Multi-Center Clinical Evaluation of Two Reusable Soft Contact Lenses
Status: | Completed |
---|---|
Conditions: | Ocular |
Therapuetic Areas: | Ophthalmology |
Healthy: | No |
Age Range: | 18 - 50 |
Updated: | 10/26/2017 |
Start Date: | August 2015 |
End Date: | March 2016 |
The purpose of this study is to compare the subjective performance of comfilcon A lens
against samfilcon A lens after 4 weeks of reusable lens wear.
against samfilcon A lens after 4 weeks of reusable lens wear.
This will be a 90 subject, randomized, bilateral, subject-masked, dispensing, cross-over
study comparing comfilcon A versus samfilcon A lenses over 8 weeks of daily wear (2 x
4-weeks). Both eyes will wear the same lens (test or control) for 4 weeks in a randomized
fashion. Subjects will be masked to lens type and investigators will be masked to the lens
codes.
study comparing comfilcon A versus samfilcon A lenses over 8 weeks of daily wear (2 x
4-weeks). Both eyes will wear the same lens (test or control) for 4 weeks in a randomized
fashion. Subjects will be masked to lens type and investigators will be masked to the lens
codes.
Inclusion:
- Spherical distance Contact Lens prescription between -1.00 and -6.00D or +1.00 to
+4.00D in both eyes (inclusive)
- Adapted soft Contact Lens wearers (i.e. >1 month), daily disposable and reusable lens
wearers.
- Spectacle cylinder 0.75D in both eyes.
- Correctable to 6/9 (20/30) in both eyes
- Be between 18 and 50 years of age (inclusive)
- Able to read, comprehend and sign an informed consent
- Own a mobile phone and be willing to respond to Short Message Service (SMS) survey
- Willing to comply with the wear and study visit schedule
Exclusion:
- Existing Biofinity or Ultra wearers
- Any active corneal infection, injury or inflammation
- Systemic or ocular allergies, which might interfere with Contact Lens wear
- Systemic disease, which might interfere with Contact Lens wear
- Ocular disease, which might interfere with Contact Lens wear
- Strabismus or amblyopia
- Subjects who have undergone corneal refractive surgery
- Subjects with keratoconus or other severe corneal irregularity contraindicating lens
wear
- Pregnant or lactating
- Use of systemic/topical medication contraindicating Contact Lens wear
- Diabetic
- Site employees or family members of site employees
We found this trial at
3
sites
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