Comparison of Two Daily Disposable Contact Lenses Over 1-week of Wear



Status:Completed
Conditions:Ocular
Therapuetic Areas:Ophthalmology
Healthy:No
Age Range:18 - 45
Updated:6/21/2018
Start Date:August 2012
End Date:November 2012

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This is a one week 2x2 crossover study comparing delefilcon A with etafilcon A, with a
primary hypothesis of comparing the handling of each lens. Additional secondary markers are
measured looking at subjective comfort and vision of the lenses.


Inclusion Criteria:

- The subject must be between 18 and 45 years of age (inclusive) with no presbyopic add.

- The subject must read, understand, and sign the STATEMENT OF INFORMED CONSENT and
receive a fully executed copy of the form. This should be recorded on the Case Report
Form (CRF).

- The subject must be willing to wear the study lenses for at least 8 hours per day, 7
days per week.

- The subject must be a current successful soft contact lens wearer in both eyes

- The subject must appear able and willing to adhere to the instructions set forth in
this clinical protocol.

- The subject's subjective refraction must result in a vertex corrected spherical
contact lens prescription in the range of -1.00D to -6.00D in each eye.

- The subject's refractive astigmatism must be less than or equal to 0.75D in both eyes.

- The subject must have best corrected visual acuity of 20/30 (6/9) or better in each
eye.

- The subject must require a visual correction in both eyes (no monofit or monovision
allowed).

- The subject must have normal eyes with no evidence of abnormality or disease. For the
purposes of this study a normal eye is defined as one having:

1. No amblyopia.

2. No evidence of lid abnormality or infection (including blepharitis/meibomitis).

3. No conjunctival abnormality or infection.

4. No clinically significant slit lamp findings (i.e. stromal edema,
vascularization, infiltrates or abnormal opacities).

5. No other active ocular disease.

Exclusion Criteria:

- Any ocular or systemic allergies or diseases that may interfere with contact lens
wear.

- Any systemic disease, autoimmune disease, or use of medication, which may interfere
with contact lens wear.

- Clinically significant (Grade 3 or 4) corneal edema, corneal vascularization, corneal
staining, or any other abnormalities of the cornea which would contraindicate contact
lens wear.

- Clinically significant (Grade 3 or 4) tarsal abnormalities or bulbar injection which
might interfere with contact lens wear.

- Any ocular infection.

- Any corneal distortion resulting from previous hard or rigid gas permeable contact
lens wear.

- Pregnancy or lactation.

- No extended wear in the last 3 months.

- Diabetes.

- Infectious diseases (e.g. hepatitis, tuberculosis) or an immunosuppressive disease
(e.g. HIV).

- Employee or family member of the staff of the investigational site.
We found this trial at
10
sites
Chamberlain, South Dakota 57325
878
mi
from 43215
Chamberlain, SD
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497
mi
from 43215
Bartlett, TN
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604
mi
from 43215
Blue Springs, MO
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522
mi
from 43215
Bridgeport, CT
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193
mi
from 43215
Kittanning, PA
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622
mi
from 43215
Little Rock, AR
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371
mi
from 43215
Raleigh, NC
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831
mi
from 43215
Tampa, FL
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391
mi
from 43215
Vestal, NY
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615
mi
from 43215
Warwick, RI
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