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

NCT ID: NCT01669629

Last Updated: 2018-06-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 183 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-08-31
• Study Completion Date: 2012-11-30

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.

Conditions

Myopia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: OTHER
• Blinding Strategy: DOUBLE

Study Groups

Delefilcon A/ Etafilcon A

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

Group Type: EXPERIMENTAL

delefilcon A

Intervention Type: DEVICE

Daily wear soft contact lens for bilateral distance vision correction use.

etafilcon A

Intervention Type: DEVICE

Daily wear soft contact lens for bilateral distance vision correction use.

Etafilcon A / Delefilcon A

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

Group Type: EXPERIMENTAL

delefilcon A

Intervention Type: DEVICE

Daily wear soft contact lens for bilateral distance vision correction use.

etafilcon A

Intervention Type: DEVICE

Daily wear soft contact lens for bilateral distance vision correction use.

Interventions

delefilcon A

Daily wear soft contact lens for bilateral distance vision correction use.

Intervention Type: DEVICE

etafilcon A

Daily wear soft contact lens for bilateral distance vision correction use.

Intervention Type: DEVICE

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:

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Johnson & Johnson Vision Care, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Little Rock, Arkansas, United States

Bridgeport, Connecticut, United States

Tampa, Florida, United States

Blue Springs, Missouri, United States

Vestal, New York, United States

Raleigh, North Carolina, United States

Kittanning, Pennsylvania, United States

Warwick, Rhode Island, United States

Chamberlain, South Dakota, United States

Bartlett, Tennessee, United States

Countries

United States

Other Identifiers

CR-005199

Identifier Type: -

Identifier Source: org_study_id