Clinical Validation of Biofinity Toric MTO (Made To Order) Lenses

CooperVision, Inc.30 enrolled

Overview

The study hypothesis is there is no difference in the clinical performance between the test and control lenses, in particular in lens stability, toric mislocation, comfort ratings and anterior segment ocular health findings.

Evaluate the clinical performance of Biofinity toric MTO lenses against current commercial Biofinity toric lenses over 6 hours of lens wear.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

SINGLE

Enrollment

Conditions

Myopia Astigmatism

Interventions

comfilcon A MTODEVICE

Randomized to a test lens in one eye and control lens in the other as a matched pair.

comfilcon ADEVICE

Randomized to a test lens in one eye and control lens in the other as a matched pair.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Has had a self-reported 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 20/40 or better (in each eye) with their habitual vision correction or 20/20 best-corrected. * Currently wears soft contact lenses. * Has clear corneas and no active ocular disease. * Has not worn lenses for at least 12 hours before the examination Exclusion Criteria: * Has never worn contact lenses before. * Has any systemic disease affecting ocular health. * Is using any systemic or topical medications that will affect ocular health. * Has any ocular pathology or severe insufficiency of lacrimal secretion (moderate to severe dry eyes) that would affect the wearing of contact lenses. * Has persistent, clinically significant corneal or conjunctival staining using sodium fluorescein dye. * Has any clinically significant lid or conjunctival abnormalities, active neovascularization or any central corneal scars. * Is aphakic. * Has undergone corneal refractive surgery. * Is participating in any other type of eye related clinical or research study.

Locations (1)

CORL, Indiana University

Bloomington, Indiana, United States

Outcomes

Primary Outcomes

Lens Surface Assessment of Study Lenses - Surface Wettability

Investigator's objective assessment of lens surface wettability at 15min and 6hrs. Scale (0-4; 0=non-wetting, 4=Excellent)

Time frame: 15min & 6hrs

Lens Surface Assessment of Study Lenses - Deposits

Investigator's objective assessment of lens surface deposition at 15min and 6hrs. Graded on the appearance of lens surface by slit lamp. Rated on a scale (0-4; 0=no deposits, 4=deposits ≥0.5mm or film \> 75% of surface)

Time frame: 15min & 6hrs

Lens Surface Assessment of Study Lenses - Surface Acceptance

Investigator's objective assessment of surface acceptance at 15min and 6hrs. Rated on a scale (0-4; 0=very poor, 4=excellent)

Time frame: 15min & 6hrs

Subjective Rating For Comfort - Comfort Since Last Visit

Participant's subjective rating of comfort now of study lenses. Surveyed at 15min, 3hr, and 6hr. Scale (0-100; 0=cannot be worn, causes pain, 100=cannot be felt ever)

Time frame: 15min, 3hrs, 6hrs

Subjective Rating For Comfort Preference

Participant's subjective rating of comfort preference of study lenses. Scale: (Strongly Prefer Right lens - Strongly Prefer Left Lens)

Time frame: 1min, 15min, 3hrs, 6hrs

Subjective Rating For Handling - Insertion

Participant's subjective rating for ease of insertion of the study lenses. Scale (0-100; 0=could not place lens on eye;100=always easy to place lens on eye)

Time frame: 1 min

Subjective Rating For Handling - Removal

Participant's subjective rating for ease of removal of study lenses. Scale (0-100; 0=could not remove lens from eye;100=always easy to place remove from eye)

Data from ClinicalTrials.gov

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