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Clinical Evaluation of Two Daily Disposable Contact Lenses

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Vistakon
ClinicalTrials.gov Identifier:
NCT01875471
First received: June 7, 2013
Last updated: September 5, 2013
Last verified: September 2013
  Purpose

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


Condition Intervention
Refractive Error
Device: delefilcon A
Device: narafilcon A

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Official Title: Clinical Evaluation of Two Daily Disposable Contact Lenses

Resource links provided by NLM:


Further study details as provided by Vistakon:

Primary Outcome Measures:
  • Ease of Removal of the Contact Lens as a Subject Reported Outcome [ Time Frame: Day 7 ] [ Designated as safety issue: No ]
    At the end of seven days of daily wear, each subject will be asked to complete a questionnaire regarding the level of ease of removal of the soft contact lens from their eyes.


Enrollment: 279
Study Start Date: June 2013
Study Completion Date: August 2013
Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 2 UV blocking
Device: narafilcon A
Daily disposable contact lens to be worn at least 8 hours daily
Other Name: 1-Day ACUVUE TruEye

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01875471

Locations
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, NW4 3FB
London, United Kingdom, N2 8AG
Norwich, United Kingdom, NR2 1PB
Sponsors and Collaborators
Vistakon
  More Information

No publications provided

Responsible Party: Vistakon
ClinicalTrials.gov Identifier: NCT01875471     History of Changes
Other Study ID Numbers: CR-5305
Study First Received: June 7, 2013
Last Updated: September 5, 2013
Health Authority: United Kingdom: National Institute for Health Research

Additional relevant MeSH terms:
Refractive Errors
Eye Diseases

ClinicalTrials.gov processed this record on November 20, 2014