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: April 1, 2013
Last verified: April 2013
  Purpose

Evaluation of two contact 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)

Further study details as provided by Coopervision, Inc.:

Primary Outcome Measures:
  • Patient Reported Outcomes [ Time Frame: Baseline, 5 hours and 10 hours ] [ Designated as safety issue: No ]

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

  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
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.
  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
Last Updated: April 1, 2013
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Myopia
Refractive Errors
Eye Diseases

ClinicalTrials.gov processed this record on May 16, 2013