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Evaluation of Comfilcon A and Senofilcon A Lenses

Primary Purpose

Myopia

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Senofilcon A; Comfilcon A
Comfilcon A; Senofilcon A
Sponsored by
Coopervision, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Myopia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Houston College of Optometry, TERTC

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Senofilcon A

Comfilcon A

Arm Description

Senofilcon A; Comfilcon A

Comfilcon A; Senofilcon A

Outcomes

Primary Outcome Measures

Subjective Responses for Comfort Rated on a 0-100 Visual Scale.
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)

Secondary Outcome Measures

Full Information

First Posted
September 26, 2012
Last Updated
July 19, 2020
Sponsor
Coopervision, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT01695369
Brief Title
Evaluation of Comfilcon A and Senofilcon A Lenses
Official Title
Clinical Comfort Evaluation of Biofinity and Acuvue Oasys Lenses
Study Type
Interventional

2. Study Status

Record Verification Date
July 2020
Overall Recruitment Status
Completed
Study Start Date
August 2012 (undefined)
Primary Completion Date
August 2012 (Actual)
Study Completion Date
August 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Coopervision, Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Evaluation of Comfilcon A and Senofilcon A Lenses
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myopia

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
61 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Senofilcon A
Arm Type
Active Comparator
Arm Description
Senofilcon A; Comfilcon A
Arm Title
Comfilcon A
Arm Type
Experimental
Arm Description
Comfilcon A; Senofilcon A
Intervention Type
Device
Intervention Name(s)
Senofilcon A; Comfilcon A
Intervention Description
Senofilcon A; Comfilcon A
Intervention Type
Device
Intervention Name(s)
Comfilcon A; Senofilcon A
Intervention Description
Comfilcon A; Senofilcon A
Primary Outcome Measure Information:
Title
Subjective Responses for Comfort Rated on a 0-100 Visual Scale.
Description
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)
Time Frame
Baseline Insertion, 10 Minutes, 5 hours and 10 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jan Bergmanson, OD, PhD
Organizational Affiliation
University of Houston College of Optometry, TERTC
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Houston College of Optometry, TERTC
City
Houston
State/Province
Texas
ZIP/Postal Code
77204
Country
United States

12. IPD Sharing Statement

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Evaluation of Comfilcon A and Senofilcon A Lenses

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