infection, injury, inflammation, or abnormality (e.g.,
keratoconus) that might interfere with soft contact lens wear.

- Prior corneal refractive surgery or corneal irregularity (e.g., keratoconus).

- Systemic disease, which might interfere with contact lens wear.

- Medication usage that may be associated with eye dryness.

- Use of any topical medication such as eye drops or ointment.

- Pregnant or lactating (by self-report).

- Aphakia.

- Grade 2 or greater of any of the following ocular surface signs: corneal edema,
corneal vascularization, corneal staining, tarsal conjunctival changes or any other
abnormality, which would normally contraindicate contact lens wear.

- Have participated in any other clinical trial or research in the two weeks prior to
starting this study.
We found this trial at
1
site
281 W. Lane Ave
Columbus, Ohio 43210
(614) 292-6446
Ohio State University The Ohio State University’s main Columbus campus is one of America’s largest...
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Columbus, OH
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