Clinical trial NCT02921412: Performance of Fanfilcon A Toric Lenses After at Least One Month Wearing Enfilcon A Toric Lenses
Official title: Performance of Fanfilcon A Toric Lenses After at Least One Month Wearing Enfilcon A Toric Lenses
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Astigmatism
Lead sponsor: CooperVision International Limited (CVIL)
Sponsor class: INDUSTRY
First posted: 2016-10-03
Enrollment: 37
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: This is a prospective, multi-center, subject-masked, bilateral, daily wear, two-month dispensing study

Detailed description: The aim of this study is to determine if adapted contact lens wearers enfilcon A toric lenses can be confidently refit into fanfilcon A toric lenses and can be successful after one month of daily wear.

Eligibility criteria: Inclusion Criteria:

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

* Is between 18 and 40 years of age (inclusive)
* Has had a self-reported eye exam in the last two years
* Is a habitual soft toric lens wearer
* Can be successfully fit with study lenses (≥ grade 2 fit acceptance)
* Has a contact lens spherical prescription between -1.00 to -6.00D with a cylinder between -0.75 and -1.75D (Diopters) (inclusive)
* Has a spectacle cylinder of at least 0.75D in each eye.
* Can achieve best corrected spectacle refraction 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
* Has a contact lens refraction that fits 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:

* Has a history of not achieving comfortable CL (Contact Lens) wear (5 days per week; \> 8 hours/day)
* Presents with clinically significant anterior segment abnormalities
* Presents with ocular or systemic disease or need of medications which might interfere with contact lens wear
* Presents with slit lamp findings that would contraindicate contact lens wear such as:

  * Pathological dry eye or associated findings
  * Significant pterygium, pinguecula, or corneal scars within the visual axis
  * Neovascularization \> 0.75 mm in from of the limbus
  * Anterior uveitis or iritis (or history in past year)
  * Seborrheic eczema of eyelid region, 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.
* Is frequently using rewetting/ lubricating eye drops (more than once per day)

Primary outcomes:
measure: Visual Acuity
timeFrame: baseline, 2 weeks, 1 month
measure: Centration
timeFrame: baseline, 2 weeks, 1 month
measure: Corneal Coverage
timeFrame: baseline, 2 weeks, 1 month
measure: Post-blink Movement
timeFrame: baseline, 2 weeks, 1 month
measure: Fit Acceptability
timeFrame: baseline, 2 weeks, 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: Miami
country: United States
facility: Hospital Contact Lens Service
state: Florida
city: Closter
country: United States
facility: Debbie Kim
state: New Jersey
city: New York
country: United States
facility: West Village Eyecare
state: New York
city: Spokane
country: United States
facility: Spokane Eye Clinic
state: Washington
Study officials:
References: