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

NCT01354223 | Completed Results DMC

• 1 other identifier: FC100239
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 4

Brief Summary

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

Conditions

Myopia

Keywords

silicone hydrogel contact lens; SHCL; stenfilcon A; ocufilcon B; daily disposable; substantial equivalence; CooperVision ClearSight™ 1 Day SCL

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (2)

• Subjective Assessment of Contact Lens Comfort - No Symptoms of Discomfort

  Baseline, Week 1, Week 2, Month 1, Month 2, Month 3

• Evaluation of Average Lens Wearing Time - Average Daily Hours Worn

  Baseline, Week 1, Week 2, Month 1, Month 2, Month 3

Study Arms (2)

stenfilcon A contact lens

EXPERIMENTAL

Randomized to stenfilcon A contact lens worn in a daily wear, daily disposable mode

Device: stenfilcon A contact lens

ocufilcon B contact lens

ACTIVE COMPARATOR

Randomized to ocufilcon B contact lens worn in a daily wear, daily disposable mode

Device: ocufilcon B contact lens

Interventions

stenfilcon A contact lens DEVICE

Randomized to stenfilcon A contact lens worn in a daily wear, daily disposable mode

stenfilcon A contact lens

ocufilcon B contact lens DEVICE

Daily disposable contact lens worn in a daily wear, daily disposable mode

Also known as: CooperVision ClearSight™ 1 Day

ocufilcon B contact lens

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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:

Sponsors & Collaborators

• CooperVision, Inc.: lead

Study Sites (4)

Eric M. White, OD, Inc.

San Diego, California, 92123, United States

Location

Vision Care Associates

East Lansing, Michigan, 48823, United States

Location

Western Reserve Vision Care

Beachwood, Ohio, 44122, United States

Location

Primary Eyecare Group, P.C.

Brentwood, Tennessee, 37027, United States

Location

MeSH Terms

Conditions

Myopia

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases

Results Point of Contact

• Title: William J. Gleason, O.D.
• Organization: Foresight Regulatory Strategies, Inc.

978-658-6888

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 10, 2011
• First Posted: May 16, 2011
• Study Start: October 1, 2010
• Primary Completion: March 1, 2011
• Study Completion: April 1, 2011
• Last Updated: July 29, 2020
• Results First Posted: March 21, 2014

Record last verified: 2020-07

Locations

US (4)