Evaluation of Comfilcon A and Senofilcon A Lenses

Clinical Comfort Evaluation of Biofinity and Acuvue Oasys Lenses

Evaluation of Comfilcon A and Senofilcon A Lenses

Study Overview

• Status: Completed
• Conditions: Myopia
• Intervention / Treatment: Device: Senofilcon A; Comfilcon A; Device: 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.

• Study Type: Interventional
• Enrollment (Actual): 61
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77204
      • University of Houston College of Optometry, TERTC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: OTHER
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	Baseline Insertion, 10 Minutes, 5 hours and 10 hours

Collaborators and Investigators

• Sponsor: Coopervision, Inc.
• Investigators: Principal Investigator: Jan Bergmanson, OD, PhD, University of Houston College of Optometry, TERTC

Study record dates

Study Major Dates

• Study Start: August 1, 2012
• Primary Completion (ACTUAL): August 1, 2012
• Study Completion (ACTUAL): August 1, 2012

Study Registration Dates

• First Submitted: September 26, 2012
• First Submitted That Met QC Criteria: September 26, 2012
• First Posted (ESTIMATE): September 28, 2012

Study Record Updates

• Last Update Posted (ACTUAL): July 28, 2020
• Last Update Submitted That Met QC Criteria: July 19, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors; Myopia
• Other Study ID Numbers: CV-12-54