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

Johnson & Johnson (J&J)

Status: Completed

Conditions: Myopia

Treatments: Device: etafilcon A; Device: delefilcon A

Study type: Interventional

Funder types: Industry

Identifiers

NCT01669629

CR-005199

Details and patient eligibility

About

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.

Enrollment: 183 patients

Sex: All

Ages: 18 to 45 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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183 participants in 2 patient groups

Delefilcon A/ Etafilcon A

Experimental group

Description:

6-10 days of delefilcon A soft contact lens wear first, then 6-10 days of etafilcon A soft contact lens wear

Treatment:

Device: delefilcon A

Device: etafilcon A

Etafilcon A / Delefilcon A

Experimental group

Description:

6-10 days of etafilcon A soft contact lens wear first then 6-10 days of delefilcon A soft contact lens wear

Treatment:

Device: delefilcon A

Device: etafilcon A