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

Myopia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01669629
• Other study ID #: CR-005199
• Status: Completed
• Phase: N/A
• Start date: August 2012
• Est. completion date: November 2012

Study information

• Verified date: March 2016
• Source: Johnson & Johnson Vision Care, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 183
• Est. completion date: November 2012
• Est. primary completion date: November 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Myopia

Intervention

Device:
• delefilcon A
Daily wear soft contact lens for bilateral distance vision correction use.
• etafilcon A
Daily wear soft contact lens for bilateral distance vision correction use.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Johnson & Johnson Vision Care, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Subject Reported Ease of Removal	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.	6-10 Days
Secondary	Subject Reported Overall Comfort	Measured on a 5 point-scale of excellence (excellent, very good, good, fair and poor) per a participant. Summary is reported as an aggregate of Excellent/Very Good at their 1-week visit.	6-10 Days
Secondary	Subject Reported Overall Vision	Measured on a 5 point-scale of excellence (excellent, very good, good, fair and poor) per a participant using an aggregate summary of excellent/very good at their 1-week visit.	6-10 Days
Secondary	Binocular Snellen Visual Acuity	Snellen visual acuity percentage of eyes with a visual acuity of eyesight testing at a 20/20 level or better by eye.	6-10 Days
Secondary	Overall Corneal Staining	Proportion of subjects that have corneal staining on the 0-4 the NEI/Industry Workshop guidelines scale, measured by eye.; Grade 1 or higher is reported as a percentage of total eyes.	6-10 Days