Clinical Evaluation of Invigor Toric 1-Day Contact Lenses

CooperVision, Inc.10 enrolled

Overview

An evaluation of the clinical performance of the 1-day toric test contact lens compared to the 1-day toric control contact lens over one hour of lens wear.

A non-dispensing, double-masked, randomized, contralateral study comparing the 1-day toric test contact lens against the 1-day toric control contact lens to evaluate the clinical performance over one hour of lens wear. Each subject will be randomized to wear the test lens in one eye and the control lens in the other eye for each pair of lenses. Each subject will be asked to wear four pairs of contact lenses in the study

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Astigmatism

Interventions

1-day toric test contact lensDEVICE

somofilcon A 1-day toric test contact lens

1-day toric control contact lensDEVICE

somofilcon A 1-day toric control contact lens

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)

Clinical Optics Research Lab (CORL) Indiana University School of Optometry, Indiana University

Bloomington, Indiana, United States

Outcomes

Primary Outcomes

Visibility of Toric Mark

Toric Mark visible or not visible. Data for all 4 pairs were combined and analyzed (n=40 contact lenses).

Time frame: 1 hour

Degree of Lens Orientation

Average of lens toric mark mislocation from the resting toric mark away from the 6 o'clock position - measured in degrees. Data for all 4 pairs were combined and analyzed (n=40 contact lenses).

Time frame: Baseline

Degree of Lens Orientation

Average of lens toric mark mislocation from the resting toric mark away from the 6 o'clock position - measured in degrees. Data for all 4 pairs were combined and analyzed (n=40 contact lenses).

Time frame: 15 minutes

Degree of Lens Orientation

Average of lens toric mark mislocation from the resting toric mark away from the 6 o'clock position - measured in degrees. Data for all 4 pairs were combined and analyzed (n=40 contact lenses).

Time frame: 1 hour

Toric Stability

Toric stability (maximal and minimal differences between extreme gazes) measured in degrees for up, down, right, and left gazes. Data for all 4 pairs were combined and analyzed (n=40 contact lenses).

Time frame: 15 minutes

Toric Stability

Rotational stability (maximal and minimal differences between extreme gazes) measured in degrees for up, down, right, and left gazes. Data for all 4 pairs were combined and analyzed (n=40 contact lenses).

Time frame: 1 hour

Degree of Rotational Recovery

Rotational Recovery for nasal and temporal - measured in degrees. Data for all 4 pairs were combined and analyzed (n=40 contact lenses).

Data from ClinicalTrials.gov

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Secondary Outcomes

Measurement of Lens Horizontal Centration

Measurement of Lens Horizontal Centration in millimeters. Data for all 4 pairs were combined and analyzed (n=40 contact lenses).

Time frame: 15 Minutes

Measurement of Lens Horizontal Centration

Measurement of Lens Horizontal Centration in millimeters. Data for all 4 pairs were combined and analyzed (n=40 contact lenses).

Time frame: 1 hour

Measurement of Lens Vertical Centration

Lens Horizontal centration measured in mm. Data for all 4 pairs were combined and analyzed (n=40 contact lenses).

Time frame: 15 minutes

Measurement of Lens Vertical Centration

Lens Horizontal centration measured in mm. Data for all 4 pairs were combined and analyzed (n=40 contact lenses).

Time frame: 1 hour

Measurement of Lens Movement

Measurement of lens movement in millimeters. Data for all 4 pairs were combined and analyzed (n=40 contact lenses).

Time frame: 15 minutes

Measurement of Lens Movement

Measurement of lens movement in millimeters. Data for all 4 pairs were combined and analyzed (n=40 contact lenses).

Time frame: 1 hour

Lens Push-Up

Lens push-up measured in percentage. Data for all 4 pairs were combined and analyzed (n=40 contact lenses).

Time frame: 15 minutes

Lens Push-Up

Lens push-up measured in percentage. Data for all 4 pairs were combined and analyzed (n=40 control lenses).

Time frame: 1 hour

Primary Lens Gaze Lag

Primary lens gaze lag measured in millimeters. Data for all 4 pairs were combined and analyzed (n=40 contact lenses).

Time frame: 15 minutes

Primary Lens Gaze Lag

Primary lens gaze lag measured in millimeters. Data for all 4 pairs were combined and analyzed (n=40 contact lenses).

Time frame: 1 hour

General Lens Fit Acceptance

General lens fit acceptance and preference scale 0-4 (0 = unacceptable, 4 = optimal). Data for all 4 pairs were combined and analyzed (n=40 contact lenses).

Time frame: 15 minutes

General Lens Fit Acceptance

General lens fit acceptance and preference scale 0-4 (0 = unacceptable, 4 = optimal). Data for all 4 pairs were combined and analyzed (n=40 contact lenses).

Time frame: 1 hour

Up Gaze Lag

Up gaze lag measured in millimeters. Data for all 4 pairs were combined and analyzed (n=40 contact lenses).

Time frame: 15 minutes

Up Gaze Lag

Up gaze lag measured in millimeters. Data for all 4 pairs were combined and analyzed (n=40 contact lenses).

Time frame: 1 hour

General Lens Fit Preference

Investigator's general lens fit preference - Test lens, No preference, Control lens. Data for all 4 pairs were combined and analyzed (n=40 contact lenses).

Time frame: Baseline

General Lens Fit Preference

Investigator's general lens fit preference - Test lens, No preference, Control lens. Data for all 4 pairs were combined and analyzed (n=40 contact lenses).

Time frame: 1 hour