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

Astigmatism Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02921412
• Other study ID #: EX-MKTG-67
• Status: Completed
• Phase: N/A
• First received: September 29, 2016
• Last updated: March 13, 2018
• Start date: October 1, 2016
• Est. completion date: March 21, 2017

Study information

• Verified date: March 2018
• Source: Coopervision, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a prospective, multi-center, subject-masked, bilateral, daily wear, two-month dispensing study

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 37
• Est. completion date: March 21, 2017
• Est. primary completion date: February 1, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 40 Years

Eligibility

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)

Related Conditions & MeSH terms

• Astigmatism

Intervention

Device:
• fanfilcon A
contact lens

Locations

Country	Name	City	State
United States	Debbie Kim	Closter	New Jersey
United States	Hospital Contact Lens Service	Miami	Florida
United States	West Village Eyecare	New York	New York
United States	Spokane Eye Clinic	Spokane	Washington

Sponsors (1)

Lead Sponsor	Collaborator
Coopervision, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Visual Acuity	High contrast distance visual acuity is measured by LogMAR.	baseline, 2 weeks, 1 month
Primary	Centration	Lens centration is assessed (optimum, decentration acceptable, decentration unacceptable).	baseline, 2 weeks, 1 month
Primary	Corneal Coverage	Corneal coverage will be assessed (yes/no)	baseline, 2 weeks, 1 month
Primary	Post-blink Movement	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)	baseline, 2 weeks, 1 month
Primary	Fit Acceptability	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)	baseline, 2 weeks, 1 month