NCT01669629
Completed
Not Applicable
Comparison of Two Daily Disposable Contact Lenses Over 1-week of Wear
ConditionsMyopia
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Myopia
- Sponsor
- Johnson & Johnson Vision Care, Inc.
- Enrollment
- 183
- Primary Endpoint
- Subject Reported Ease of Removal
- Status
- Completed
- Last Updated
- 7 years ago
Overview
Brief Summary
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.
Investigators
Eligibility Criteria
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:
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).
Outcomes
Primary Outcomes
Subject Reported Ease of Removal
Time Frame: 6-10 Days
Measured on a 5 point-scale of excellence (excellent, very good, good, fair and poor) per a participant. Outcome is reported as aggregate number of subjects who reported Excellent/Very Good at their 1-week visit.
Secondary Outcomes
- Binocular Snellen Visual Acuity(6-10 Days)
- Subject Reported Overall Vision(6-10 Days)
- Subject Reported Overall Comfort(6-10 Days)
- Overall Corneal Staining(6-10 Days)
Similar Trials
Completed
Not Applicable
Evaluation of Etafilcon A Daily Disposable LensesMyopiaNCT02061592Johnson & Johnson Vision Care, Inc.136
Completed
Not Applicable
Daily Disposable Silicone Hydrogel Contact Lens, Stenfilcon A, Clinical StudyMyopiaNCT02637804Coopervision, Inc.106
Completed
Not Applicable
Clinical Evaluation of Etafilcon A Contact Lenses Using a Novel Manufacturing TechnologyVisual AcuityNCT03962790Johnson & Johnson Vision Care, Inc.95
Completed
Not Applicable
Clinical Comparison of Two Daily Disposable Toric LensesMyopiaAstigmatismNCT01362894CIBA VISION240
Completed
Not Applicable
Evaluation of Two Daily Disposable Contact Lenses for Wearers With AstigmatismAstigmatismMyopiaNCT01207466CIBA VISION95