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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Vistakon
ClinicalTrials.gov Identifier:
NCT01669629
First received: August 16, 2012
Last updated: May 5, 2014
Last verified: May 2014
  Purpose

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.


Condition Intervention
Myopia
Device: delefilcon A
Device: etafilcon A

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Official Title: Comparison of Two Daily Disposable Contact Lenses Over 1-week of Wear

Resource links provided by NLM:


Further study details as provided by Vistakon:

Primary Outcome Measures:
  • Subject Reported Ease of Removal [ Time Frame: 6-10 Days ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Subject Reported Overall Comfort [ Time Frame: 6-10 Days ] [ Designated as safety issue: No ]
    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.

  • Subject Reported Overall Vision [ Time Frame: 6-10 Days ] [ Designated as safety issue: No ]
    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.

  • Binocular Snellen Visual Acuity [ Time Frame: 6-10 Days ] [ Designated as safety issue: No ]
    Snellen visual acuity percentage of eyes with a visual acuity of eyesight testing at a 20/20 level or better by eye.

  • Overall Corneal Staining [ Time Frame: 6-10 Days ] [ Designated as safety issue: No ]

    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.



Enrollment: 183
Study Start Date: August 2012
Study Completion Date: November 2012
Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Delefilcon A/ Etafilcon A
6-10 days of delefilcon A soft contact lens wear first, then 6-10 days of etafilcon A soft contact lens wear
Device: delefilcon A
Daily wear soft contact lens for bilateral distance vision correction use.
Device: etafilcon A
Daily wear soft contact lens for bilateral distance vision correction use.
Experimental: Etafilcon A / Delefilcon A
6-10 days of etafilcon A soft contact lens wear first then 6-10 days of delefilcon A soft contact lens wear
Device: delefilcon A
Daily wear soft contact lens for bilateral distance vision correction use.
Device: etafilcon A
Daily wear soft contact lens for bilateral distance vision correction use.

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  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: NCT01669629

Locations
United States, Arkansas
Little Rock, Arkansas, United States, 72116
United States, Connecticut
Bridgeport, Connecticut, United States, 06610
United States, Florida
Tampa, Florida, United States, 33625
United States, Missouri
Blue Springs, Missouri, United States, 64015
United States, New York
Vestal, New York, United States, 13850
United States, North Carolina
Raleigh, North Carolina, United States, 27615
United States, Pennsylvania
Kittaning, Pennsylvania, United States, 16201
United States, Rhode Island
Warwick, Rhode Island, United States, 02888
United States, South Dakota
Chamberlain, South Dakota, United States, 57325
United States, Tennessee
Bartlett, Tennessee, United States, 38134
Sponsors and Collaborators
Vistakon
  More Information

No publications provided

Responsible Party: Vistakon
ClinicalTrials.gov Identifier: NCT01669629     History of Changes
Other Study ID Numbers: CR-005199
Study First Received: August 16, 2012
Results First Received: December 9, 2013
Last Updated: May 5, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Myopia
Refractive Errors
Eye Diseases

ClinicalTrials.gov processed this record on August 28, 2014