Clinical Evaluation of Stenfilcon A Soft Contact Lens When Compared to Ocufilcon B Soft Contact Lens

Evaluation of the CooperVision Stenfilcon A Soft Contact Lens for Daily Wear When Compared to the CooperVision Ocufilcon B Soft Contact Lens

This study seeks to evaluate a new daily disposable contact lens compared to an existing daily disposable contact lens.

Study Overview

• Status: Completed
• Conditions: Myopia
• Intervention / Treatment: Device: stenfilcon A contact lens; Device: ocufilcon B contact lens

Detailed Description

This study is designed to evaluate the stenfilcon A contact lens to demonstrate substantial equivalence to the Ocufilcon B for market release.

• Study Type: Interventional
• Enrollment (Actual): 90
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • San Diego, California, United States, 92123
      • Eric M. White, OD, Inc.
  • Michigan
    • East Lansing, Michigan, United States, 48823
      • Vision Care Associates
  • Ohio
    • Beachwood, Ohio, United States, 44122
      • Western Reserve Vision Care
  • Tennessee
    • Brentwood, Tennessee, United States, 37027
      • Primary Eyecare Group, P.C.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

Prior to being considered eligible to participate in this study, each subject MUST:

• Be at least 18 years of age as of the date of evaluation for the study.

• Have:

  • Read the Informed Consent
  • been given an explanation of the Informed Consent
  • indicated understanding of the Informed Consent
  • signed the Informed Consent document.
• Be willing and able to adhere to the instructions set forth in this protocol and able to keep all specified appointments.
• Be an adapted, current full-time silicone hydrogel or soft contact lens wearer. An adapted full-time wearer is defined as wearing contact lenses on a daily basis for at least 8 hours per day for at least one month prior to participation in the study.
• Possess wearable and visually functional eyeglasses.
• Be in good general health, based on his/her knowledge.
• Require spectacle lens powers between -1.00 and -6.00 diopters sphere with no more than 1.00 diopter of refractive astigmatism and be willing to wear contact lenses in both eyes.
• Have manifest refraction Snellen visual acuities (VA) equal to or better than 20/25 in each eye.
• Upon completing the fitting process with the lenses to be worn in the study, have contact lens Snellen VA equal to or better than 20/30 in each eye.

Exclusion Criteria:

Subjects may not be enrolled in this study if any of the following apply: The subject is/has:

• Wearing lenses in a monovision modality and is unwilling to be fit with distance lenses in both eyes. NOTE: Subjects may not wear lenses in a monovision modality at any time during the study as it will interfere with the visual acuity analysis.
• Poor personal hygiene.
• Any active participation in another clinical trial within 30 days prior to this study.
• Currently pregnant (to the best of the subject's knowledge), is lactating or is planning a pregnancy within the next 3 months.
• A member, relative or household member of the investigator or of the investigational office staff.
• Has a known sensitivity to ingredients used in the over the counter contact lens lubricants approved for use in the study.
• Previous refractive surgery; or current or previous orthokeratology treatment.
• Is aphakic or psuedophakic.
• Ocular or systemic disease such as, but not limited to: anterior uveitis or iritis (past or present), glaucoma, Sjögren's syndrome, lupus erythematosus, sclerodermia, keratoconus or type II diabetes.
• The need for topical ocular medications or any medication which might interfere with contact lens wear or which would require the lenses to be removed during the day.
• The presence of clinically significant (grade 3 or 4) anterior segment abnormalities; inflammations such as iritis; or any infection of the eye, lids, or associated structures.
• A known history of corneal hypoesthesia (reduced corneal sensitivity), corneal ulcer, corneal infiltrates or fungal infections.
• A history of papillary conjunctivitis that has interfered with contact lens wear.

• Slit lamp findings that would contraindicate contact lens wear, including but not limited to:

  • Pathological dry eye or associated dry eye symptoms with decreased tear levels and punctuate staining > Grade 2
  • Pterygium
  • Corneal scars within the visual axis
  • Neovascularization or ghost vessels > 1.0 mm in from the limbus
  • Giant papillary conjunctivitis (GPC) of > Grade 2
  • Anterior uveitis or iritis
  • Seborrheic eczema, seborrheic conjunctivitis or blepharitis

To be eligible to be randomized for study product a subject must have ALL of the Inclusion Criteria and have NONE of the exclusion criteria present.

To be eligible for lens dispensing (either Test or Control), the subject's study lens contact lens visual acuity must be equal to or better than 20/30 in each eye.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: stenfilcon A contact lens; Randomized to stenfilcon A contact lens worn in a daily wear, daily disposable mode	Device: stenfilcon A contact lens; Randomized to stenfilcon A contact lens worn in a daily wear, daily disposable mode
Active Comparator: ocufilcon B contact lens; Randomized to ocufilcon B contact lens worn in a daily wear, daily disposable mode	Device: ocufilcon B contact lens; Daily disposable contact lens worn in a daily wear, daily disposable mode; Other Names: CooperVision ClearSight™ 1 Day

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Objective Assessment: Ocular Response - Biomicroscopy	The primary safety endpoint are the objective slit lamp findings associated with the stenfilcon A contact lenses compared with those same findings reported as associated with the ocufilcon B contact lenses. The incidence of biomicroscopy findings (0=not present, 4=severe) over the duration of the study with the highest reported grade was chosen for each unique eye. Biomicroscopy measurements were obtained at Baseline (baseline visit) and All Follow-Ups (week 1 visit, week 2 visit, month 1 visit, month 2 visit combined).The average grade for unique eyes with findings greater than 0 (none) is compared.	Change from baseline visit and all follow-ups visits
Comparison of Objective Findings - Number of Adverse Events in Unique Eyes	The primary safety endpoint in this evaluation will be a comparison of the objective findings of the number of adverse events in unique eyes associated with the stenfilcon A contact lenses compared with those same findings as associated with ocufilcon B contact lenses. The number of adverse events over the duration of the study was reported for each unique eye (bilateral or unilateral). Observations for adverse events were reported for any occurrence after dispensing (dispensing visit) through end of month 3 visit (month 3 visit).	Any occurrence from dispensing to month 3 visit
Comparison of Objective Findings for Contact Lens Visual Acuities - Snellen 20/25 VA or Better	The primary efficacy endpoint are the contact lens Snellen visual acuities (VA) of 20/25 VA or better associated with stenfilcon A compared with those same visual acuities associated with ocufilcon B. Snellen visual acuity (VA) examinations were performed at All Follow-up visits (week 1 visit, week 2 visit, month 1 visit, month 2 visit). The combined results of All Follow-up visits are compared.	week 1 visit, week 2 visit, month 1 visit, month 2 visit combined

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Subjective Assessment of Contact Lens Comfort - No Symptoms of Discomfort	The secondary efficacy endpoint is the subjective assessment of contact lens comfort associated with the stenfilcon A contact lens compared with the comfort associated with the ocufilcon B contact lens. Subjective comfort assessment is related by the percent number of unique eyes that were reported to have no symptoms of discomfort (0=no symtoms reported) graded on a severity scale of the reported symptoms (0=no symptoms reported, 4=severe) that was experienced over the past month prior to baseline at the baseline visit (Baseline) and any symptoms of discomfort that was experienced since the previous study visit at each scheduled follow-up visit (Week 1, Week 2, Month 1, Month 2, Month 3).	Baseline, Week 1, Week 2, Month 1, Month 2, Month 3
Evaluation of Average Lens Wearing Time - Average Daily Hours Worn	The secondary efficacy endpoint is the objective assessment of the lens average daily wearing times associated with the stenfilcon A compared with the lens average wearing times with the ocufilcon B contact lens. Objective average daily lens wearing time is measured in reported hours worn with the subject's habitual contact lenses recorded at baseline and after dispensing of study lenses recorded at Week 1, Week 2, Month 1, Month 2, Month 3.	Baseline, Week 1, Week 2, Month 1, Month 2, Month 3

Collaborators and Investigators

• Sponsor: CooperVision, Inc.
• Investigators: Principal Investigator: Stephen Byrnes, OD; Principal Investigator: Lee Rigel, OD; Principal Investigator: Mary Jo Stiegemeier, OD; Principal Investigator: Peter Van Hoven, OD; Principal Investigator: Eric White, OD

Study record dates

Study Major Dates

• Study Start: October 1, 2010
• Primary Completion (Actual): March 1, 2011
• Study Completion (Actual): April 1, 2011

Study Registration Dates

• First Submitted: January 10, 2011
• First Submitted That Met QC Criteria: May 13, 2011
• First Posted (Estimate): May 16, 2011

Study Record Updates

• Last Update Posted (Actual): July 29, 2020
• Last Update Submitted That Met QC Criteria: July 19, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Keywords: silicone hydrogel contact lens; SHCL; stenfilcon A; ocufilcon B; daily disposable; substantial equivalence; CooperVision ClearSight™ 1 Day SCL
• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors; Myopia
• Other Study ID Numbers: FC100239