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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02921412

Enrollment

Registered

2016-10-03

Start date

2016-10-01

Completion date

2017-03-21

Last updated

2018-04-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Astigmatism

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.

Interventions

DEVICEfanfilcon A

contact lens

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

18 Years to 40 Years

Healthy volunteers

Yes

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)

Design outcomes

Primary

Measure	Time frame	Description
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)
Visual Acuity	baseline, 2 weeks, 1 month	High contrast distance visual acuity is measured by LogMAR.
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)
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)

Countries

United States

Participant flow

Pre-assignment details

37 participants were initially enrolled (assigned a study ID), with 1 failing the screening. A total of 36 participants wore the control lens (enfilcon A toric) first and then refitted and dispensed the test lenses (fanfilcon A toric) at baseline visit. There were no discontinuations.

Participants by arm

Arm	Count
Enfilcon A Toric / Fanfilcon A Toric All participants wear enfilcon A toric lens (habitual) and then refitted with fanfilcon A toric lenses at baseline visit.	36
Total	36

Baseline characteristics

Characteristic	Enfilcon A Toric / Fanfilcon A Toric	—
Age, Continuous	29.4 years STANDARD_DEVIATION 6.7	—
Race and Ethnicity Not Collected	—	— Participants
Region of Enrollment United States	36 Participants	—
Sex: Female, Male Female	25 Participants	—
Sex: Female, Male Male	11 Participants	—

Adverse events

Event type	EG000 affected / at risk
deaths Total, all-cause mortality	0 / 36
other Total, other adverse events	0 / 36
serious Total, serious adverse events	0 / 36

Outcome results

Primary