Performance of Aspheric Hydrogel Lenses After a Refit With Sphere Silicone Hydrogel Lenses for 4 Weeks

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03835078

Enrollment

Registered

2019-02-08

Start date

2019-01-01

Completion date

2019-07-06

Last updated

2020-06-11

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

Conditions

Ametropia

Brief summary

The aim of this prospective study is to evaluate the clinical performance of habitual wearers of methafilcon A aspheric lenses after a refit with fanfilcon A sphere lenses for 4 weeks of daily wear.

Interventions

DEVICEmethafilcon A contact lenses

Bilateral daily wear of methafilcon A contact lenses

DEVICEfanfilcon A contact lenses

Bilateral daily wear of fanfilcon A contact lenses

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

OTHER

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

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 (Diopter) 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 Contact Lens (CL) prescription outside the range of the available parameters of the study lenses * Has a spectacle cylinder of ≥ 1.00D (Diopter) in either eye * Has a history of not achieving comfortable Contact Lens (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

Design outcomes

Primary

Measure	Time frame	Description
Percentage of Participants With Lens Centration Assessment by the Investigator - Methafilcon A Contact Lenses	Baseline	Lens centration assessment using 3-point scale (1=optimal centration, 2=decentration acceptable, 3=decentration unacceptable).
Percentage of Participants With Lens Centration Assessment by the Investigator - Fanfilcon A Contact Lenses	Baseline	Lens centration assessment using 3-point scale (1=optimal centration, 2=decentration acceptable, 3=decentration unacceptable).
Percentage of Participants With Corneal Coverage Assessment by the Investigator - Methafilcon A Contact Lenses	Baseline	Corneal coverage is collected on a YES/NO response. Yes - lens covers the cornea, No - lens does not cover the cornea
Percentage of Participants With Corneal Coverage Assessment by the Investigator - Fanfilcon A Contact Lenses	Baseline	Corneal coverage is collected on a YES/NO response. Yes - lens covers the cornea, No - lens does not cover the cornea
Post-blink Movement Assessment by the Investigator - Methafilcon A Contact Lenses	Baseline	Post-blink movement, was rated at each visit using a 0-4 scale (0=Insufficient, unacceptable movement, 1=Minimal, but acceptable movement, 2=Optimal movement, 3=Moderate, but acceptable movement, 4=Excessive, unacceptable movement).
Post-blink Movement Assessment by the Investigator - Fanfilcon A Contact Lenses	Baseline	Post-blink movement, was rated at each visit using a 0-4 scale (0=Insufficient, unacceptable movement, 1=Minimal, but acceptable movement, 2=Optimal movement, 3=Moderate, but acceptable movement, 4=Excessive, unacceptable movement).
Lens Tightness Assessment by the Investigator - Methafilcon A Contact Lenses	Baseline	Lens tightness was assessed using the push-up test and a 0 - 100% continuous scale (where 0% =falls from cornea without lid support, 50% = optimum and 100%=no movement).
Lens Tightness Assessment by the Investigator - Fanfilcon A Contact Lenses	Baseline	Lens tightness was assessed using the push-up test and a 0 - 100% continuous scale (where 0% =falls from cornea without lid support, 50% = optimum and 100%=no movement).
Overall Lens Fit Acceptance by the Investigator - Methafilcon A Contact Lenses	Baseline	Lens fit acceptance was evaluated using a 0 - 4 scale 0=Should not be worn, 1=Borderline but unacceptable, 2=Minimal acceptable, early review, 3=Not perfect but okay to dispense, 4=perfect
Overall Lens Fit Acceptance by the Investigator - Fanfilcon A Contact Lenses	Baseline	Lens fit acceptance was evaluated using a 0 - 4 scale 0=Should not be worn, 1=Borderline but unacceptable, 2=Minimal acceptable, early review, 3=Not perfect but okay to dispense, 4=perfect

Secondary

Measure	Time frame	Description
Average Daily Wearing Time - Methafilcon A Contact Lenses	4 weeks	Average daily wearing time response by the subject
Average Daily Wearing Time - Fanfilcon A Contact Lenses	2 weeks	Average daily wearing time response by the subject.
Average Comfortable Wearing Time - Methafilcon A Contact Lenses	4 weeks	Average comfortable wearing time - response by the subject
Average Comfortable Wearing Time - Fanfilcon A Contact Lenses	2 weeks	Average comfortable wearing time - response by the subject

Countries

Mexico

Participant flow

Recruitment details

42 subjects were enrolled but three subjects did not satisfy the minimum number of days / hours of wear during the study and excluded from all the analysis.

Participants by arm

Arm	Count
Overall Study Total Participants	39
Total	39

Baseline characteristics

Characteristic	Overall Study	—
Age, Categorical <=18 years	0 Participants	—
Age, Categorical >=65 years	0 Participants	—
Age, Categorical Between 18 and 65 years	39 Participants	—
Age, Continuous	25.3 years STANDARD_DEVIATION 6.7	—
Race and Ethnicity Not Collected	—	— Participants
Region of Enrollment Mexico	39 participants	—
Sex: Female, Male Female	24 Participants	—
Sex: Female, Male Male	15 Participants	—

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	0 / 39	0 / 39
other Total, other adverse events	0 / 39	0 / 39
serious Total, serious adverse events	0 / 39	0 / 39

Outcome results

Primary

Lens Tightness Assessment by the Investigator - Fanfilcon A Contact Lenses

Lens tightness was assessed using the push-up test and a 0 - 100% continuous scale (where 0% =falls from cornea without lid support, 50% = optimum and 100%=no movement).

Time frame: 4 weeks

Arm	Measure	Value (MEAN)	Dispersion
Methalfilcon A Contact Lenses	Lens Tightness Assessment by the Investigator - Fanfilcon A Contact Lenses	50.51 units on a scale	Standard Deviation 3.2

Primary

Lens Tightness Assessment by the Investigator - Fanfilcon A Contact Lenses

Lens tightness was assessed using the push-up test and a 0 - 100% continuous scale (where 0% =falls from cornea without lid support, 50% = optimum and 100%=no movement).

Time frame: Baseline

Arm	Measure	Value (MEAN)	Dispersion
Methalfilcon A Contact Lenses	Lens Tightness Assessment by the Investigator - Fanfilcon A Contact Lenses	50.38 units on a scale	Standard Deviation 1.8

Primary

Lens Tightness Assessment by the Investigator - Fanfilcon A Contact Lenses

Lens tightness was assessed using the push-up test and a 0 - 100% continuous scale (where 0% =falls from cornea without lid support, 50% = optimum and 100%=no movement).

Time frame: 2 weeks

Arm	Measure	Value (MEAN)	Dispersion
Methalfilcon A Contact Lenses	Lens Tightness Assessment by the Investigator - Fanfilcon A Contact Lenses	50.64 units on a scale	Standard Deviation 3.3

Primary

Lens Tightness Assessment by the Investigator - Methafilcon A Contact Lenses

Lens tightness was assessed using the push-up test and a 0 - 100% continuous scale (where 0% =falls from cornea without lid support, 50% = optimum and 100%=no movement).

Time frame: 4 weeks

Arm	Measure	Value (MEAN)	Dispersion
Methalfilcon A Contact Lenses	Lens Tightness Assessment by the Investigator - Methafilcon A Contact Lenses	52.31 units on a scale	Standard Deviation 6.5

Primary

Lens Tightness Assessment by the Investigator - Methafilcon A Contact Lenses

Lens tightness was assessed using the push-up test and a 0 - 100% continuous scale (where 0% =falls from cornea without lid support, 50% = optimum and 100%=no movement).

Time frame: Baseline

Arm	Measure	Value (MEAN)	Dispersion
Methalfilcon A Contact Lenses	Lens Tightness Assessment by the Investigator - Methafilcon A Contact Lenses	53.59 units on a scale	Standard Deviation 9.6

Primary