Clinical Evaluation of Two Daily Disposable Contact Lenses

Refractive Error Clinical Trial

Official title:

Clinical Evaluation of Two Daily Disposable Contact Lenses

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01875471
• Other study ID #: CR-5305
• Status: Completed
• Phase: N/A
• Start date: June 2013
• Est. completion date: August 2013

Study information

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

Clinical Trial Summary

The objective of this study is to compare the ease of removing two daily disposable soft contact lenses off the eye.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 279
• Est. completion date: August 2013
• Est. primary completion date: August 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria:

1. The subject must be between 18 and 45 years of age (inclusive)with no presbyopic add.

2. 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).

3. The subject must be willing to wear the study lenses for at least 8 hours per day, at least 6 days between visits.

4. The subject must be a current successful spherical soft contact lens wearer in both eyes.

5. The subject must appear willing and able to adhere to the instructions set forth in this clinical protocol.

6. The subject's subjective refraction must result in a vertex corrected spherical contact lens prescription in the range of -1.00D to -6.00D (inclusive) in each eye.

7. The subject's refractive astigmatism must be less than or equal to -0.75D in both eyes.

8. The subject must have corrective visual acuity of 6/9 (20/30) or better in each eye.

9. The subject must require a visual correction in both eyes (no monofit or monovision allowed).

Exclusion Criteria:

1. Any ocular or systemic allergies or diseases that may interfere with contact lens wear.

2. Any systemic disease, autoimmune disease, or use of medication, which may interfere with contact lens wear.

3. Clinically significant (Grade 3 or 4) corneal edema, corneal vascularization, corneal staining, or infiltrates or any other abnormalities of the cornea which would contraindicate contact lens wear.

4. Clinically significant (Grade 3 or 4) tarsal abnormalities or bulbar injection which might interfere with contact lens wear.

5. Any ocular infection.

6. Any corneal distortion resulting from previous hard or rigid gas permeable contact lens wear.

7. Currently pregnant or lactating (subject who become pregnant during the study will be discontinued).

8. Diabetes.

9. Infectious diseases (e.g. hepatitis, tuberculosis) or an immunosuppressive disease (e.g. HIV).

10. Amblyopia

11. Evidence of lid abnormality or infection (including blepharitis/meibomitis)

12. Conjunctival abnormality or infection.

13. Any active ocular disease.

14. Employee or family member of the staff of the investigational site.

Related Conditions & MeSH terms

• Refractive Error
• Refractive Errors

Intervention

Device:
• delefilcon A
Daily disposable soft contact lens to be worn at least 8 hours daily
• narafilcon A
Daily disposable contact lens to be worn at least 8 hours daily

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Johnson & Johnson Vision Care, Inc.

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Subjective Ease of Lens Removal	After 1-week of lens wear, each subject was asked to rate a question, 'Ease of taking the lenses off of your eyes', using 5-point scale (1=Excellent, 2=Very Good, 3=Good, 4=Fair, 5=Poor).	Day 7