Clinical trial NCT02555722: Evaluation of the CooperVision, Inc. Fanfilcon A and Enfilcon A Daily Wear Contact Lenses When Used for Frequent Replacement for up to One (1) Month of Daily Wear
Official title: Evaluation of the CooperVision, Inc. Fanfilcon A and Enfilcon A Daily Wear Contact Lenses When Used for Frequent Replacement for up to One (1) Month of Daily Wear
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Myopia
Lead sponsor: CooperVision International Limited (CVIL)
Sponsor class: INDUSTRY
First posted: 2015-09-21
Enrollment: 92
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 is a masked, multi-center, daily wear, monthly replacement, bilateral, randomized, lens blocked (subjects remain in the same lens brand throughout the study) concurrent control study enrolling up to 90 subjects with a study duration of approximately three months. Subjects will be randomized into the study contact lenses in a two to one (2:1) ratio of fanfilcon A lens (test) to enfilcon A lens (control).

Detailed description: Subjects will be randomized into the study contact lenses in a two to one (2:1) ratio of fanfilcon A lens (test) to enfilcon A lens (control). This should result in a study population of approximately 60 test subjects and 30 control subjects.

Eligibility criteria: Inclusion Criteria:

* 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 at least 5 days per week for at least 8 hours per day for at least one month prior to participation in the study.
* Possess or obtain prior to dispensing, wearable and visually functional (20/40 or better) eyeglasses.
* Be in good general health, based on his/her knowledge.
* Require spectacle lens powers between -0.50 and -8.00 diopters sphere with no more than 1.50 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 than20/25 in each eye.
* To be eligible for lens dispensing, the subject must achieve 20/30 VA or better in each eye with the study lens and the investigator must judge the fit as acceptable or optimal.

Exclusion Criteria:

* Wearing lenses in a monovision modality and is unwilling to be fit with distance lenses in both eyes for the duration of the study. 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 during this trial or within 30 days prior to this study.
* To the best of the subject's knowledge, she is currently pregnant, 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 the ingredients used in the Multi-Purpose Disinfection Lens Care System (MPS) approved for use in the study and is unable or unwilling to use the alternate care system.
* Previous refractive surgery; or current or previous orthokeratology treatment.
* Is aphakic or pseudophakic.
* Ocular or systemic disease such as, but not limited to: anterior uveitis or iritis (past or present), glaucoma, Sjögren's syndrome, lupus erythematosus, scleroderma, keratoconus or uncontrolled diabetes.
* The need for topical ocular medications or any systemic medication which might interfere with contact lens wear or require the lenses to be removed during the day.
* The presence of clinically significant (grade 2, 3 or 4) anterior segment abnormalities; or the presence of any 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, iritis, bacterial 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

Primary outcomes:
measure: Epithelial Edema - Fanfilcon A Lens (Test)
timeFrame: Baseline, Week 1, Week 2, Month 1, Month 2, Month 3
measure: Epithelial Edema - Enfilcon A Lens (Control)
timeFrame: Baseline, Week 1, Week 2, Month 1, Month 2, Month 3
measure: Stromal Edema - Fanfilcon A Lens (Test)
timeFrame: Baseline, Week 1, Week 2, Month 1, Month 2, Month 3
measure: Stromal Edema - Enfilcon A Lens (Control)
timeFrame: Baseline, Week 1, Week 2, Month 1, Month 2, Month 3
measure: Corneal Infiltrates - Fanfilcon A Lens (Test)
timeFrame: Baseline, Week 1, Week 2, Month 1, Month 2, Month 3
measure: Corneal Infiltrates - Enfilcon A Lens (Control)
timeFrame: Baseline, Week 1, Week 2, Month 1, Month 2, Month 3
measure: Corneal Vascularization - Fanfilcon A Lens (Test)
timeFrame: Baseline, Week 1, Week 2, Month 1, Month 2, Month 3
measure: Corneal Vascularization - Enfilcon A Lens (Control)
timeFrame: Baseline, Week 1, Week 2, Month 1, Month 2, Month 3
measure: Corneal Staining - Fanfilcon A Lens (Test)
timeFrame: Baseline, Week 1, Week 2, Month 1, Month 2, Month 3
measure: Corneal Staining - Enfilcon A Lens (Control)
timeFrame: Baseline, Week 1, Week 2, Month 1, Month 2, Month 3
measure: Limbal Hyperemia - Fanfilcon A Lens (Test)
timeFrame: Baseline, Week 1, Week 2, Month 1, Month 2, Month 3
measure: Limbal Hyperemia - Enfilcon A Lens (Control)
timeFrame: Baseline, Week 1, Week 2, Month 1, Month 2, Month 3
measure: Bulbar Hyperemia - Fanfilcon A Lens (Test)
timeFrame: Baseline, Week 1, Week 2, Month 1, Month 2, Month 3
measure: Bulbar Hyperemia - Enfilcon A Lens (Control)
timeFrame: Baseline, Week 1, Week 2, Month 1, Month 2, Month 3
measure: Palpebral Conjunctiva - Fanfilcon A Lens (Test)
timeFrame: Baseline, Week 1, Week 2, Month 1, Month 2, Month 3
measure: Palpebral Conjunctiva - Enfilcon A Lens (Control)
timeFrame: Baseline, Week 1, Week 2, Month 1, Month 2, Month 3
measure: Visual Acuity - Fanfilcon A Lens (Test)
timeFrame: Week 1, Week 2, Month 1, Month 2, Month 3
measure: Visual Acuity - Enfilcon A Lens (Control)
timeFrame: Week 1, Week 2, Month 1, Month 2, Month 3
measure: Average Wearing Time - Fanfilcon A Lens (Test)
timeFrame: Baseline, Week 1, Week 2, Month 1, Month 2, Month 3
measure: Average Wearing Time - Enfilcon A Lens (Control)
timeFrame: Baseline, Week 1, Week 2, Month 1, Month 2, Month 3
Secondary outcomes:
measure: Comfort - Fanfilcon A Lens (Test)
timeFrame: Baseline, Week 1, Week 2, Month 1, Month 2, Month 3
measure: Comfort - Enfilcon A Lens (Control)
timeFrame: Baseline, 1 week, 2 weeks, 1 month, 2 months, 3 months follow-up
measure: Overall Vision Quality - Fanfilcon A Lens (Test)
timeFrame: Baseline, Week 1, Week 2, Month 1, Month 2, Month 3
measure: Overall Vision Quality - Enfilcon A Lens (Control)
timeFrame: Baseline, Week 1, Week 2, Month 1, Month 2, Month 3
measure: Ease of Insertion and Removal - Fanfilcon A Lens (Test)
timeFrame: Baseline, Week 1, Week 2, Month 1, Month 2, Month 3
measure: Ease of Insertion and Removal - Enfilcon A Lens (Control)
timeFrame: Baseline, Week 1, Week 2, Month 1, Month 2, Month 3
Other outcomes:
Locations:
city: San Diego
country: United States
facility: Eric White, O.D., Inc.
state: California
city: Torrance
country: United States
facility: Mark Nakano, O.D.
state: California
city: Denver
country: United States
facility: Advanced Family Eye Care
state: North Carolina
city: Athens
country: United States
facility: Quinn, Foster & Associates
state: Ohio
city: Beachwood
country: United States
facility: Western Reserve Vision Care, Inc.
state: Ohio
city: Brentwood
country: United States
facility: Primary Eyecare Group, P.C.
state: Tennessee
Study officials:
affiliation: Eric White, O.D., Inc.
name: Eric M White, OD
role: PRINCIPAL_INVESTIGATOR
affiliation: Primary Eyecare Group, P.C.
name: Peter T Van Hoven, OD
role: PRINCIPAL_INVESTIGATOR
affiliation: Advanced Family Eye Care
name: Amanda L Barker, OD
role: PRINCIPAL_INVESTIGATOR
affiliation: Mark Nakano, O.D.
name: Mark E Nakano, OD
role: PRINCIPAL_INVESTIGATOR
affiliation: Quinn, Foster & Associates
name: Thomas G Quinn, OD
role: PRINCIPAL_INVESTIGATOR
affiliation: Western Reserve Vision Care, Inc
name: Mary Jo Stiegemeier, OD
role: PRINCIPAL_INVESTIGATOR
References: