Clinical trial NCT03974802: Refitting Somofilcon A Sphere Contact Lens Wearers Into Fanfilcon A Sphere Lenses for 4-Weeks of Wear
Official title: Refitting Somofilcon A Sphere Contact Lens Wearers Into Fanfilcon A Sphere Lenses for 4-Weeks of Wear
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Myopia
Lead sponsor: CooperVision International Limited (CVIL)
Sponsor class: INDUSTRY
First posted: 2019-06-05
Enrollment: 41
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: First pair of study lenses (habitual lenses) will be dispensed and worn for 4 weeks for daily wear, then second pair of lenses (test lenses) will be dispensed and worn for 4 weeks for daily wear.
Primary purpose: TREATMENT

Brief summary: The aim of this subject-masked prospective study is to evaluate the clinical performance of habitual wearers of Clariti Elite sphere lenses after a refit with Avaira Vitality sphere lenses.

Detailed description: The aim of this subject-masked prospective study is to evaluate the clinical performance of habitual wearers of Clariti Elite sphere lenses after a refit with Avaira Vitality sphere lenses for 4 weeks of daily wear.

Eligibility criteria: Inclusion Criteria:

* Is between 18 and 40 years of age (inclusive)
* Has had a self-reported visual exam in the last two years
* Is an adapted soft contact lens wearer
* Has a contact lens spherical prescription between - 0.25 to - 8.00 (inclusive)
* Have no less than -0.75D of astigmatism in both eyes.
* Can achieve best corrected spectacle distance visual acuity of 20/25 (0.10 logMAR) or better in each eye.
* Can achieve a distance visual acuity of 20/30 (0.18 logMAR) or better in each eye with the study contact lenses.
* Has clear corneas and no active ocular disease
* Has read, understood and signed the information consent letter.
* Patient contact lens refraction should fit within the available parameters of the study lenses.
* Is willing to comply with the wear schedule (at least 5 days per week, \> 8 hours/day assuming there are no contraindications for doing so).
* Is willing to comply with the visit schedule

Exclusion Criteria:

* Has a CL prescription outside the range of the available parameters of the study lenses.
* Has a spectacle cylinder of ≥ 1.00D in either eye.
* Has a history of not achieving comfortable CL wear (5 days per week; \> 8 hours/day)
* Has contact lens best corrected distance vision worse than 20/25 (0.10 logMAR) in either eye.
* Presence of clinically significant (grade 2-4) anterior segment abnormalities
* Presence of ocular or systemic disease or need of medications which might interfere with contact lens wear.
* Slit lamp findings that would contraindicate contact lens wear such as:

  * Pathological dry eye or associated findings
  * Pterygium, pinguecula, or corneal scars within the visual axis
  * Neovascularization \> 0.75 mm in from of the limbus
  * Giant papillary conjunctivitis (GCP) worse than grade 1
  * Anterior uveitis or iritis (past or present)
  * Seborrheic eczema, Seborrheic conjunctivitis
  * History of corneal ulcers or fungal infections
  * Poor personal hygiene
* Has a known history of corneal hypoesthesia (reduced corneal sensitivity)
* Has aphakia, keratoconus or a highly irregular cornea.
* Has Presbyopia or has dependence on spectacles for near work over the contact lenses.
* Has undergone corneal refractive surgery.
* Is participating in any other type of eye related clinical or research study.

Primary outcomes:
measure: Lens Centration for Somofilcon A (Habitual) Lens
timeFrame: Baseline
measure: Lens Centration for Somofilcon A (Habitual) Lens
timeFrame: 4- weeks
measure: Lens Centration for Fanfilcon A (Test) Lens
timeFrame: Baseline
measure: Lens Centration for Fanfilcon A (Test) Lens
timeFrame: 2-weeks
measure: Lens Centration for Fanfilcon A (Test) Lens
timeFrame: 4- weeks
measure: Lens Corneal Coverage for Somofilcon A (Habitual) Lens
timeFrame: Baseline
measure: Lens Corneal Coverage for Somofilcon A (Habitual) Lens
timeFrame: 4 -weeks
measure: Lens Corneal Coverage for Fanfilcon A (Test) Lens
timeFrame: Baseline
measure: Lens Corneal Coverage for Fanfilcon A (Test) Lens
timeFrame: 2-weeks
measure: Lens Corneal Coverage for Fanfilcon A (Test) Lens
timeFrame: 4-weeks
measure: Percentage of Lens Tightness for Somofilcon A (Habitual) Lens
timeFrame: Baseline
measure: Percentage of Lens Tightness for Somofilcon A (Habitual) Lens
timeFrame: 4-Weeks
measure: Percentage of Lens Tightness for Fanfilcon A (Test) Lens
timeFrame: Baseline
measure: Percentage of Lens Tightness for Fanfilcon A (Test) Lens
timeFrame: 2-Weeks
measure: Percentage of Lens Tightness for Fanfilcon A (Test) Lens
timeFrame: 4-Weeks
measure: Post-Blink Movement for Somofilcon A (Habitual) Lens
timeFrame: Baseline
measure: Post-Blink Movement for Somofilcon A (Habitual) Lens
timeFrame: 4-weeks
measure: Post-Blink Movement for Fanfilcon A (Test) Lens
timeFrame: Baseline
measure: Post-Blink Movement for Fanfilcon A (Test) Lens
timeFrame: 2-weeks
measure: Post-Blink Movement for Fanfilcon A (Test) Lens
timeFrame: 4-weeks
measure: Overall Lens Fit Acceptance for Somofilcon A (Habitual) Lens
timeFrame: Baseline
measure: Overall Lens Fit Acceptance for Somofilcon A (Habitual) Lens
timeFrame: 4-weeks
measure: Overall Lens Fit Acceptance for Fanfilcon A (Test) Lens
timeFrame: Baseline
measure: Overall Lens Fit Acceptance for Fanfilcon A (Test) Lens
timeFrame: 2-weeks
measure: Overall Lens Fit Acceptance for Fanfilcon A (Test) Lens
timeFrame: 4-weeks
Secondary outcomes:
measure: Average Daily Wearing Time - Somofilcon A (Habitual) Lens
timeFrame: 4-weeks
measure: Average Daily Wearing Time - Fanfilcon A (Test) Lens
timeFrame: 2-weeks
measure: Average Daily Wearing Time - Fanfilcon A (Test) Lens
timeFrame: 4-weeks
measure: Average Comfortable Wearing Time - Somofilcon A (Habitual) Lens
timeFrame: 4 weeks
measure: Average Comfortable Wearing Time - Fanfilcon A (Test) Lens
timeFrame: 2 weeks
measure: Average Comfortable Wearing Time - Fanfilcon A (Test) Lens
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Mexico City
country: Mexico
facility: Optometry Clinic, National Autonomous University
Study officials:
affiliation: School of Optometry, National Autonomous University (UNAM), Mexico City
name: Ruben Velázquez Guerrero, MSc., FIACLE
role: PRINCIPAL_INVESTIGATOR
References: