Skip to main content
OpenTrials
Completed

NCT Number: NCT01695369

Evaluation of Comfilcon A and Senofilcon A Lenses

Evaluation of Comfilcon A and Senofilcon A Lenses

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Houston College of Optometry, TERTC

Houston, Texas, 77204, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Senofilcon A; Comfilcon A

Device

Senofilcon A; Comfilcon A

Comfilcon A; Senofilcon A

Device

Comfilcon A; Senofilcon A

Primary outcomes

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

    Time frame: Baseline Insertion, 10 Minutes, 5 hours and 10 hours

    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)

Sponsors and collaborators

Lead sponsor

CooperVision, Inc.

Industry

Registry information

Official study title

Clinical Comfort Evaluation of Biofinity and Acuvue Oasys Lenses

Important dates

Study start
2012
Primary completion
2012
Study completion
2012
First posted
Sep 28, 2012
Registry last updated
Jul 28, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.