Performance of Fanfilcon A Toric Lenses After at Least One Month Wearing Enfilcon A Toric Lenses

Not Applicable

Completed

• Conditions: Astigmatism
• Interventions: Device: fanfilcon A

• Registration Number: NCT02921412
• Lead Sponsor: Coopervision, Inc.

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.

Study Timeline

• Study First Submitted: 2016-09-29
• Study First Submitted QC: 2016-09-29
• Study Start: 2016-10-01
• Study First Posted: 2016-10-03
• Primary Completion: 2017-02-01
• Study Completion: 2017-03-21
• Results First Submitted: 2017-12-22
• Results First Submitted QC: 2018-02-12
• Status Verified: 2018-03
• Results First Posted: 2018-03-13
• Last Update Submitted: 2018-03-13
• Last Update Posted: 2018-04-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 37

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
fanfilcon A	fanfilcon A	All participants wear enfilcon A toric lens (habitual) and then refitted with fanfilcon A toric lenses.

Primary Outcome Measures

Name	Time	Method
Fit Acceptability	baseline, 2 weeks, 1 month	Investigator fit acceptability for each lens pair. Scale 0-4: (0=should not be worn, 1=borderline but unacceptable, 2=minimally acceptable, early review, 3=not perfect but OK to dispense, 4=perfect)
Visual Acuity	baseline, 2 weeks, 1 month	High contrast distance visual acuity is measured by LogMAR.
Post-blink Movement	baseline, 2 weeks, 1 month	Post-blink lens movement assessed using the following evaluations (0-4): 0=Insufficient, unacceptable, 1=Minimal, acceptable, 2=Optimal, 3=Moderate, acceptable, 4=Excessive, unacceptable)
Centration	baseline, 2 weeks, 1 month	Lens centration is assessed (optimum, decentration acceptable, decentration unacceptable).
Corneal Coverage	baseline, 2 weeks, 1 month	Corneal coverage will be assessed (yes/no)

Trial Locations

Locations (4)

Hospital Contact Lens Service; 🇺🇸 Miami, Florida, United States

Debbie Kim; 🇺🇸 Closter, New Jersey, United States

West Village Eyecare; 🇺🇸 New York, New York, United States

Spokane Eye Clinic; 🇺🇸 Spokane, Washington, United States