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

Not Applicable

Completed

• Conditions: Myopia
• Interventions: Device: stenfilcon A; Device: delefilcon A; Device: narafilcon A

• Registration Number: NCT02637804
• Lead Sponsor: Coopervision, Inc.

Brief Summary

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.

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 Timeline

• Study First Submitted: 2015-12-18
• Study First Submitted QC: 2015-12-18
• Study First Posted: 2015-12-22
• Study Start: 2016-01
• Primary Completion: 2016-03
• Study Completion: 2016-08
• Results First Submitted: 2017-08-15
• Status Verified: 2017-09
• Results First Submitted QC: 2017-09-21
• Last Update Submitted: 2017-09-21
• Results First Posted: 2017-10-23
• Last Update Posted: 2017-10-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 106

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
stenfilcon A vs narafilcon A (Group 1)	stenfilcon A	Participants are randomized to wear either stenfilcon A lens pair or narafilcon A lens pair, bilaterally, for 1 week during the cross over study.
stenfilcon A vs delefilcon A (Group 2)	delefilcon A	Participants are randomized to wear either stenfilcon A lens pair or delefilcon A lens pair, bilaterally, for 1 week during the cross over study.
stenfilcon A vs narafilcon A (Group 1)	narafilcon A	Participants are randomized to wear either stenfilcon A lens pair or narafilcon A lens pair, bilaterally, for 1 week during the cross over study.
stenfilcon A vs delefilcon A (Group 2)	stenfilcon A	Participants are randomized to wear either stenfilcon A lens pair or delefilcon A lens pair, bilaterally, for 1 week during the cross over study.

Primary Outcome Measures

Name	Time	Method
Dryness	1 week	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.
Comfort	1 week	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).
Vision	1 week	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).
Handling	1 week	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.
Lens Preference - Stenfilcon A/Narafilcon A (Group 1)	1 week	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).
Lens Preference - Stenfilcon A/Delefilcon A (Group 2)	1 week	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).
Pain and Foreign Body Sensation	1 week	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
Itching Sensation on Removal	1 week	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
Red Eye Sensation	1 week	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

Secondary Outcome Measures

Name	Time	Method
Lens Fit - Horizontal Centration	1 week	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)
Lens Fit - Vertical Centration	1 week	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)
Lens Fit - Post-blink Movement	1 week	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)
Lens Fit Overall	1 week	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))
Conjunctival Redness	1 week	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)
Limbal Redness	1 week	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)
Corneal Staining	1 week	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)
Corneal Neovascularization	1 week	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)
Conjunctival Staining	1 week	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)
Corneal Oedema	1 week	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)
Papillary Conjunctivitis	1 week	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)