Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study has been completed.
Information provided by (Responsible Party):
Coopervision, Inc. Identifier:
First received: January 10, 2011
Last updated: February 4, 2014
Last verified: January 2014

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

Condition Intervention Phase
Device: stenfilcon A contact lens
Device: ocufilcon B contact lens
Phase 0

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Evaluation of the CooperVision Stenfilcon A Soft Contact Lens for Daily Wear When Compared to the CooperVision Ocufilcon B Soft Contact Lens

Resource links provided by NLM:

Further study details as provided by Coopervision, Inc.:

Primary Outcome Measures:
  • Objective Assessment: Ocular Response - Biomicroscopy [ Time Frame: Change from baseline visit and all follow-ups visits ] [ Designated as safety issue: Yes ]

    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.

  • Comparison of Objective Findings - Number of Adverse Events in Unique Eyes [ Time Frame: Any occurrence from dispensing to month 3 visit ] [ Designated as safety issue: Yes ]

    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).

  • Comparison of Objective Findings for Contact Lens Visual Acuities - Snellen 20/25 VA or Better [ Time Frame: week 1 visit, week 2 visit, month 1 visit, month 2 visit combined ] [ Designated as safety issue: No ]

    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.

Secondary Outcome Measures:
  • Subjective Assessment of Contact Lens Comfort - No Symptoms of Discomfort [ Time Frame: Baseline, Week 1, Week 2, Month 1, Month 2, Month 3 ] [ Designated as safety issue: No ]

    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).

  • Evaluation of Average Lens Wearing Time - Average Daily Hours Worn [ Time Frame: Baseline, Week 1, Week 2, Month 1, Month 2, Month 3 ] [ Designated as safety issue: No ]
    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.

Enrollment: 90
Study Start Date: October 2010
Study Completion Date: April 2011
Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: CooperVision ClearSight™ 1 Day

Detailed Description:

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


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01354223

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

No publications provided

Responsible Party: Coopervision, Inc. Identifier: NCT01354223     History of Changes
Other Study ID Numbers: FC100239
Study First Received: January 10, 2011
Results First Received: October 23, 2013
Last Updated: February 4, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Coopervision, Inc.:
silicone hydrogel contact lens
stenfilcon A
ocufilcon B
daily disposable
substantial equivalence
CooperVision ClearSight™ 1 Day SCL processed this record on March 03, 2015