Clinical trial NCT04050618: Evaluation Of One Silicone Hydrogel Contact Lens and Two Hydrogel Lenses in Daily Wear
Official title: Multi-Center Cross-Over Evaluation Of Avaira Vitality Silicone Hydrogel Contact Lens and Two Hydrogel Lenses in Daily Wear
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Myopia
Lead sponsor: CooperVision International Limited (CVIL)
Sponsor class: INDUSTRY
First posted: 2019-08-08
Enrollment: 114
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: To evaluate the comparative clinical performance of the fanfilcon A silicone hydrogel lens used in daily wear and to compare this with competitive hydrogel lens products.

Detailed description: This 8-week, subject-masked, bilateral, two-part, cross-over evaluation will compare the clinical performance of fanfilcon A silicone hydrogel contact lens and competitive hydrogel contact lenses when worn daily. Lenses will be replaced either on a 2-weekly or 4-weekly basis, depending on control lens group.

Eligibility criteria: Inclusion Criteria:

* Be a currently adapted soft contact lens wearer (\>1 month of lens wear).
* Be at least 18 years of age.
* Refractive astigmatism \<1.00D in both eyes.
* Have clear corneas and be free of any anterior segment disorders.
* Be correctable through spherocylindrical refraction to 20/25 or better in each eye.
* Contact lens sphere requirement between -1.00D and -6.00D (inclusive).
* Require visual correction in both eyes (monovision allowed, no monofit).
* Have normal eyes with no evidence of abnormality or disease. For the purposes of this study a normal eye is defined as one having:

  1. No amblyopia
  2. No strabismus
  3. No evidence of lid abnormality or infection
  4. No conjunctival abnormality or infection that would contraindicate contact lens wear
  5. No clinically significant slit lamp findings (i.e. corneal staining, stromal edema, staining, scarring, vascularization, infiltrates or abnormal opacities)
  6. No other active ocular disease.
* Own a mobile phone and be able to respond to SMS survey during the period 8am-8pm.
* Willing to comply with the wear and study visit schedule.

Exclusion Criteria:

* Using CooperVision Avaira Vitality, J\&J Acuvue 2 or CooperVision Biomedics 55.
* Require toric or multifocal contact lenses.
* Previously shown a sensitivity to any of the study solution components.
* Any systemic or ocular disease or allergies affecting ocular health.
* Using systemic or topical medications that will in the investigator's opinion affect ocular physiology or lens performance.
* Clinically significant (\>Grade 3) corneal staining, corneal stromal edema, corneal vascularization, tarsal abnormalities, bulbar hyperemia, limbal hyperemia, or any other abnormality of the cornea that would contraindicate contact lens wear.
* Any corneal infiltrates or any corneal scarring or neovascularization within the central 5mm of the cornea.
* Keratoconus or other corneal irregularity.
* Aphakia or amblyopia.
* Have undergone corneal refractive surgery or any anterior segment surgery.
* Abnormal lacrimal secretions.
* Has diabetes.
* Known/reported infectious disease (e.g., hepatitis, tuberculosis) or an immunosuppressive disease (e.g., HIV).
* History of chronic eye disease (e.g. glaucoma).
* Pregnant or lactating or planning a pregnancy at the time of enrolment.
* Participation in any concurrent clinical trial or in last 30 days.

Primary outcomes:
measure: Subjective Overall Comfort Rating
timeFrame: Two weeks
measure: Subjective Overall Comfort Rating
timeFrame: Four weeks
Secondary outcomes:
measure: Average Wearing Time
timeFrame: Two weeks
measure: Average Wearing Time
timeFrame: Four weeks
measure: Average Comfortable Wearing Time
timeFrame: Two weeks
measure: Average Comfortable Wearing Time
timeFrame: Four weeks
measure: Lens Centration
timeFrame: Baseline (after 15 minutes)
measure: Lens Centration
timeFrame: Two weeks
measure: Lens Centration
timeFrame: Four weeks
measure: Corneal Coverage
timeFrame: Baseline (after 15 minutes of lens dispense)
measure: Corneal Coverage
timeFrame: Two weeks
measure: Corneal Coverage
timeFrame: Four weeks
measure: Post-Blink Movement
timeFrame: Baseline (after 15 minutes of lens dispense)
measure: Post-Blink Movement
timeFrame: Two weeks
measure: Post-Blink Movement
timeFrame: Four weeks
measure: Lens Tightness - Push-up Test
timeFrame: Baseline (after 15 minutes of lens dispense)
measure: Lens Tightness - Push-up Test
timeFrame: Two weeks
measure: Lens Tightness - Push-up Test
timeFrame: Four weeks
measure: Overall Lens Fit Acceptance
timeFrame: Baseline (after 15 minutes of lens dispense)
measure: Overall Lens Fit Acceptance
timeFrame: Two weeks
measure: Overall Lens Fit Acceptance
timeFrame: Four weeks
measure: Rating of Lens Surface Wettability
timeFrame: Baseline (after 15 minutes of lens dispense)
measure: Rating of Lens Surface Wettability
timeFrame: Two weeks
measure: Rating of Lens Surface Wettability
timeFrame: Four weeks
measure: Presence of Film Deposits
timeFrame: Two weeks
measure: Presence of Film Deposits
timeFrame: Four weeks
measure: Number of White Spot Deposits
timeFrame: Two weeks
measure: Number of White Spot Deposits
timeFrame: Four weeks
measure: Primary Gaze Lag
timeFrame: Baseline (after 15 minutes of lens dispense)
measure: Primary Gaze Lag
timeFrame: Two weeks
measure: Primary Gaze Lag
timeFrame: Four weeks
measure: Comfort Throughout the Day
timeFrame: Day 3 - 8:00am
measure: Comfort Throughout the Day
timeFrame: Day 3 - 12:00pm
measure: Comfort Throughout the Day
timeFrame: Day 3 - 4:00pm
measure: Comfort Throughout the Day
timeFrame: Day 3 - 8:00pm
measure: Comfort Throughout the Day
timeFrame: Day 7 - 8:00am
measure: Comfort Throughout the Day
timeFrame: Day 7 - 12:00pm
measure: Comfort Throughout the Day
timeFrame: Day 7 - 4:00pm
measure: Comfort Throughout the Day
timeFrame: Day 7 - 8:00pm
measure: Comfort Throughout the Day
timeFrame: Day 12 - 8:00am
measure: Comfort Throughout the Day
timeFrame: Day 12 - 12:00pm
measure: Comfort Throughout the Day
timeFrame: Day 12 - 4:00pm
measure: Comfort Throughout the Day
timeFrame: Day 12 - 8:00pm
measure: Comfort Throughout the Day
timeFrame: Day 26 - 8:00am
measure: Comfort Throughout the Day
timeFrame: Day 26 - 12:00pm
measure: Comfort Throughout the Day
timeFrame: Day 26 - 4:00pm
measure: Comfort Throughout the Day
timeFrame: Day 26 - 8:00pm
Other outcomes:
Locations:
city: Whittier
country: United States
facility: Golden Optometric Group
state: California
city: Longwood
country: United States
facility: Omega Vision Center PA (DBA Sabal Eye Care)
state: Florida
city: Sarasota
country: United States
facility: Golden Vision
state: Florida
city: Vestal
country: United States
facility: Sacco Eye Group
state: New York
city: Tyler
country: United States
facility: Frazier Vision, Inc
state: Texas
city: Salt Lake City
country: United States
facility: Office of William J. Bogus, O.D.
state: Utah
Study officials:
affiliation: Golden Optometric Group
name: David C Ardaya, OD
role: PRINCIPAL_INVESTIGATOR
affiliation: Office of William J. Bogus, O.D.
name: William J Bogus, OD
role: PRINCIPAL_INVESTIGATOR
affiliation: Frazier Vision, Inc
name: Bryan E Frazier, OD
role: PRINCIPAL_INVESTIGATOR
affiliation: Golden Vision
name: Wayne Golden, OD
role: PRINCIPAL_INVESTIGATOR
affiliation: Sacco Eye Group
name: Andrew J Sacco, OD
role: PRINCIPAL_INVESTIGATOR
affiliation: Omega Vision Center PA (DBA Sabal Eye Care)
name: Christopher Pearson, OD
role: PRINCIPAL_INVESTIGATOR
References: