Clinical trial NCT01669629: Comparison of Two Daily Disposable Contact Lenses Over 1-week of Wear
Official title: Comparison of Two Daily Disposable Contact Lenses Over 1-week of Wear
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Myopia
Lead sponsor: Johnson & Johnson Vision Care, Inc.
Sponsor class: INDUSTRY
First posted: 2012-08-21
Enrollment: 183
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

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.


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.

Primary outcomes:
measure: Subject Reported Ease of Removal
timeFrame: 6-10 Days
Secondary outcomes:
measure: Subject Reported Overall Comfort
timeFrame: 6-10 Days
measure: Subject Reported Overall Vision
timeFrame: 6-10 Days
measure: Binocular Snellen Visual Acuity
timeFrame: 6-10 Days
measure: Overall Corneal Staining
timeFrame: 6-10 Days
Other outcomes:
Locations:
city: Little Rock
country: United States
state: Arkansas
city: Bridgeport
country: United States
state: Connecticut
city: Tampa
country: United States
state: Florida
city: Blue Springs
country: United States
state: Missouri
city: Vestal
country: United States
state: New York
city: Raleigh
country: United States
state: North Carolina
city: Kittanning
country: United States
state: Pennsylvania
city: Warwick
country: United States
state: Rhode Island
city: Chamberlain
country: United States
state: South Dakota
city: Bartlett
country: United States
state: Tennessee
Study officials:
References: