A Dispensing Clinical Trial of a Study Test Silicone Hydrogel Lens Against Control Lens Over 1 Week

CooperVision, Inc.41 enrolled

Overview

This is a 1-week dispensing, double-masked, randomized, bilateral study comparing the test lens against the control lens.

The order of lens wear (test lens first, control lens second or control lens first, test lens second) will be selected according to a randomization table. Both test and control lenses will be used in a daily wear modality for 1 week. It is anticipated that this study will involve following visits: Baseline (screening and dispense of 1st study pair of lenses, visit combined), 1-week visit (follow-up of the 1st study pair of lenses and dispense the 2nd study pair of lenses) and 2-week visit (1 week follow-up of the 2nd study pair of lenses).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Myopia

Interventions

silicone hydrogel lens (test)DEVICE

contact lens

enfilcon A lens (control)DEVICE

contact lens

Eligibility

Sex: ALLMin age: 17 Years

Medical Language ↔ Plain English

Inclusion criteria: -A person is eligible for inclusion in the study if he/she: * Is at least 17 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 correction and the assigned study lenses * Is an adapted soft contact lens wearer (For the purpose of this study: Current lens wear at least 3 days per week, 8 hours each day.) Exclusion Criteria: -A person will be excluded from the study if he/she: * Is participating in any concurrent clinical or research study * Has any known active\* ocular disease and/or infection * Has a systemic condition that in the opinion of the investigator may affect a study outcome variable\*\* * Is using any systemic or topical medications that in the opinion of the investigator may affect a study outcome variable * Has known sensitivity to the diagnostic pharmaceuticals to be used in the study * Is pregnant, lactating or planning a pregnancy at the time of enrolment (by verbal confirmation at the screening visit). * Is aphakic * Has undergone corneal refractive surgery. For the purposes of this study, active\* ocular disease is defined as infection or inflammation which requires therapeutic treatment. Mild (i.e. not considered clinically relevant) lid abnormalities (blepharitis, meibomian gland dysfunction, papillae), corneal and conjunctival staining and dry eye are not considered active ocular disease. Neovascularization and corneal scars are the result of previous hypoxia, infection or inflammation and are therefore not active. Participants will be excluded with significant slit lamp findings (e.g. infiltrates or other slit lamp findings Grade 3 or above: corneal edema, tarsal abnormalities, and conjunctival injection) or active ocular disease (e.g. glaucoma, history of recurrent corneal erosions, and intraocular infection or inflammation of an allergic, bacterial, or viral etiology) For the purposes of this study, participants will be excluded\*\*, if currently 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

Locations (1)

Center for Contact Lens Research, University of Waterloo

Waterloo, Ontario, Canada

Outcomes

Primary Outcomes

Comfort

Subjective ratings scale (0-100) assessed: 0=Cannot be worn, causes pain, 20=Frequently irritating, 40=Occasionally irritating, 60=Occasionally noticable but not irritating, 80=Rarely noticeable, 100=Cannot be felt ever. Time points for comfort: lens dispense at baseline, lens insertion at 1 week, and overall at 1 week.

Time frame: Baseline and 1 week

Dryness

Subjective ratings scale (0-100): 0=Cannot be worn, extremely dry, 20=Frequently Irritating, 40=Occasionally irritating, 60=Occasionally noticeable but not irritating, 80=Rarely noticeable, 100=No dryness experienced at any time. Time points for dryness: lens dispense at baseline, lens insertion at 1 week, and overall at 1 week.

Time frame: Baseline and 1 week

Secondary Outcomes

Lens Wettability

Grading scale 0-4, 0.25 steps, 0=excellent; 4=severely reduced.

Time frame: Baseline and 1 week

Surface Appearance

Grade ratings category (smooth, grainy, or other)

Time frame: Baseline

Surface Appearance

Grade ratings category (smooth, grainy, or other)

Time frame: 1 week

High Contrast Acuity at High Room Illumination

Logarithm of the Minimum Angle or Resolution (LogMAR) Chart

Time frame: Baseline and 1 week

Lens Deposition

Lens Deposits Scale 0-4, 0.25 steps. 0=excellent; 4=severely reduced

Time frame: Baseline and 1 week

Data from ClinicalTrials.gov

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