Clinical trial NCT01354223: Clinical Evaluation of Stenfilcon A Soft Contact Lens When Compared to Ocufilcon B Soft Contact Lens
Official title: Evaluation of the CooperVision Stenfilcon A Soft Contact Lens for Daily Wear When Compared to the CooperVision Ocufilcon B Soft Contact Lens
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Myopia
Keywords: silicone hydrogel contact lens
SHCL
stenfilcon A
ocufilcon B
daily disposable
substantial equivalence
CooperVision ClearSight™ 1 Day SCL
Lead sponsor: CooperVision International Limited (CVIL)
Sponsor class: INDUSTRY
First posted: 2011-05-16
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Eligibility criteria: 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.

Primary outcomes:
measure: Objective Assessment: Ocular Response - Biomicroscopy
timeFrame: Change from baseline visit and all follow-ups visits
measure: Comparison of Objective Findings - Number of Adverse Events in Unique Eyes
timeFrame: Any occurrence from dispensing to month 3 visit
measure: Comparison of Objective Findings for Contact Lens Visual Acuities - Snellen 20/25 VA or Better
timeFrame: week 1 visit, week 2 visit, month 1 visit, month 2 visit combined
Secondary outcomes:
measure: Subjective Assessment of Contact Lens Comfort - No Symptoms of Discomfort
timeFrame: Baseline, Week 1, Week 2, Month 1, Month 2, Month 3
measure: Evaluation of Average Lens Wearing Time - Average Daily Hours Worn
timeFrame: Baseline, Week 1, Week 2, Month 1, Month 2, Month 3
Other outcomes:
Locations:
city: San Diego
country: United States
facility: Eric M. White, OD, Inc.
state: California
city: East Lansing
country: United States
facility: Vision Care Associates
state: Michigan
city: Beachwood
country: United States
facility: Western Reserve Vision Care
state: Ohio
city: Brentwood
country: United States
facility: Primary Eyecare Group, P.C.
state: Tennessee
Study officials:
name: Stephen Byrnes, OD
role: PRINCIPAL_INVESTIGATOR
name: Lee Rigel, OD
role: PRINCIPAL_INVESTIGATOR
name: Mary Jo Stiegemeier, OD
role: PRINCIPAL_INVESTIGATOR
name: Peter Van Hoven, OD
role: PRINCIPAL_INVESTIGATOR
name: Eric White, OD
role: PRINCIPAL_INVESTIGATOR
References: