Refitting Somofilcon A Sphere Contact Lens Wearers Into Fanfilcon A Sphere Lenses for 4-Weeks of Wear

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03974802

Enrollment

Registered

2019-06-05

Start date

2019-05-14

Completion date

2019-08-28

Last updated

2020-08-18

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

Conditions

Myopia

Brief summary

The aim of this subject-masked prospective study is to evaluate the clinical performance of habitual wearers of Clariti Elite sphere lenses after a refit with Avaira Vitality sphere lenses.

Detailed description

The aim of this subject-masked prospective study is to evaluate the clinical performance of habitual wearers of Clariti Elite sphere lenses after a refit with Avaira Vitality sphere lenses for 4 weeks of daily wear.

Interventions

DEVICEsomofilcon A contact lens

Contact Lens

DEVICEfanfilcon A contact lens

Contact Lens

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Masking description

Study lenses will be transferred, by an assistant, out of their packaging to unmarked new contact lens cases filled with unpreserved sterile saline just prior to dispensing to maintain subject masking of the study lenses.

Intervention model description

First pair of study lenses (habitual lenses) will be dispensed and worn for 4 weeks for daily wear, then second pair of lenses (test lenses) will be dispensed and worn for 4 weeks for daily wear.

Eligibility

Sex/Gender

ALL

Age

18 Years to 40 Years

Healthy volunteers

Inclusion criteria

* Is between 18 and 40 years of age (inclusive) * Has had a self-reported visual exam in the last two years * Is an adapted soft contact lens wearer * Has a contact lens spherical prescription between - 0.25 to - 8.00 (inclusive) * Have no less than -0.75D of astigmatism in both eyes. * 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

* Has a CL prescription outside the range of the available parameters of the study lenses. * Has a spectacle cylinder of ≥ 1.00D 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 2-4) 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.

Design outcomes

Primary

Measure	Time frame	Description
Overall Lens Fit Acceptance for Fanfilcon A (Test) Lens	Baseline	Overall fit acceptance was measured using a scale of 0-4 (0= should not be worn, 1 = borderline but unacceptable, 2 = min. acceptable, early review, 3 = not perfect but OK to dispense, and 4 = perfect)
Percentage of Lens Tightness for Fanfilcon A (Test) Lens	Baseline	Lens Tightness: Push Up Test measured by 0% to 100% continuous scale (0%-falls from cornea without lid support, 50% = optimum, and 100% = no movement)
Post-Blink Movement for Somofilcon A (Habitual) Lens	Baseline	Post-Blink movement was measured on a scale 0-4 (0=Insufficient, unacceptable movement, 4 = Excessive, unacceptable movement)
Post-Blink Movement for Fanfilcon A (Test) Lens	Baseline	Post-Blink movement was measured on a scale 0-4 (0=Insufficient, unacceptable movement, 4 = Excessive, unacceptable movement)
Overall Lens Fit Acceptance for Somofilcon A (Habitual) Lens	Baseline	Overall fit acceptance was measured using a scale of 0-4 (0= should not be worn, 1 = borderline but unacceptable, 2 = min. acceptable, early review, 3 = not perfect but OK to dispense, and 4 = perfect)
Lens Centration for Somofilcon A (Habitual) Lens	Baseline	Lens Centration was measured using a 3-point scale (1=optimal centration, 2=decentration acceptable, 3=decentration unacceptable).
Lens Centration for Fanfilcon A (Test) Lens	Baseline	Lens Centration was measured using a 3-point scale (1=optimal centration, 2=decentration acceptable, 3=decentration unacceptable).
Lens Corneal Coverage for Somofilcon A (Habitual) Lens	Baseline	Lens Corneal Coverage was rated as either Yes or No (Yes = full corneal coverage all time / no= incomplete corneal coverage)
Lens Corneal Coverage for Fanfilcon A (Test) Lens	Baseline	Lens Corneal Coverage was rated as either Yes or No (Yes = full corneal coverage all time / no= incomplete corneal coverage)
Percentage of Lens Tightness for Somofilcon A (Habitual) Lens	Baseline	Lens Tightness: Push Up Test measured by 0% to 100% continuous scale (0%-falls from cornea without lid support, 50% = optimum, and 100% = no movement)

Secondary

Measure	Time frame	Description
Average Daily Wearing Time - Fanfilcon A (Test) Lens	2-weeks	Average daily wearing time for fanfilcon A (test) lens was measured in hours/day
Average Comfortable Wearing Time - Somofilcon A (Habitual) Lens	4 weeks	Average Comfortable Wearing Time - somofilcon A (habitual) Lens measured in hours/day. Assessed using typical time of day when subject first experiences lens awareness or irritation.
Average Comfortable Wearing Time - Fanfilcon A (Test) Lens	2 weeks	Average Comfortable Wearing Time - fanfilcon A (test) Lens measured in hours/day. Assessed using typical time of day when subject first experiences lens awareness or irritation.
Average Daily Wearing Time - Somofilcon A (Habitual) Lens	4-weeks	Average Daily Wearing Time for somofilcon A (Habitual) lens - measured by time hours/day

Countries

Mexico

Participant flow

Participants by arm

Arm	Count
Overall Study Participants wore somofilcon A lens (habitual) for 4- weeks and refitted with fanfilcon A lens (test) for 4-weeks. somofilcon A contact lens: Contact Lens fanfilcon A contact lens: Contact Lens	41
Total	41

Baseline characteristics

Characteristic	Overall Study	—
Age, Categorical <=18 years	0 Participants	—
Age, Categorical >=65 years	0 Participants	—
Age, Categorical Between 18 and 65 years	41 Participants	—
Age, Continuous	26.1 years STANDARD_DEVIATION 7.2	—
Race and Ethnicity Not Collected	—	— Participants
Region of Enrollment Mexico	41 participants	—
Sex: Female, Male Female	31 Participants	—
Sex: Female, Male Male	10 Participants	—

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	0 / 41	0 / 41
other Total, other adverse events	0 / 41	0 / 41
serious Total, serious adverse events	0 / 41	0 / 41

Outcome results

Primary

Lens Centration for Fanfilcon A (Test) Lens

Lens Centration was measured using a 3-point scale(1=optimal centration, 2=decentration acceptable, 3=decentration unacceptable).

Time frame: 4- weeks

Arm	Measure	Group	Value (NUMBER)
Somofilcon A (Habitual) Lens	Lens Centration for Fanfilcon A (Test) Lens	Optimum	100 percentage of participants
Somofilcon A (Habitual) Lens	Lens Centration for Fanfilcon A (Test) Lens	Decentration Acceptable	0 percentage of participants
Somofilcon A (Habitual) Lens	Lens Centration for Fanfilcon A (Test) Lens	Decentration Unacceptable	0 percentage of participants

Primary

Lens Centration for Fanfilcon A (Test) Lens

Lens Centration was measured using a 3-point scale (1=optimal centration, 2=decentration acceptable, 3=decentration unacceptable).

Time frame: Baseline

Arm	Measure	Group	Value (NUMBER)
Somofilcon A (Habitual) Lens	Lens Centration for Fanfilcon A (Test) Lens	Optimum	100 percentage of participants
Somofilcon A (Habitual) Lens	Lens Centration for Fanfilcon A (Test) Lens	Decentration Acceptable	0 percentage of participants
Somofilcon A (Habitual) Lens	Lens Centration for Fanfilcon A (Test) Lens	Decentration Unacceptable	0 percentage of participants

Primary

Lens Centration for Fanfilcon A (Test) Lens

Lens Centration was measured using a 3-point scale (1=optimal centration, 2=decentration acceptable, 3=decentration unacceptable).

Time frame: 2-weeks

Arm	Measure	Group	Value (NUMBER)
Somofilcon A (Habitual) Lens	Lens Centration for Fanfilcon A (Test) Lens	Optimum	100 percentage of participants
Somofilcon A (Habitual) Lens	Lens Centration for Fanfilcon A (Test) Lens	Decentration Acceptable	0 percentage of participants
Somofilcon A (Habitual) Lens	Lens Centration for Fanfilcon A (Test) Lens	Decentration Unacceptable	0 percentage of participants

Primary

Lens Centration for Somofilcon A (Habitual) Lens

Lens Centration was measured using a 3-point scale (1=optimal centration, 2=decentration acceptable, 3=decentration unacceptable).

Time frame: Baseline

Arm	Measure	Group	Value (NUMBER)
Somofilcon A (Habitual) Lens	Lens Centration for Somofilcon A (Habitual) Lens	Optimum	100 percentage of participants
Somofilcon A (Habitual) Lens	Lens Centration for Somofilcon A (Habitual) Lens	Decentration Acceptable	0 percentage of participants
Somofilcon A (Habitual) Lens	Lens Centration for Somofilcon A (Habitual) Lens	Decentration Unacceptable	0 percentage of participants

Primary

Lens Centration for Somofilcon A (Habitual) Lens

Lens Centration was measured using a 3-point scale (1=optimal centration, 2=decentration acceptable, 3=decentration unacceptable).

Time frame: 4- weeks

Arm	Measure	Group	Value (NUMBER)
Somofilcon A (Habitual) Lens	Lens Centration for Somofilcon A (Habitual) Lens	Optimum	100 percentage of participants
Somofilcon A (Habitual) Lens	Lens Centration for Somofilcon A (Habitual) Lens	Decentartion Acceptable	0 percentage of participants
Somofilcon A (Habitual) Lens	Lens Centration for Somofilcon A (Habitual) Lens	Decentration Unacceptable	0 percentage of participants

Primary

Lens Corneal Coverage for Fanfilcon A (Test) Lens

Lens Corneal Coverage was rated as either Yes or No (Yes = full corneal coverage all time / no= incomplete corneal coverage)

Time frame: 2-weeks

Arm	Measure	Group	Value (NUMBER)
Somofilcon A (Habitual) Lens	Lens Corneal Coverage for Fanfilcon A (Test) Lens	Yes	100 percentage of participants
Somofilcon A (Habitual) Lens	Lens Corneal Coverage for Fanfilcon A (Test) Lens	No	0 percentage of participants

Primary

Lens Corneal Coverage for Fanfilcon A (Test) Lens

Lens Corneal Coverage was rated as either Yes or No (Yes = full corneal coverage all time / no= incomplete corneal coverage)

Time frame: Baseline

Arm	Measure	Group	Value (NUMBER)
Somofilcon A (Habitual) Lens	Lens Corneal Coverage for Fanfilcon A (Test) Lens	No	0 percentage of participants
Somofilcon A (Habitual) Lens	Lens Corneal Coverage for Fanfilcon A (Test) Lens	Yes	100 percentage of participants

Primary

Lens Corneal Coverage for Fanfilcon A (Test) Lens

Lens Corneal Coverage was rated as either Yes or No (Yes = full corneal coverage all time / no= incomplete corneal coverage)

Time frame: 4-weeks

Arm	Measure	Group	Value (NUMBER)
Somofilcon A (Habitual) Lens	Lens Corneal Coverage for Fanfilcon A (Test) Lens	Yes	100 percentage of participants
Somofilcon A (Habitual) Lens	Lens Corneal Coverage for Fanfilcon A (Test) Lens	No	0 percentage of participants

Primary

Lens Corneal Coverage for Somofilcon A (Habitual) Lens

Lens Corneal Coverage was rated as either Yes or No (Yes = full corneal coverage all time / no= incomplete corneal coverage)

Time frame: Baseline

Arm	Measure	Group	Value (NUMBER)
Somofilcon A (Habitual) Lens	Lens Corneal Coverage for Somofilcon A (Habitual) Lens	Yes	100 percentage of participants
Somofilcon A (Habitual) Lens	Lens Corneal Coverage for Somofilcon A (Habitual) Lens	No	0 percentage of participants

Primary

Lens Corneal Coverage for Somofilcon A (Habitual) Lens

Lens Corneal Coverage was rated as either Yes or No (Yes = full corneal coverage all time / no= incomplete corneal coverage)

Time frame: 4 -weeks

Arm	Measure	Group	Value (NUMBER)
Somofilcon A (Habitual) Lens	Lens Corneal Coverage for Somofilcon A (Habitual) Lens	Yes	100 percentage of participants
Somofilcon A (Habitual) Lens	Lens Corneal Coverage for Somofilcon A (Habitual) Lens	No	0 percentage of participants

Primary

Overall Lens Fit Acceptance for Fanfilcon A (Test) Lens

Overall fit acceptance was measured using a scale of 0-4 (0= should not be worn, 1 = borderline but unacceptable, 2 = min. acceptable, early review, 3 = not perfect but OK to dispense, and 4 = perfect)

Time frame: Baseline

Arm	Measure	Value (MEAN)	Dispersion
Somofilcon A (Habitual) Lens	Overall Lens Fit Acceptance for Fanfilcon A (Test) Lens	3.95 units on a scale	Standard Deviation 0.2

Primary

Overall Lens Fit Acceptance for Fanfilcon A (Test) Lens

Time frame: 4-weeks

Arm	Measure	Value (MEAN)	Dispersion
Somofilcon A (Habitual) Lens	Overall Lens Fit Acceptance for Fanfilcon A (Test) Lens	3.98 units on a scale	Standard Deviation 0.2

Primary

Overall Lens Fit Acceptance for Fanfilcon A (Test) Lens

Time frame: 2-weeks

Arm	Measure	Value (MEAN)	Dispersion
Somofilcon A (Habitual) Lens	Overall Lens Fit Acceptance for Fanfilcon A (Test) Lens	3.98 units on a scale	Standard Deviation 0.2

Primary

Overall Lens Fit Acceptance for Somofilcon A (Habitual) Lens

Time frame: Baseline

Arm	Measure	Value (MEAN)	Dispersion
Somofilcon A (Habitual) Lens	Overall Lens Fit Acceptance for Somofilcon A (Habitual) Lens	3.85 units on a scale	Standard Deviation 0.4

Primary

Overall Lens Fit Acceptance for Somofilcon A (Habitual) Lens

Time frame: 4-weeks

Arm	Measure	Value (MEAN)	Dispersion
Somofilcon A (Habitual) Lens	Overall Lens Fit Acceptance for Somofilcon A (Habitual) Lens	3.83 units on a scale	Standard Deviation 0.5

Primary