Daily Disposable Silicone Hydrogel Contact Lens, Stenfilcon A, Clinical Study

CooperVision, Inc.106 enrolled

Overview

Clinical evaluation of stenfilcon A compared with narafilcon A and delefilcon A This is a total 120 subject, randomized, open label, bilateral wear, two week crossover study (each lens for 1 week) evaluating the clinical performance of stenfilcon A spherical lenses compared to narafilcon A or delefilcon A spherical lenses.

The aim of this study is to evaluate the clinical performance of stenfilcon A compared with narafilcon A and delefilcon A. The study participants will be allocated to two parallel groups (Group 1 and Group 2), 60 subjects each, based on the control lenses, narafilcon A and delefilcon A spherical lenses. Study groups: Group 1: stenfilcon A vs. narafilcon A Group 2: stenfilcon A vs. delefilcon A

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

NONE

Enrollment

106

Conditions

Myopia

Interventions

stenfilcon ADEVICE

contact lens

narafilcon ADEVICE

contact lens

delefilcon ADEVICE

contact lens

Eligibility

Sex: ALLMin age: 18 YearsMax age: 40 Years

Medical Language ↔ Plain English

Inclusion Criteria: \- A person is eligible for inclusion in the study if he/she: * Is over 18 years of age (inclusive) * Has had a self-reported visual exam in the last two years * Is an adapted daily disposable non-silicone hydrogel spherical contact lens wearer * Can achieve best corrected spectacle distance visual acuity of 20/25 or better in each eye. * Can achieve a distance visual acuity of 20/30 or better in each eye with the study contact lenses. * Has clear corneas and no active ocular disease * Has read, understood and signed the information consent letter. * Has a CL (Contact Lens) spherical prescription between - 0.75 and - 8.00 (inclusive) * Is willing to comply with the wear schedule. * Is willing to comply with the visit schedule Exclusion Criteria: \- A person will be excluded from the study if he/she: * Is not a habitual wearer of daily disposable non-silicone hydrogel spherical contact lenses * Has a CL prescription outside the range of the inclusion power range * Has a spectacle cylinder ≥1.00D of cylinder in either eye. * Has a history of not achieving comfortable CL wear (5 days per week; \> 8 hours/day) * Has contact lens best corrected distance vision worse than 20/25 in either eye * Presence of clinically significant (grade 2-4) anterior segment abnormalities * Presence of ocular or systemic disease or need of medications which might interfere with contact lens wear * Slit lamp findings that would contraindicate contact lens wear * Has a known history of corneal hypoesthesia (reduced corneal sensitivity) * Has aphakia, keratoconus or a highly irregular cornea. * Has undergone corneal refractive surgery. * Is participating in any other type of eye related clinical or research study.

Outcomes

Primary Outcomes

Pain and Foreign Body Sensation

Subjective ratings of pain and foreign body sensation for stenfilcon A/narafilcon A and stenfilcon A/delefilcon A assessed at 1 week. Grade 0-3, 0=No sensation, 1=Slightly: sometimes felt sensation without any trouble in wearing contact lenses, 2=Mild: always felt sensation without any trouble in wearing contact lenses, 3=Heavy: could not wear contact lense due to sensation

Time frame: 1 week

Itching Sensation on Removal

Subjective ratings of itching sensation on insertion for each lens pair assessed at 1 week. Grade 0-3, 0=No sensation, 1=Slightly: sometimes felt sensation without any trouble in wearing contact lenses, 2=Mild: always felt sensation without any trouble in wearing contact lenses, 3=Heavy: could not wear contact lense due to sensation

Time frame: 1 week

Red Eye Sensation

Subjective ratings of red eye sensation for stenfilcon A/narafilcon A and stenfilcon A/delefilcon A assessed at 1 week. Grade 0-3, 0=No sensation, 1=Slightly: sometimes felt sensation without any trouble in wearing contact lenses, 2=Mild: always felt sensation without any trouble in wearing contact lenses, 3=Heavy: could not wear contact lense due to sensation

Time frame: 1 week

Dryness

Subjective ratings of dryness (right after insertion, right before removal, all day long) for stenfilcon A/narafilcon A and stenfilcon A/delefilcon A assessed at 1 week. (Scale 0-10, 0=very dry, 10=no dryness at all.

Time frame: 1 week

Comfort

Subjective ratings of comfort (right after insertion, right before removal, all day long) for stenfilcon A/narafilcon A and stenfilcon A/delefilcon A assessed at 1 week. (Scale 0-10, 0=very poor comfort, 10=very good comfort).

Time frame: 1 week

Vision

Subjective ratings of vision (right after insertion, right before removal, all day long) for stenfilcon A/narafilcon A and stenfilcon A/delefilcon A assessed at 1 week. (Scale 0-10, 0=very poor vision, 10=very good vision).

Data from ClinicalTrials.gov

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Secondary Outcomes

Lens Fit - Horizontal Centration

Lens fit evaluation of horizontal centration for stenfilcon A/narafilcon A and stenfilcon A/delefilcon A assessed at baseline. (Temporal, Little temporal, Centered, Little nasal, Nasal)

Time frame: Baseline

Lens Fit - Horizontal Centration

Lens fit evaluation of horizontal centration for stenfilcon A/narafilcon A and stenfilcon A/delefilcon A assessed at 1 week. (Temporal, Little temporal, Centered, Little nasal, Nasal)

Time frame: 1 week

Lens Fit - Vertical Centration

Lens fit evaluation of vertical centration for stenfilcon A/narafilcon A and stenfilcon A/delefilcon A is assessed at baseline. (Upper, Little upper, Centered, Little lower, Lower)

Time frame: Baseline

Lens Fit - Vertical Centration

Lens fit evaluation of vertical centration for stenfilcon A/narafilcon A and stenfilcon A/delefilcon A is assessed at 1 week. (Upper, Little upper, Centered, Little lower, Lower)

Time frame: 1 week

Lens Fit - Post-blink Movement

Lens fit evaluation of post-blink movement for stenfilcon A/narafilcon A and stenfilcon A/delefilcon A is assessed at baseline. (Tight, Little tight, Optimal, Little loose, Loose)

Time frame: Baseline

Lens Fit - Post-blink Movement

Lens fit evaluation of post-blink movement for stenfilcon A/narafilcon A and stenfilcon A/delefilcon A is assessed at 1 week. (Tight, Little tight, Optimal, Little loose, Loose)

Time frame: 1 week

Lens Fit Overall

Lens fit evaluation overall for stenfilcon A/narafilcon A and stenfilcon A/delefilcon A is assessed at baseline. (Optimum, Good, Acceptable, Not acceptable (cannot wear))

Time frame: Baseline

Lens Fit Overall

Lens fit evaluation overall for stenfilcon A/narafilcon A and stenfilcon A/delefilcon A is assessed at 1 week. (Optimum, Good, Acceptable, Not acceptable (cannot wear))

Time frame: 1 week

Conjunctival Redness

Conjunctival redness for stenfilcon A/narafilcon A and stenfilcon A/delefilcon A is assessed at 1 week. (Grading scale 0-4, 0.5 steps 0=Normal, 1=Trace 2=MIld, 3=Moderate 4=Severe)

Time frame: 1 week

Limbal Redness

Limbal redness for stenfilcon A/narafilcon A and stenfilcon A/delefilcon A is assessed at 1 week. (Grading scale 0-4, 0.5 steps 0=Normal, 1=Trace 2=MIld, 3=Moderate 4=Severe)

Time frame: 1 week

Corneal Staining

Corneal staining for stenfilcon A/narafilcon A and stenfilcon A/delefilcon A is assessed at 1 week. (Grading scale 0-4, 0.5 steps 0=Normal, 1=Trace 2=MIld, 3=Moderate 4=Severe)

Time frame: 1 week

Corneal Neovascularization

Corneal neovascularization for stenfilcon A/narafilcon A and stenfilcon A/delefilcon A is assessed at 1 week. (Grading scale 0-4, 0.5 steps 0=Normal, 1=Trace 2=MIld, 3=Moderate 4=Severe)

Time frame: 1 week

Conjunctival Staining

Conjunctival staining for stenfilcon A/narafilcon A and stenfilcon A/delefilcon A is assessed at 1 week. (Grading scale 0-4, 0.5 steps 0=Normal, 1=Trace 2=MIld, 3=Moderate 4=Severe)

Time frame: 1 week

Corneal Oedema

Corneal oedema for for stenfilcon A/narafilcon A and stenfilcon A/delefilcon A is assessed at 1 week. (Grading scale 0-4, 0.5 steps 0=Normal, 1=Trace 2=MIld, 3=Moderate 4=Severe)

Time frame: 1 week

Papillary Conjunctivitis

Papillary conjunctivitis for stenfilcon A/narafilcon A and stenfilcon A/delefilcon A is assessed at 1 week. (Grading scale 0-4, 0.5 steps 0=Normal, 1=Trace 2=MIld, 3=Moderate 4=Severe)

Time frame: 1 week