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Clinical Evaluation of Two Daily Disposable Contact Lenses

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01875471
Recruitment Status : Completed
First Posted : June 11, 2013
Results First Posted : June 4, 2015
Last Update Posted : June 19, 2018
Sponsor:
Information provided by (Responsible Party):
Johnson & Johnson Vision Care, Inc.

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

Condition or disease Intervention/treatment Phase
Refractive Error Device: delefilcon A Device: narafilcon A Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 279 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Other
Official Title: Clinical Evaluation of Two Daily Disposable Contact Lenses
Study Start Date : June 2013
Actual Primary Completion Date : August 2013
Actual Study Completion Date : August 2013

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Arms and Interventions
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Arm Intervention/treatment
Active Comparator: delefilcon A
Spherical daily disposable soft contact lens
 Device: delefilcon A
Daily disposable soft contact lens to be worn at least 8 hours daily
Other Name: DAILIES Total 1
Experimental: narafilcon A
Spherical daily disposable soft contact lens Class 1 UV blocking
 Device: narafilcon A
Daily disposable contact lens to be worn at least 8 hours daily
Other Name: 1-Day ACUVUE TruEye


Outcome Measures
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Primary Outcome Measures :
  1. Subjective Ease of Lens Removal [ Time Frame: Day 7 ]
    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).


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01875471


Locations
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United Kingdom
Knowle, Bristol, United Kingdom, BS4 2AL
Portchester, Hampshire, United Kingdom, PO16 9UN
Hay-on-Wye, Herefordshire, United Kingdom, HR3 5EQ
St. Albans, Herts, United Kingdom, AL1 3LH
Eastcote, Pinner, Middlesex, United Kingdom, HA5 1RJ
Cardiff, South Glamorgan, United Kingdom, CF24 3RQ
Farnham, Surrey, United Kingdom, GU9 7EN
Brighton, United Kingdom, BN1 1RH
London, United Kingdom, N2 8AG
London, United Kingdom, NW4 3FB
Norwich, United Kingdom, NR2 1PB
Sponsors and Collaborators
Johnson & Johnson Vision Care, Inc.
More Information
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Responsible Party: Johnson & Johnson Vision Care, Inc.
ClinicalTrials.gov Identifier: NCT01875471    
Other Study ID Numbers: CR-5305
First Posted: June 11, 2013    Key Record Dates
Results First Posted: June 4, 2015
Last Update Posted: June 19, 2018
Last Verified: May 2016
Additional relevant MeSH terms:
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Refractive Errors
Eye Diseases