Evaluation of Comfilcon A and Senofilcon A Lenses

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Coopervision, Inc.
ClinicalTrials.gov Identifier:
NCT01695369
First received: September 26, 2012
Last updated: February 3, 2014
Last verified: February 2014
  Purpose

Evaluation of Comfilcon A and Senofilcon A Lenses


Condition Intervention Phase
Myopia
Device: Senofilcon A; Comfilcon A
Device: Comfilcon A; Senofilcon A
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Official Title: Clinical Comfort Evaluation of Biofinity and Acuvue Oasys Lenses

Further study details as provided by Coopervision, Inc.:

Primary Outcome Measures:
  • Subjective Responses for Comfort Rated on a 0-100 Visual Scale. [ Time Frame: Baseline Insertion, 10 Minutes, 5 hours and 10 hours ] [ Designated as safety issue: No ]
    Subjective Patient Ratings measured using a Visual Analog Scale on a 0-100. (0=Cannot be worn. Causes pain, 20=Frequently irritating, 40=Occasionally irritating, 60=Occasionally noticeable but not irritating, 80=Rarely noticeable, 100=Cannot be felt ever)


Enrollment: 61
Study Start Date: August 2012
Study Completion Date: August 2012
Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Senofilcon A
Senofilcon A; Comfilcon A
Device: Senofilcon A; Comfilcon A
Senofilcon A; Comfilcon A
Device: Comfilcon A; Senofilcon A
Comfilcon A; Senofilcon A
Experimental: Comfilcon A
Comfilcon A; Senofilcon A
Device: Senofilcon A; Comfilcon A
Senofilcon A; Comfilcon A
Device: Comfilcon A; Senofilcon A
Comfilcon A; Senofilcon A

Detailed Description:

Non-dispensing, single-masked, randomized, contralateral study comparing the test lens against the control lens. Each subject will be randomized to wear the test lens in one eye and the control lens in the other eye.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Subjects must satisfy the following conditions prior to inclusion in the study:

  • Has had an oculo-visual examination in the last two years
  • Is at least 18 years of age and has full legal capacity to volunteer
  • Has read and understood the information consent letter
  • Is willing and able to follow instructions and maintain the appointment schedule
  • Is correctable to a visual acuity of 20/30 or better (in each eye) with their habitual vision correction
  • Currently wears soft contact lenses at least 3 days a week, 8 hours a day
  • Has clear corneas and no active ocular disease
  • Has not worn lenses for at least 12 hours before the examination
  • Have normal eyes with no evidence of abnormality or disease. For the purposes of this study a normal eye is defined as one having:

    • No amblyopia
    • No evidence of lid abnormality or infection (e.g. entropion, ectropion, chalazia, recurrent styes)
    • No clinically significant slit lamp findings (e.g. infiltrates or other slit lamp findings Grade 2 or above: corneal edema, tarsal abnormalities, and conjunctival injection).
    • No other active ocular disease (e.g. glaucoma, history of recurrent corneal erosions, cornea [infiltrates], conjunctiva, lids, and intraocular infection or inflammation of an allergic, bacterial, or viral etiology)
    • No aphakia
    • Has prescription to match the available power range.

Exclusion Criteria:

Any of the following will render a subject ineligible for inclusion:

  • Greater than 0.75 of refractive astigmatism in either eye
  • Has never worn contact lenses before
  • Wears contact lenses on an extended wear basis
  • Has any systemic disease affecting ocular health
  • Is a known sufferer of ocular allergies
  • Is taking medication, such as oral antihistamines, antihistamine eye drops, oral and ophthalmic beta-adrenergic blockers (e.g. Propanolol, Timolol), anticholinergics, oral steroids and any prescribed or over-the-counter eye medication, except artificial tears or eye lubricants
  • Has any clinically significant lid or conjunctival abnormalities, neovascularization, corneal scars or corneal opacities
  • Is aphakic
  • Has undergone corneal refractive surgery.
  • Is wearing monovision
  • Is participating in any other type of clinical or research study
  • Female who is currently pregnant or is breast-feeding
  • Has > grade 1 ocular corneal staining in both type and extent by > grade 2 in either type or extent
  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: NCT01695369

Locations
United States, Texas
University of Houston College of Optometry, TERTC
Houston, Texas, United States, 77204
Sponsors and Collaborators
Coopervision, Inc.
Investigators
Principal Investigator: Jan Bergmanson, OD, PhD University of Houston College of Optometry, TERTC
  More Information

No publications provided

Responsible Party: Coopervision, Inc.
ClinicalTrials.gov Identifier: NCT01695369     History of Changes
Other Study ID Numbers: CV-12-54
Study First Received: September 26, 2012
Results First Received: November 1, 2013
Last Updated: February 3, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Myopia
Refractive Errors
Eye Diseases

ClinicalTrials.gov processed this record on July 20, 2014