Clinical trial NCT02670473: Clinical Performance of Existing Wearers of Enfilcon A Following a Refit With Fanfilcon A Lenses for 4 Weeks
Official title: Clinical Performance of Existing Wearers of Enfilcon A Following a Refit With Fanfilcon A Lenses for 4 Weeks
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Myopia
Lead sponsor: CooperVision International Limited (CVIL)
Sponsor class: INDUSTRY
First posted: 2016-02-01
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The aim of this dispensing study is to evaluate the clinical performance of habitual wearers of enfilcon A lenses following a refit with fanfilcon A lenses over 4 weeks of daily wear.

Detailed description: This is a 30 subject, prospective, dispensing, bilateral wear, subject-masked study, reviewing the refit characteristics in a group of enfilcon A wearers switched to the fanfilcon A lens. Subject's habitual enfilcon A lenses will be evaluated at the first vist and then re-fitted with a pair of fanfilcon A lenses for 4 weeks of daily wear. After the dispensing visit, subjects will return for evaluations at 1 week, 2 weeks, and 4 weeks.

Eligibility criteria: Inclusion criteria

A person is eligible for inclusion in the study if he/she:

* Is between 18 and 40 years of age
* Has had a self-reported visual exam in the last two years
* Is an adapted enfilcon A contact lens wearer (at least 2 weeks in enfilcon A lens)
* Has a contact lens spherical prescription between -1.00 to - 6.00
* Has a spectacle cylinder up to 0.75D (Diopters) in each eye.
* 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

A person will be excluded from the study if he/she:

* Is not a habitual wearer of enfilcon A lenses
* Has a CL (Contact Lens) prescription outside the range of the available parameters of the study lenses.
* Has a spectacle cylinder ≥1.00D of cylinder 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 3-4) 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 Fit - Centration
timeFrame: Baseline, 1 week, 2 weeks, and 4 weeks
measure: Lens Fit - Post-blink Movement
timeFrame: Baseline, 1 week, 2 weeks, and 4 weeks
measure: Lens Tightness on Push-up
timeFrame: Baseline, 1 week, 2 weeks, and 4 weeks
measure: Overall Fit Acceptance
timeFrame: Baseline, 1 week, 2 weeks, and 4 weeks
Secondary outcomes:
measure: Overall Comfort
timeFrame: Baseline, 1 week, 2 weeks, and 4 weeks
measure: Dryness Overall
timeFrame: Baseline, 1 week, 2 weeks, and 4 weeks
measure: Handling
timeFrame: Baseline, 1 week, 2 weeks, and 4 weeks
measure: Overall Vision Satisfaction
timeFrame: Baseline, 1 week, 2 weeks, and 4 weeks
measure: Overall Satisfaction
timeFrame: Baseline, 1 week, 2 weeks, and 4 weeks
measure: Lens Preference Overall
timeFrame: 1 week, 2 weeks, and 4 weeks
measure: Wearing Times
timeFrame: Baseline, 1 week, 2 weeks, and 4 weeks
measure: Conjunctival Staining
timeFrame: Baseline, 1 week, 2 weeks, and 4 weeks
measure: Corneal Staining
timeFrame: Baseline, 1 week, 2 weeks, and 4 weeks
Other outcomes:
Locations:
city: Valencia
country: Spain
facility: Optometry Research Group (GIO) Optics Department, University of Valencia
Study officials:
affiliation: Optometry Research Group (GIO) University of Valencia
name: Robert Montés-Mico, O.D., PhD
role: PRINCIPAL_INVESTIGATOR
References: