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

Completed · Not applicable

Conditions studied: Myopia

In brief

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.

Key facts

Study ID

NCT01669629

Run by

Johnson & Johnson Vision Care, Inc.

People needed

183

Starts

2012-08-01

Expected to finish

2012-11-01

Last updated by the study team

2018-06-19

Who can join

Age: 18 and older, up to 45. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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:
• No amblyopia.
• No evidence of lid abnormality or infection (including blepharitis/meibomitis).
• No conjunctival abnormality or infection.
• No clinically significant slit lamp findings (i.e. stromal edema, vascularization, infiltrates or abnormal opacities).
• No other active ocular disease.

You may not qualify if…

• 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.

Where it is running

• Study site — Little Rock, Arkansas, United States
• Study site — Bridgeport, Connecticut, United States
• Study site — Tampa, Florida, United States
• Study site — Blue Springs, Missouri, United States
• Study site — Vestal, New York, United States
• Study site — Raleigh, North Carolina, United States
• Study site — Kittanning, Pennsylvania, United States
• Study site — Warwick, Rhode Island, United States
• Study site — Chamberlain, South Dakota, United States
• Study site — Bartlett, Tennessee, United States

Full record on ClinicalTrials.gov

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