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 |
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.
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
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