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 |
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.
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.
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