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

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.

Study Overview

• Status: Completed
• Conditions: Myopia
• Intervention / Treatment: Device: stenfilcon A; Device: narafilcon A; Device: delefilcon A

Detailed Description

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
• Enrollment (Actual): 106
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: stenfilcon A vs narafilcon A (Group 1); Participants are randomized to wear either stenfilcon A lens pair or narafilcon A lens pair, bilaterally, for 1 week during the cross over study.	Device: stenfilcon A; contact lens; Device: narafilcon A; contact lens
Active Comparator: stenfilcon A vs delefilcon A (Group 2); Participants are randomized to wear either stenfilcon A lens pair or delefilcon A lens pair, bilaterally, for 1 week during the cross over study.	Device: stenfilcon A; contact lens; Device: delefilcon A; contact lens

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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	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	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.	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).	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).	1 week
Handling	Subjective ratings of handling (lens insertion and lens removal) for stenfilcon A/narafilcon A and stenfilcon A/delefilcon A assessed at 1 week. (Scale 0-10, 0=very poor handling, 10=very good handling.	1 week
Lens Preference - Stenfilcon A/Narafilcon A (Group 1)	Subjective ratings of lens preference for stenfilcon A/narafilcon A assessed at 1 week. (5 possible ratings: Prefer stenfilcon A, Little Prefer stenfilcon A, No preference, little prefer narafilcon A, prefer narafilcon A).	1 week
Lens Preference - Stenfilcon A/Delefilcon A (Group 2)	Subjective ratings of lens preference for stenfilcon A/narafilcon A assessed at 1 week. (5 possible ratings: Prefer stenfilcon A, Little Prefer stenfilcon A, No preference, little prefer delefilcon A, prefer delefilcon A).	1 week

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	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)	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)	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)	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)	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)	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))	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))	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)	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)	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)	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)	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)	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)	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)	1 week

Collaborators and Investigators

• Sponsor: Coopervision, Inc.
• Investigators: Principal Investigator: Yuji Kodama, MD, PhD, Director, Kodama Eye Clinic

Study record dates

Study Major Dates

• Study Start: January 1, 2016
• Primary Completion (Actual): March 1, 2016
• Study Completion (Actual): August 1, 2016

Study Registration Dates

• First Submitted: December 18, 2015
• First Submitted That Met QC Criteria: December 18, 2015
• First Posted (Estimate): December 22, 2015

Study Record Updates

• Last Update Posted (Actual): October 23, 2017
• Last Update Submitted That Met QC Criteria: September 21, 2017
• Last Verified: September 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors; Myopia
• Other Study ID Numbers: JP-MKTG-201512

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided